Pediatrics

Nearly 40% of girls and young women in the United States may have iron deficiency, which can lead to fatigue and increase the risk of many health problems, according to a new study. 

Researchers also found that 6 in every 100 of the girls and young women had extremely low iron levels, known as iron-deficiency anemia, which impacts the blood’s ability to carry oxygen throughout the body.

The findings suggest that current screening guidelines for iron levels in girls and women may be flawed, resulting in missed chances to get a simple blood test that can diagnose the easy-to-treat condition. Iron supplements are often prescribed as a treatment.

The study was published in JAMA and included 12 years of data for a total of nearly 3,500 girls and women aged 12-21 years.

In addition to shortness of breath and fatigue, other symptoms of iron deficiency anemia are: 

• Pale skin
• Cold hands and feet
• Feeling dizzy or lightheaded
• Unusual cravings for nonfood items such as ice, dirt, or paper.

The Cleveland Clinic says the most common causes of iron-deficiency anemia are those that involve blood loss, including heavy menstrual periods. The body gets iron from food, and not getting enough iron from food, as can happen from eating a vegan or vegetarian diet, can also lead to deficiency. 

In this latest study, researchers found that young women and girls’ likelihood to have iron deficiency or iron-deficiency anemia were significantly linked to race and ethnicity, poverty status, access to sufficient or quality food (also called food insecurity), and body mass index. Black and Hispanic girls and women were more likely to have iron level problems, compared with White girls and women. Black girls and women were four times more likely to have iron-deficiency anemia, compared with White girls and women.

The authors did not discuss potential causes and suggested further study is needed to identify risk factors of iron deficiency in girls and young women.

A version of this article originally appeared on WebMD.com.

Nearly 40% of girls and young women in the United States may have iron deficiency, which can lead to fatigue and increase the risk of many health problems, according to a new study. 

Researchers also found that 6 in every 100 of the girls and young women had extremely low iron levels, known as iron-deficiency anemia, which impacts the blood’s ability to carry oxygen throughout the body.

The findings suggest that current screening guidelines for iron levels in girls and women may be flawed, resulting in missed chances to get a simple blood test that can diagnose the easy-to-treat condition. Iron supplements are often prescribed as a treatment.

The study was published in JAMA and included 12 years of data for a total of nearly 3,500 girls and women aged 12-21 years.

In addition to shortness of breath and fatigue, other symptoms of iron deficiency anemia are: 

• Pale skin
• Cold hands and feet
• Feeling dizzy or lightheaded
• Unusual cravings for nonfood items such as ice, dirt, or paper.

The Cleveland Clinic says the most common causes of iron-deficiency anemia are those that involve blood loss, including heavy menstrual periods. The body gets iron from food, and not getting enough iron from food, as can happen from eating a vegan or vegetarian diet, can also lead to deficiency. 

In this latest study, researchers found that young women and girls’ likelihood to have iron deficiency or iron-deficiency anemia were significantly linked to race and ethnicity, poverty status, access to sufficient or quality food (also called food insecurity), and body mass index. Black and Hispanic girls and women were more likely to have iron level problems, compared with White girls and women. Black girls and women were four times more likely to have iron-deficiency anemia, compared with White girls and women.

The authors did not discuss potential causes and suggested further study is needed to identify risk factors of iron deficiency in girls and young women.

A version of this article originally appeared on WebMD.com.

Nearly 40% of girls and young women in the United States may have iron deficiency, which can lead to fatigue and increase the risk of many health problems, according to a new study. 

Researchers also found that 6 in every 100 of the girls and young women had extremely low iron levels, known as iron-deficiency anemia, which impacts the blood’s ability to carry oxygen throughout the body.

The findings suggest that current screening guidelines for iron levels in girls and women may be flawed, resulting in missed chances to get a simple blood test that can diagnose the easy-to-treat condition. Iron supplements are often prescribed as a treatment.

The study was published in JAMA and included 12 years of data for a total of nearly 3,500 girls and women aged 12-21 years.

In addition to shortness of breath and fatigue, other symptoms of iron deficiency anemia are: 

• Pale skin
• Cold hands and feet
• Feeling dizzy or lightheaded
• Unusual cravings for nonfood items such as ice, dirt, or paper.

The Cleveland Clinic says the most common causes of iron-deficiency anemia are those that involve blood loss, including heavy menstrual periods. The body gets iron from food, and not getting enough iron from food, as can happen from eating a vegan or vegetarian diet, can also lead to deficiency. 

In this latest study, researchers found that young women and girls’ likelihood to have iron deficiency or iron-deficiency anemia were significantly linked to race and ethnicity, poverty status, access to sufficient or quality food (also called food insecurity), and body mass index. Black and Hispanic girls and women were more likely to have iron level problems, compared with White girls and women. Black girls and women were four times more likely to have iron-deficiency anemia, compared with White girls and women.

The authors did not discuss potential causes and suggested further study is needed to identify risk factors of iron deficiency in girls and young women.

A version of this article originally appeared on WebMD.com.

A new framework from the American Academy of Pediatrics aims to aid general pediatricians in better caring for premature babies who are at risk of developing developmental disabilities.

About 1 in 10 babies in the United States are born before full term. Even when they are discharged from neonatal intensive care units (NICUs), these babies are still at risk for conditions like cerebral palsy, autism spectrum disorder, deafness, and severe hearing loss.

The framework, published in Pediatrics, consolidates existing research into a guide for busy pediatricians to categorize patients as very high risk, high risk, or moderate-low risk for neurodevelopmental disabilities. The guidance also lists key identifiers to help providers flag issues early, such as asymmetry of hand use.

Beth Ellen Davis, MD, MPH, a framework author, said the goal is to help pediatricians determine what surveillance and screening they can conduct to promote positive health outcomes.

Dr. Davis said she wished she had this guidance on caring for children who were born prematurely during her 10 years as a general pediatrician in the U.S. Army Medical Corps.

“I didn’t know what I was supposed to do differently with [the former NICU babies],” said Dr. Davis, a professor in the division of neurodevelopmental behavioral pediatrics at the University of Virginia, Charlottesville. 

For instance, babies born earlier than 28 weeks who have hypoxic ischemic encephalopathy or retinopathy of prematurity requiring surgery or intervention are classified as very high risk for the adverse outcomes, including intellectual disability.

The authors recommend follow-up and surveillance based on risk level at roughly 9-month intervals until around age 5. Each visit includes assessing for developmental milestones, like walking by 18 months or noting atypical pencil grasp at age 3.

Kendell German, MD, a neonatologist at University of Washington Medical Center, Seattle, and Seattle Children’s Hospital and a coauthor of the publication, said the tool will hopefully ensure that children are referred earlier to specialists.

“As neonatologists, we think about risk factors, but further out from birth, some of those things may be missed – particularly when we start thinking about kids who are transitioning in school and thinking about learning disabilities,” Dr. German said.

The guidance also outlines when pediatricians should – or should not – reassure families that an intellectual disability won’t develop. According to the authors, by age 3, the majority of children who have severe developmental disabilities will have been diagnosed.

“Some say you have to always keep suspicion out there for families of children who are born premature,” Dr. Davis said. “But we feel that after a period of time of monitoring and a child meeting their milestones, we can reassure parents that it is very unlikely their child will develop some of these severe developmental disabilities.”

Douglas Vanderbilt, MD, MS, chief of the developmental-behavioral pediatrics division and director of newborn and infant follow-up program at Children’s Hospital Los Angeles, said that general pediatricians and family practice clinicians may face barriers to implementation such as not having enough time to screen patients or difficulty collaborating with specialists.

But, “whatever we can do to articulate, educate, and facilitate a capacity within general pediatrics to improve training is a really good thing,” said Dr. Vanderbilt, who was not involved with the guidance.

The authors also highlighted lower-severity conditions that can result from prematurity, such as language and speech disorders, developmental coordination disorders, ADHD, and visual motor integration problems.

“Those of us in the medical field can be quite focused on the most severe disabilities that are possible,” said Andrea Duncan, MD, MSc, director of the neonatal follow-up program at the Children’s Hospital of Philadelphia, who was not associated with the report. But, “most of the disabilities we see in follow-up are more subtle or milder but can have a very significant impact on school function, participation, and the overall quality of a child’s life.

Dr. Duncan said the framework doesn’t entirely put the onus on primary care clinicians, but helps stratify risk and indicates when referrals to specialists may be appropriate.

“The importance of partnerships really comes through,” with specialties like neurology, audiology, and developmental behavioral pediatrics, Dr. Duncan said. “As long as those partnerships are made and families have access to services, implementation should be relatively easy.”

The authors of the report declared no relevant financial relationships. Dr. Vanderbilt is a consultant for a startup called Develo. He has no equity in the company.

A version of this article originally appeared on Medscape.com.

A new framework from the American Academy of Pediatrics aims to aid general pediatricians in better caring for premature babies who are at risk of developing developmental disabilities.

About 1 in 10 babies in the United States are born before full term. Even when they are discharged from neonatal intensive care units (NICUs), these babies are still at risk for conditions like cerebral palsy, autism spectrum disorder, deafness, and severe hearing loss.

The framework, published in Pediatrics, consolidates existing research into a guide for busy pediatricians to categorize patients as very high risk, high risk, or moderate-low risk for neurodevelopmental disabilities. The guidance also lists key identifiers to help providers flag issues early, such as asymmetry of hand use.

Beth Ellen Davis, MD, MPH, a framework author, said the goal is to help pediatricians determine what surveillance and screening they can conduct to promote positive health outcomes.

Dr. Davis said she wished she had this guidance on caring for children who were born prematurely during her 10 years as a general pediatrician in the U.S. Army Medical Corps.

“I didn’t know what I was supposed to do differently with [the former NICU babies],” said Dr. Davis, a professor in the division of neurodevelopmental behavioral pediatrics at the University of Virginia, Charlottesville. 

For instance, babies born earlier than 28 weeks who have hypoxic ischemic encephalopathy or retinopathy of prematurity requiring surgery or intervention are classified as very high risk for the adverse outcomes, including intellectual disability.

The authors recommend follow-up and surveillance based on risk level at roughly 9-month intervals until around age 5. Each visit includes assessing for developmental milestones, like walking by 18 months or noting atypical pencil grasp at age 3.

Kendell German, MD, a neonatologist at University of Washington Medical Center, Seattle, and Seattle Children’s Hospital and a coauthor of the publication, said the tool will hopefully ensure that children are referred earlier to specialists.

“As neonatologists, we think about risk factors, but further out from birth, some of those things may be missed – particularly when we start thinking about kids who are transitioning in school and thinking about learning disabilities,” Dr. German said.

The guidance also outlines when pediatricians should – or should not – reassure families that an intellectual disability won’t develop. According to the authors, by age 3, the majority of children who have severe developmental disabilities will have been diagnosed.

“Some say you have to always keep suspicion out there for families of children who are born premature,” Dr. Davis said. “But we feel that after a period of time of monitoring and a child meeting their milestones, we can reassure parents that it is very unlikely their child will develop some of these severe developmental disabilities.”

Douglas Vanderbilt, MD, MS, chief of the developmental-behavioral pediatrics division and director of newborn and infant follow-up program at Children’s Hospital Los Angeles, said that general pediatricians and family practice clinicians may face barriers to implementation such as not having enough time to screen patients or difficulty collaborating with specialists.

But, “whatever we can do to articulate, educate, and facilitate a capacity within general pediatrics to improve training is a really good thing,” said Dr. Vanderbilt, who was not involved with the guidance.

The authors also highlighted lower-severity conditions that can result from prematurity, such as language and speech disorders, developmental coordination disorders, ADHD, and visual motor integration problems.

“Those of us in the medical field can be quite focused on the most severe disabilities that are possible,” said Andrea Duncan, MD, MSc, director of the neonatal follow-up program at the Children’s Hospital of Philadelphia, who was not associated with the report. But, “most of the disabilities we see in follow-up are more subtle or milder but can have a very significant impact on school function, participation, and the overall quality of a child’s life.

Dr. Duncan said the framework doesn’t entirely put the onus on primary care clinicians, but helps stratify risk and indicates when referrals to specialists may be appropriate.

“The importance of partnerships really comes through,” with specialties like neurology, audiology, and developmental behavioral pediatrics, Dr. Duncan said. “As long as those partnerships are made and families have access to services, implementation should be relatively easy.”

The authors of the report declared no relevant financial relationships. Dr. Vanderbilt is a consultant for a startup called Develo. He has no equity in the company.

A version of this article originally appeared on Medscape.com.

A new framework from the American Academy of Pediatrics aims to aid general pediatricians in better caring for premature babies who are at risk of developing developmental disabilities.

About 1 in 10 babies in the United States are born before full term. Even when they are discharged from neonatal intensive care units (NICUs), these babies are still at risk for conditions like cerebral palsy, autism spectrum disorder, deafness, and severe hearing loss.

The framework, published in Pediatrics, consolidates existing research into a guide for busy pediatricians to categorize patients as very high risk, high risk, or moderate-low risk for neurodevelopmental disabilities. The guidance also lists key identifiers to help providers flag issues early, such as asymmetry of hand use.

Beth Ellen Davis, MD, MPH, a framework author, said the goal is to help pediatricians determine what surveillance and screening they can conduct to promote positive health outcomes.

Dr. Davis said she wished she had this guidance on caring for children who were born prematurely during her 10 years as a general pediatrician in the U.S. Army Medical Corps.

“I didn’t know what I was supposed to do differently with [the former NICU babies],” said Dr. Davis, a professor in the division of neurodevelopmental behavioral pediatrics at the University of Virginia, Charlottesville. 

For instance, babies born earlier than 28 weeks who have hypoxic ischemic encephalopathy or retinopathy of prematurity requiring surgery or intervention are classified as very high risk for the adverse outcomes, including intellectual disability.

The authors recommend follow-up and surveillance based on risk level at roughly 9-month intervals until around age 5. Each visit includes assessing for developmental milestones, like walking by 18 months or noting atypical pencil grasp at age 3.

Kendell German, MD, a neonatologist at University of Washington Medical Center, Seattle, and Seattle Children’s Hospital and a coauthor of the publication, said the tool will hopefully ensure that children are referred earlier to specialists.

“As neonatologists, we think about risk factors, but further out from birth, some of those things may be missed – particularly when we start thinking about kids who are transitioning in school and thinking about learning disabilities,” Dr. German said.

The guidance also outlines when pediatricians should – or should not – reassure families that an intellectual disability won’t develop. According to the authors, by age 3, the majority of children who have severe developmental disabilities will have been diagnosed.

“Some say you have to always keep suspicion out there for families of children who are born premature,” Dr. Davis said. “But we feel that after a period of time of monitoring and a child meeting their milestones, we can reassure parents that it is very unlikely their child will develop some of these severe developmental disabilities.”

Douglas Vanderbilt, MD, MS, chief of the developmental-behavioral pediatrics division and director of newborn and infant follow-up program at Children’s Hospital Los Angeles, said that general pediatricians and family practice clinicians may face barriers to implementation such as not having enough time to screen patients or difficulty collaborating with specialists.

But, “whatever we can do to articulate, educate, and facilitate a capacity within general pediatrics to improve training is a really good thing,” said Dr. Vanderbilt, who was not involved with the guidance.

The authors also highlighted lower-severity conditions that can result from prematurity, such as language and speech disorders, developmental coordination disorders, ADHD, and visual motor integration problems.

“Those of us in the medical field can be quite focused on the most severe disabilities that are possible,” said Andrea Duncan, MD, MSc, director of the neonatal follow-up program at the Children’s Hospital of Philadelphia, who was not associated with the report. But, “most of the disabilities we see in follow-up are more subtle or milder but can have a very significant impact on school function, participation, and the overall quality of a child’s life.

Dr. Duncan said the framework doesn’t entirely put the onus on primary care clinicians, but helps stratify risk and indicates when referrals to specialists may be appropriate.

“The importance of partnerships really comes through,” with specialties like neurology, audiology, and developmental behavioral pediatrics, Dr. Duncan said. “As long as those partnerships are made and families have access to services, implementation should be relatively easy.”

The authors of the report declared no relevant financial relationships. Dr. Vanderbilt is a consultant for a startup called Develo. He has no equity in the company.

A version of this article originally appeared on Medscape.com.

Amelia Kennedy, 19, of Royersford, Pa., a point guard on the Catholic University of America, Washington, basketball team who will begin her sophomore year in the fall, uses TikTok, Snapchat, Instagram, and YouTube regularly.

How regularly? She estimates 7 hours a day and about 9 on weekends. She’s aware of the time-wasting potential. “If my mom says, ‘Do dishes,’ and I say, ‘5 more minutes,’ it can be longer,’’ she said.

Now imagine the challenge of cutting that 7 or 9 hours a day of social media use down to 30 minutes.

A very tall order, considering a 2022 Pew Research Center survey of more than 1,300 teens found 35% are “nearly constantly” on at least one of the top five social media platforms: YouTube, TikTok, Instagram, Snapchat, and Facebook.

Researchers from Iowa State University, Ames, recently took on that daunting challenge, limiting a group of students to only 30 minutes of social media a day to see what happens. Two weeks into the study, the students reported improvement in psychological well-being and other important measures, including sleep quality, compared with a control group assigned to continue using social media as usual.

And the dreaded FOMO, or fear of missing out, didn’t happen, the researchers said. At the end, the students were rethinking their social media use and feeling positive about it.

As social media becomes more common and youth mental health more endangered, experts are sounding the alarm. In late May, U.S. Surgeon General Vivek Murthy, MD, issued an advisory on social media and youth mental health, calling for tech companies to do better, policymakers to strengthen safety, and researchers to get more information, among other actions.

After that, the Biden administration took actions including the launch of a task force on kids’ online health and safety. The American Psychological Association has issued recommendations on social media use in youths. And the Social Media Victims Law Center in Seattle has sued numerous social media companies for online activity resulting in death and other tragedies.

While experts acknowledge that much more research is needed to sort out how to balance social media’s risks and benefits to preserve youth mental health and prevent such disasters, the new Iowa State study, as well as other recent research, suggests that youths are aware of the dangers of social media and, given some guidance and information, can monitor themselves and limit their screen time to preserve mental health.
 

Goal: 30 minutes a day

In the Iowa State study, 230 undergraduate students were assigned to one of two groups, with 99 in the 30-minute-a-day social media use group and 131 in the “usual” or control group, which made no changes. For those in the intervention group, “we sent a daily reminder email,” said Ella Faulhaber, a PhD candidate at Iowa State and the study’s lead author. It simply reminded them to limit social medial use to the 30-minute maximum.

At the study start and end, all participants provided a screenshot of their weekly social media usage time. The researchers gave both groups a battery of tests to assess anxiety, depression, loneliness, fear of missing out, and negative and positive feelings.

“By limiting their social media time, that resulted in less anxiety, less depression, less FOMO, fewer negative emotions, and greater positive emotions,” said Douglas Gentile, PhD, a distinguished professor of psychology at Iowa State and a study coauthor. “We know that it is the limiting [of] the social media that is causing that.”

Ms. Faulhaber recalled one participant who mentioned having trouble at first adjusting to the 30-minute time frame, but once sleep improved, it was easier to stick to that guidance. Another who gave up phone use at bedtime found: “Instead of looking at my phone, it was much easier to go straight to bed.”

Sleep improvements, of course, affect many parts of physical and mental health, Dr. Gentile said. And the study also showed that even with reduced screen time, “we can still get the benefit of being connected.” Those who didn’t make the 30-minute mark, but cut back, got benefits, too, the researchers said.
 

‘Youth are aware’

Self-monitoring works, agreed Jane Harness, DO, an adjunct clinical assistant professor of psychiatry at the University of Michigan, Ann Arbor, because “having that insight is often the first step.”

In a study she conducted, Dr. Harness aimed to gather youths’ insights about how their social media use affected them. With her colleagues, she asked more than 1,100 youths, aged 14-24, what advice they would give to those new to social media, if they ever felt they needed to change social media habits, and if they have deleted or considered deleting social media accounts.

From the 871 responses, Harness found that youths were especially concerned about safety online, that most had thought about deleting a social media app and some had, and that youths were more likely to say they wanted to change the amount of time spent on social media, compared with the content they view.

“Users responded with great advice for each other,” she said. “Safety was brought up,” with users reminding others to keep accounts private and to be aware of location tracking links and content that seems to promote eating disorders, suicide, and other harms.

In the study report, Dr. Harness concluded: “Youth are aware of ways in which social media could be negatively impacting them and they have employed methods to modulate their use because of this awareness.”
 

Less FOMO, less anxiety

In an earlier study, University of Pennsylvania, Philadelphia, researchers had 143 college students self-monitor social media for a week, then randomly assigned them either to a group told to limit Facebook, Instagram, and Snapchat use to 10 minutes per platform, per day, or to a group told to use social media as usual for 3 weeks.

At the end of the study, the researchers evaluated both groups and found “significant reductions in loneliness and depression over 3 weeks’’ in the limited-use group, compared with the usual-use group, according to study researcher Melissa G. Hunt, PhD, associate director of clinical training at the University of Pennsylvania.

And both groups showed declines in anxiety and fear of missing out, suggesting a benefit tied to self-monitoring itself, she said.

While Dr. Hunt’s study focused on 30 minutes a day, she said “about an hour a day seems to be the sweet spot for maximizing the positive effects of connecting, but limiting the negative effects of social media use.”

She also suggested that smartphones have no place in middle or high school classrooms. Instead, they should be on lockdown during classes.

“Parents need to set real limits of cellphone use during meals and in bedrooms,” Dr. Hunt said. At mealtime, for instance, all phones should be absent from the table. And after 10 p.m., “all family phones remain in the kitchen.”
 

Be ‘more mindful’

These recent study findings about self-monitoring and limiting social media time may not work the same for everyone, especially among those who aren’t as motivated, said psychiatrist Elizabeth Ortiz-Schwartz, MD, team lead for the adolescent inpatient unit at Silver Hill Hospital in New Canaan, Conn.

But “the bigger take-home piece is that being intentional and attempting to decrease the use in these individuals, even if they were not always successful, was clearly beneficial,” she said.

As we await clearer guidelines about what is the “right” amount of use in terms of social media content and time, Dr. Ortiz-Schwartz said, “becoming more mindful and aware of the risks and benefits can hopefully help individuals become more mindful and deliberate about its use.”
 

Real-world strategies

Max Schwandt, 23, is an outlier, but a happy one. He works as a sales clerk at a Los Angeles–area recreational gear shop, and he uses no social media. Why not? “It takes up too much time,” he explained. As simple as that.

But for many other teens and young adults, the struggle to stay off social media is real.

Amelia Kennedy, the Catholic University of America student, is trying to reduce her screen time. One way is to track it on her phone. These days, her summer job at a restaurant serving breakfast gets her up early. “If I have to work, I still go on my phone, but not that long.” And once at work, she only has time for quick checks between work responsibilities. “I definitely am more productive,” she said about days when she has work.

Last December, Lauren Young, 25, whose father was a researcher on the Iowa State study, was finishing law school at Georgetown University, Washington, and decided to take a break from social media for the entire month. “I can’t say I was always successful in avoiding it,” she said. But cutting down greatly “made me a lot more present in my day-to-day life, and it was easier to concentrate.”

She could even get through a meal, out with friends, without her phone, keeping it in her purse. That was a definite change from the norm. “I noticed I would go out to dinner and the standard for people my age is having the phone on the table. If you are being polite, you turn it over.”

During her social media “blackout,” Ms. Young had deleted TikTok, Instagram, and Facebook apps. Then, when she graduated, she had to reinstall to post a picture. But now, she is back to minimal social media use.

“I’m studying for the bar, so it’s kind of necessary, but it always makes me happier.” She figures she can always text family and friends if necessary, instead of posting. “I felt for a while I was missing out on things, but not now,” she said.

Others, including Sarah Goldstein, 22, of Chatsworth, Calif., a supermarket courtesy clerk who is thinking of returning to college, said she has developed a healthier attitude toward social media as she has gotten older.

“In middle and early high school, I would see parties, things I wasn’t invited to, on Snapchat and Instagram.” While she realized there could be legitimate reasons for not being included, she said it was easy to internalize those feelings of being left out.

These days, she said she doesn’t let it affect her mental health that way. She enjoys social media – especially TikTok and Instagram – for its benefits. “It kills time, gives you something to watch, can make you laugh and feel like you have a connection with other people.”

A version of this article first appeared on WebMD.com.

Amelia Kennedy, 19, of Royersford, Pa., a point guard on the Catholic University of America, Washington, basketball team who will begin her sophomore year in the fall, uses TikTok, Snapchat, Instagram, and YouTube regularly.

How regularly? She estimates 7 hours a day and about 9 on weekends. She’s aware of the time-wasting potential. “If my mom says, ‘Do dishes,’ and I say, ‘5 more minutes,’ it can be longer,’’ she said.

Now imagine the challenge of cutting that 7 or 9 hours a day of social media use down to 30 minutes.

A very tall order, considering a 2022 Pew Research Center survey of more than 1,300 teens found 35% are “nearly constantly” on at least one of the top five social media platforms: YouTube, TikTok, Instagram, Snapchat, and Facebook.

Researchers from Iowa State University, Ames, recently took on that daunting challenge, limiting a group of students to only 30 minutes of social media a day to see what happens. Two weeks into the study, the students reported improvement in psychological well-being and other important measures, including sleep quality, compared with a control group assigned to continue using social media as usual.

And the dreaded FOMO, or fear of missing out, didn’t happen, the researchers said. At the end, the students were rethinking their social media use and feeling positive about it.

As social media becomes more common and youth mental health more endangered, experts are sounding the alarm. In late May, U.S. Surgeon General Vivek Murthy, MD, issued an advisory on social media and youth mental health, calling for tech companies to do better, policymakers to strengthen safety, and researchers to get more information, among other actions.

After that, the Biden administration took actions including the launch of a task force on kids’ online health and safety. The American Psychological Association has issued recommendations on social media use in youths. And the Social Media Victims Law Center in Seattle has sued numerous social media companies for online activity resulting in death and other tragedies.

While experts acknowledge that much more research is needed to sort out how to balance social media’s risks and benefits to preserve youth mental health and prevent such disasters, the new Iowa State study, as well as other recent research, suggests that youths are aware of the dangers of social media and, given some guidance and information, can monitor themselves and limit their screen time to preserve mental health.
 

Goal: 30 minutes a day

In the Iowa State study, 230 undergraduate students were assigned to one of two groups, with 99 in the 30-minute-a-day social media use group and 131 in the “usual” or control group, which made no changes. For those in the intervention group, “we sent a daily reminder email,” said Ella Faulhaber, a PhD candidate at Iowa State and the study’s lead author. It simply reminded them to limit social medial use to the 30-minute maximum.

At the study start and end, all participants provided a screenshot of their weekly social media usage time. The researchers gave both groups a battery of tests to assess anxiety, depression, loneliness, fear of missing out, and negative and positive feelings.

“By limiting their social media time, that resulted in less anxiety, less depression, less FOMO, fewer negative emotions, and greater positive emotions,” said Douglas Gentile, PhD, a distinguished professor of psychology at Iowa State and a study coauthor. “We know that it is the limiting [of] the social media that is causing that.”

Ms. Faulhaber recalled one participant who mentioned having trouble at first adjusting to the 30-minute time frame, but once sleep improved, it was easier to stick to that guidance. Another who gave up phone use at bedtime found: “Instead of looking at my phone, it was much easier to go straight to bed.”

Sleep improvements, of course, affect many parts of physical and mental health, Dr. Gentile said. And the study also showed that even with reduced screen time, “we can still get the benefit of being connected.” Those who didn’t make the 30-minute mark, but cut back, got benefits, too, the researchers said.
 

‘Youth are aware’

Self-monitoring works, agreed Jane Harness, DO, an adjunct clinical assistant professor of psychiatry at the University of Michigan, Ann Arbor, because “having that insight is often the first step.”

In a study she conducted, Dr. Harness aimed to gather youths’ insights about how their social media use affected them. With her colleagues, she asked more than 1,100 youths, aged 14-24, what advice they would give to those new to social media, if they ever felt they needed to change social media habits, and if they have deleted or considered deleting social media accounts.

From the 871 responses, Harness found that youths were especially concerned about safety online, that most had thought about deleting a social media app and some had, and that youths were more likely to say they wanted to change the amount of time spent on social media, compared with the content they view.

“Users responded with great advice for each other,” she said. “Safety was brought up,” with users reminding others to keep accounts private and to be aware of location tracking links and content that seems to promote eating disorders, suicide, and other harms.

In the study report, Dr. Harness concluded: “Youth are aware of ways in which social media could be negatively impacting them and they have employed methods to modulate their use because of this awareness.”
 

Less FOMO, less anxiety

In an earlier study, University of Pennsylvania, Philadelphia, researchers had 143 college students self-monitor social media for a week, then randomly assigned them either to a group told to limit Facebook, Instagram, and Snapchat use to 10 minutes per platform, per day, or to a group told to use social media as usual for 3 weeks.

At the end of the study, the researchers evaluated both groups and found “significant reductions in loneliness and depression over 3 weeks’’ in the limited-use group, compared with the usual-use group, according to study researcher Melissa G. Hunt, PhD, associate director of clinical training at the University of Pennsylvania.

And both groups showed declines in anxiety and fear of missing out, suggesting a benefit tied to self-monitoring itself, she said.

While Dr. Hunt’s study focused on 30 minutes a day, she said “about an hour a day seems to be the sweet spot for maximizing the positive effects of connecting, but limiting the negative effects of social media use.”

She also suggested that smartphones have no place in middle or high school classrooms. Instead, they should be on lockdown during classes.

“Parents need to set real limits of cellphone use during meals and in bedrooms,” Dr. Hunt said. At mealtime, for instance, all phones should be absent from the table. And after 10 p.m., “all family phones remain in the kitchen.”
 

Be ‘more mindful’

These recent study findings about self-monitoring and limiting social media time may not work the same for everyone, especially among those who aren’t as motivated, said psychiatrist Elizabeth Ortiz-Schwartz, MD, team lead for the adolescent inpatient unit at Silver Hill Hospital in New Canaan, Conn.

But “the bigger take-home piece is that being intentional and attempting to decrease the use in these individuals, even if they were not always successful, was clearly beneficial,” she said.

As we await clearer guidelines about what is the “right” amount of use in terms of social media content and time, Dr. Ortiz-Schwartz said, “becoming more mindful and aware of the risks and benefits can hopefully help individuals become more mindful and deliberate about its use.”
 

Real-world strategies

Max Schwandt, 23, is an outlier, but a happy one. He works as a sales clerk at a Los Angeles–area recreational gear shop, and he uses no social media. Why not? “It takes up too much time,” he explained. As simple as that.

But for many other teens and young adults, the struggle to stay off social media is real.

Amelia Kennedy, the Catholic University of America student, is trying to reduce her screen time. One way is to track it on her phone. These days, her summer job at a restaurant serving breakfast gets her up early. “If I have to work, I still go on my phone, but not that long.” And once at work, she only has time for quick checks between work responsibilities. “I definitely am more productive,” she said about days when she has work.

Last December, Lauren Young, 25, whose father was a researcher on the Iowa State study, was finishing law school at Georgetown University, Washington, and decided to take a break from social media for the entire month. “I can’t say I was always successful in avoiding it,” she said. But cutting down greatly “made me a lot more present in my day-to-day life, and it was easier to concentrate.”

She could even get through a meal, out with friends, without her phone, keeping it in her purse. That was a definite change from the norm. “I noticed I would go out to dinner and the standard for people my age is having the phone on the table. If you are being polite, you turn it over.”

During her social media “blackout,” Ms. Young had deleted TikTok, Instagram, and Facebook apps. Then, when she graduated, she had to reinstall to post a picture. But now, she is back to minimal social media use.

“I’m studying for the bar, so it’s kind of necessary, but it always makes me happier.” She figures she can always text family and friends if necessary, instead of posting. “I felt for a while I was missing out on things, but not now,” she said.

Others, including Sarah Goldstein, 22, of Chatsworth, Calif., a supermarket courtesy clerk who is thinking of returning to college, said she has developed a healthier attitude toward social media as she has gotten older.

“In middle and early high school, I would see parties, things I wasn’t invited to, on Snapchat and Instagram.” While she realized there could be legitimate reasons for not being included, she said it was easy to internalize those feelings of being left out.

These days, she said she doesn’t let it affect her mental health that way. She enjoys social media – especially TikTok and Instagram – for its benefits. “It kills time, gives you something to watch, can make you laugh and feel like you have a connection with other people.”

A version of this article first appeared on WebMD.com.

Amelia Kennedy, 19, of Royersford, Pa., a point guard on the Catholic University of America, Washington, basketball team who will begin her sophomore year in the fall, uses TikTok, Snapchat, Instagram, and YouTube regularly.

How regularly? She estimates 7 hours a day and about 9 on weekends. She’s aware of the time-wasting potential. “If my mom says, ‘Do dishes,’ and I say, ‘5 more minutes,’ it can be longer,’’ she said.

Now imagine the challenge of cutting that 7 or 9 hours a day of social media use down to 30 minutes.

A very tall order, considering a 2022 Pew Research Center survey of more than 1,300 teens found 35% are “nearly constantly” on at least one of the top five social media platforms: YouTube, TikTok, Instagram, Snapchat, and Facebook.

Researchers from Iowa State University, Ames, recently took on that daunting challenge, limiting a group of students to only 30 minutes of social media a day to see what happens. Two weeks into the study, the students reported improvement in psychological well-being and other important measures, including sleep quality, compared with a control group assigned to continue using social media as usual.

And the dreaded FOMO, or fear of missing out, didn’t happen, the researchers said. At the end, the students were rethinking their social media use and feeling positive about it.

As social media becomes more common and youth mental health more endangered, experts are sounding the alarm. In late May, U.S. Surgeon General Vivek Murthy, MD, issued an advisory on social media and youth mental health, calling for tech companies to do better, policymakers to strengthen safety, and researchers to get more information, among other actions.

After that, the Biden administration took actions including the launch of a task force on kids’ online health and safety. The American Psychological Association has issued recommendations on social media use in youths. And the Social Media Victims Law Center in Seattle has sued numerous social media companies for online activity resulting in death and other tragedies.

While experts acknowledge that much more research is needed to sort out how to balance social media’s risks and benefits to preserve youth mental health and prevent such disasters, the new Iowa State study, as well as other recent research, suggests that youths are aware of the dangers of social media and, given some guidance and information, can monitor themselves and limit their screen time to preserve mental health.
 

Goal: 30 minutes a day

In the Iowa State study, 230 undergraduate students were assigned to one of two groups, with 99 in the 30-minute-a-day social media use group and 131 in the “usual” or control group, which made no changes. For those in the intervention group, “we sent a daily reminder email,” said Ella Faulhaber, a PhD candidate at Iowa State and the study’s lead author. It simply reminded them to limit social medial use to the 30-minute maximum.

At the study start and end, all participants provided a screenshot of their weekly social media usage time. The researchers gave both groups a battery of tests to assess anxiety, depression, loneliness, fear of missing out, and negative and positive feelings.

“By limiting their social media time, that resulted in less anxiety, less depression, less FOMO, fewer negative emotions, and greater positive emotions,” said Douglas Gentile, PhD, a distinguished professor of psychology at Iowa State and a study coauthor. “We know that it is the limiting [of] the social media that is causing that.”

Ms. Faulhaber recalled one participant who mentioned having trouble at first adjusting to the 30-minute time frame, but once sleep improved, it was easier to stick to that guidance. Another who gave up phone use at bedtime found: “Instead of looking at my phone, it was much easier to go straight to bed.”

Sleep improvements, of course, affect many parts of physical and mental health, Dr. Gentile said. And the study also showed that even with reduced screen time, “we can still get the benefit of being connected.” Those who didn’t make the 30-minute mark, but cut back, got benefits, too, the researchers said.
 

‘Youth are aware’

Self-monitoring works, agreed Jane Harness, DO, an adjunct clinical assistant professor of psychiatry at the University of Michigan, Ann Arbor, because “having that insight is often the first step.”

In a study she conducted, Dr. Harness aimed to gather youths’ insights about how their social media use affected them. With her colleagues, she asked more than 1,100 youths, aged 14-24, what advice they would give to those new to social media, if they ever felt they needed to change social media habits, and if they have deleted or considered deleting social media accounts.

From the 871 responses, Harness found that youths were especially concerned about safety online, that most had thought about deleting a social media app and some had, and that youths were more likely to say they wanted to change the amount of time spent on social media, compared with the content they view.

“Users responded with great advice for each other,” she said. “Safety was brought up,” with users reminding others to keep accounts private and to be aware of location tracking links and content that seems to promote eating disorders, suicide, and other harms.

In the study report, Dr. Harness concluded: “Youth are aware of ways in which social media could be negatively impacting them and they have employed methods to modulate their use because of this awareness.”
 

Less FOMO, less anxiety

In an earlier study, University of Pennsylvania, Philadelphia, researchers had 143 college students self-monitor social media for a week, then randomly assigned them either to a group told to limit Facebook, Instagram, and Snapchat use to 10 minutes per platform, per day, or to a group told to use social media as usual for 3 weeks.

At the end of the study, the researchers evaluated both groups and found “significant reductions in loneliness and depression over 3 weeks’’ in the limited-use group, compared with the usual-use group, according to study researcher Melissa G. Hunt, PhD, associate director of clinical training at the University of Pennsylvania.

And both groups showed declines in anxiety and fear of missing out, suggesting a benefit tied to self-monitoring itself, she said.

While Dr. Hunt’s study focused on 30 minutes a day, she said “about an hour a day seems to be the sweet spot for maximizing the positive effects of connecting, but limiting the negative effects of social media use.”

She also suggested that smartphones have no place in middle or high school classrooms. Instead, they should be on lockdown during classes.

“Parents need to set real limits of cellphone use during meals and in bedrooms,” Dr. Hunt said. At mealtime, for instance, all phones should be absent from the table. And after 10 p.m., “all family phones remain in the kitchen.”
 

Be ‘more mindful’

These recent study findings about self-monitoring and limiting social media time may not work the same for everyone, especially among those who aren’t as motivated, said psychiatrist Elizabeth Ortiz-Schwartz, MD, team lead for the adolescent inpatient unit at Silver Hill Hospital in New Canaan, Conn.

But “the bigger take-home piece is that being intentional and attempting to decrease the use in these individuals, even if they were not always successful, was clearly beneficial,” she said.

As we await clearer guidelines about what is the “right” amount of use in terms of social media content and time, Dr. Ortiz-Schwartz said, “becoming more mindful and aware of the risks and benefits can hopefully help individuals become more mindful and deliberate about its use.”
 

Real-world strategies

Max Schwandt, 23, is an outlier, but a happy one. He works as a sales clerk at a Los Angeles–area recreational gear shop, and he uses no social media. Why not? “It takes up too much time,” he explained. As simple as that.

But for many other teens and young adults, the struggle to stay off social media is real.

Amelia Kennedy, the Catholic University of America student, is trying to reduce her screen time. One way is to track it on her phone. These days, her summer job at a restaurant serving breakfast gets her up early. “If I have to work, I still go on my phone, but not that long.” And once at work, she only has time for quick checks between work responsibilities. “I definitely am more productive,” she said about days when she has work.

Last December, Lauren Young, 25, whose father was a researcher on the Iowa State study, was finishing law school at Georgetown University, Washington, and decided to take a break from social media for the entire month. “I can’t say I was always successful in avoiding it,” she said. But cutting down greatly “made me a lot more present in my day-to-day life, and it was easier to concentrate.”

She could even get through a meal, out with friends, without her phone, keeping it in her purse. That was a definite change from the norm. “I noticed I would go out to dinner and the standard for people my age is having the phone on the table. If you are being polite, you turn it over.”

During her social media “blackout,” Ms. Young had deleted TikTok, Instagram, and Facebook apps. Then, when she graduated, she had to reinstall to post a picture. But now, she is back to minimal social media use.

“I’m studying for the bar, so it’s kind of necessary, but it always makes me happier.” She figures she can always text family and friends if necessary, instead of posting. “I felt for a while I was missing out on things, but not now,” she said.

Others, including Sarah Goldstein, 22, of Chatsworth, Calif., a supermarket courtesy clerk who is thinking of returning to college, said she has developed a healthier attitude toward social media as she has gotten older.

“In middle and early high school, I would see parties, things I wasn’t invited to, on Snapchat and Instagram.” While she realized there could be legitimate reasons for not being included, she said it was easy to internalize those feelings of being left out.

These days, she said she doesn’t let it affect her mental health that way. She enjoys social media – especially TikTok and Instagram – for its benefits. “It kills time, gives you something to watch, can make you laugh and feel like you have a connection with other people.”

A version of this article first appeared on WebMD.com.

The human papillomavirus (HPV) vaccine may now be as critical as ever, though young people are taking the shot in fewer and fewer numbers. An epidemic of sexually transmitted HPV is now swirling around the United States and the United Kingdom, with some serious cases leading to oropharyngeal cancer, which can affect the back of the throat, tonsils, and tongue.

HPV is the leading cause (70%) of this oropharyngeal cancer, according to the CDC. It is the most common sexually transmitted disease in the nation, and around 3.6% of women and 10% of men report oral HPV specifically. But over the past decade, oropharyngeal cases have been steadily falling a little under 4% and 2%, respectively, according to the National Cancer Institute.

HPV is often undetectable and can clear up within a few months. But unfortunately for some, serious disease, such as throat cancer, can develop. 

Studies show the HPV vaccine to be extremely effective in lowering sexually transmitted HPV cases. Yet, only 54.5% of young people aged 13-15 have taken the recommended two to three doses, according to the National Cancer Institute. 
 

Why aren’t more young people taking the vaccine? 

Low public awareness of the dangers of HPV may be behind young people’s poor vaccination rates, according to Teresa Lee, MD, of the Fox Chase Cancer Center in Philadelphia. “For example, while the link with head and neck cancers has been well-studied, the FDA labeling was not changed to reflect this as an indication until 2020,” she said.

Other reasons can include one’s socioeconomic background, poor health literacy, cultural or religious stigmas around vaccines, and lack of quality, low-cost health care, says Emmanuel Aguh, MD, a board-certified family medicine physician. “Some individuals and families are still resistant to vaccines and the noted lack of uptake.”

Doctors and other health care professionals should also be sure to tell patients of all ages about the risks of HPV infection and how well the vaccine works, Dr. Lee said. “Not everyone who is now eligible may have been offered the vaccine as a child, and the first time young adults may receive counseling on this subject may not be until they are entering a very busy period of their lives with many responsibilities – when it may be hard to fit in things like health maintenance.”
 

How safe is the HPV vaccine?

The Food and Drug Administration and Centers for Disease Control and Prevention have studied the HPV vaccine for years to find out how safe it is and how well it works, Dr. Aguh said. No major side effects have been reported, and the most common side effect is soreness where you get the shot (which is normal after most vaccines). Some dizziness and fainting in adolescents can also occur, so young people are usually asked to sit or lie down during the shot and for 15 minutes afterward, he said. 

“Serious adverse events have not been reported at higher rates than expected following HPV vaccination, meaning there is no clear evidence they are related to the vaccine,” Dr. Lee said. “The vaccine is highly effective in decreasing rates of detectable infection with the high-risk HPV strains responsible for HPV-associated cancers.”

The HPV vaccine is largely recommended for people aged 9-26, and sometimes up to age 45, depending on the individual, Dr. Aguh said. If you are over 26, talk to your doctor about whether you should consider getting the vaccine.

“It is usually given in two doses for complete protection if taken before the 15th birthday,” Dr. Aguh said. “If taken afterward, or in those with a weak immune system, they might require three doses to be fully protected.”

The vaccine produces antibodies that can stop HPV from infecting cells and lowers your chances of catching an HPV-related cancer, such as throat cancer or cancer of the cervix, he said.

While the vaccine is not guaranteed to protect you from the more than 100 strains of HPV, it can protect you from HPV 16 and HPV 18 – two high-risk strains that cause around 70% of cervical cancers. 
 

What is fueling the rise of HPV cases? 

A misconception that oral sex is somehow a “safe and risk-free” alternative to anal or vaginal sex could be one reason, Dr. Aguh said.

“It is important to know that, with oral sex, you are exposed to many of the risks associated with vaginal intercourse, especially if you do not take any measures to protect yourself and/or your partner,” Dr. Aguh said. “[With oral sex] it is possible to end up contracting an infection like chlamydia, gonorrhea, and even HPV, leading to an increased risk of HPV-associated oropharyngeal cancers.”

A lack of public awareness of what can cause throat cancer could also explain this phenomenon. The number of people you have oral sex with, along with the age you begin sexual activity, can greatly determine your risk of the disease, according to Dr. Lee. She echoes a report by Hisham Mehanna, PhD, in The Conversation.

“For oropharyngeal cancer, the main risk factor is the number of lifetime sexual partners, especially oral sex,” wrote Dr. Mehanna, a professor at the Institute of Cancer and Genomic Sciences at the University of Birmingham (England). “Those with six or more lifetime oral-sex partners are 8.5 times more likely to develop oropharyngeal cancer than those who do not practice oral sex.”
 

What are symptoms of oropharyngeal cancer?

Labored breathing or swallowing, a cough that won’t go away, and crackling or hoarseness of your voice could all be signs of throat cancer. Other symptoms include earaches, swelling of the head or neck, and enlarged lymph nodes, among others, Dr. Aguh said.

“The signs and symptoms of HPV-related throat cancers can be difficult to identify and recognize, as they can be vague and are also associated with other medical conditions. Sometimes, there are no signs at all, or they are not easily noticeable due to the location,” he said. 

You should go see your doctor if you have any of these ailments for an extended period.
 

How to reduce your risk

In addition to having six or more oral-sex partners, smoking and drinking heavily could also raise your risk of throat cancer, said Dr. Lee. Proper dental health – like seeing your dentist regularly and practicing proper oral hygiene – can also shave your risk.

“[Good dental health] can help not just with head and neck cancer risk, but with many other inflammation-related diseases,” Dr. Lee said. 

Using dental dams and condoms can also be a good method of protection, Dr. Aguh said. A dental dam is a stretchy sheet of latex, or polyurethane plastic, in the shape of a square that is made for blocking body fluid to lower your risk of contracting an STD via oral sex. 

Keep in mind: Even with these protections, make sure you and your partner discuss each other’s sexual history, any prior or current STDs and their preferred protection from STDs, said Dr. Aguh.

If you or your partner is being treated for an STD, consider opting out of oral sex and consulting a doctor.

The HPV vaccine is another common method of protection. The shot is “approved for prevention of nine of the most high-risk strains of HPV,” or those that are most commonly linked to cancer, according to Dr. Lee. The vaccine “reduces the frequency of infection” with these viruses, which can ultimately lower the risk of cancers linked to HPV, including cervical, anal, and vulvar and vaginal cancers, she said.

“The best time to receive treatment for prevention of disease is prior to onset of sexual intercourse,” said Dr. Lee.  

To get your HPV vaccine, head to your family doctor, school- or community-based health center, or state health department, suggests the CDC.

A version of this article originally appeared on WebMD.com.

The human papillomavirus (HPV) vaccine may now be as critical as ever, though young people are taking the shot in fewer and fewer numbers. An epidemic of sexually transmitted HPV is now swirling around the United States and the United Kingdom, with some serious cases leading to oropharyngeal cancer, which can affect the back of the throat, tonsils, and tongue.

HPV is the leading cause (70%) of this oropharyngeal cancer, according to the CDC. It is the most common sexually transmitted disease in the nation, and around 3.6% of women and 10% of men report oral HPV specifically. But over the past decade, oropharyngeal cases have been steadily falling a little under 4% and 2%, respectively, according to the National Cancer Institute.

HPV is often undetectable and can clear up within a few months. But unfortunately for some, serious disease, such as throat cancer, can develop. 

Studies show the HPV vaccine to be extremely effective in lowering sexually transmitted HPV cases. Yet, only 54.5% of young people aged 13-15 have taken the recommended two to three doses, according to the National Cancer Institute. 
 

Why aren’t more young people taking the vaccine? 

Low public awareness of the dangers of HPV may be behind young people’s poor vaccination rates, according to Teresa Lee, MD, of the Fox Chase Cancer Center in Philadelphia. “For example, while the link with head and neck cancers has been well-studied, the FDA labeling was not changed to reflect this as an indication until 2020,” she said.

Other reasons can include one’s socioeconomic background, poor health literacy, cultural or religious stigmas around vaccines, and lack of quality, low-cost health care, says Emmanuel Aguh, MD, a board-certified family medicine physician. “Some individuals and families are still resistant to vaccines and the noted lack of uptake.”

Doctors and other health care professionals should also be sure to tell patients of all ages about the risks of HPV infection and how well the vaccine works, Dr. Lee said. “Not everyone who is now eligible may have been offered the vaccine as a child, and the first time young adults may receive counseling on this subject may not be until they are entering a very busy period of their lives with many responsibilities – when it may be hard to fit in things like health maintenance.”
 

How safe is the HPV vaccine?

The Food and Drug Administration and Centers for Disease Control and Prevention have studied the HPV vaccine for years to find out how safe it is and how well it works, Dr. Aguh said. No major side effects have been reported, and the most common side effect is soreness where you get the shot (which is normal after most vaccines). Some dizziness and fainting in adolescents can also occur, so young people are usually asked to sit or lie down during the shot and for 15 minutes afterward, he said. 

“Serious adverse events have not been reported at higher rates than expected following HPV vaccination, meaning there is no clear evidence they are related to the vaccine,” Dr. Lee said. “The vaccine is highly effective in decreasing rates of detectable infection with the high-risk HPV strains responsible for HPV-associated cancers.”

The HPV vaccine is largely recommended for people aged 9-26, and sometimes up to age 45, depending on the individual, Dr. Aguh said. If you are over 26, talk to your doctor about whether you should consider getting the vaccine.

“It is usually given in two doses for complete protection if taken before the 15th birthday,” Dr. Aguh said. “If taken afterward, or in those with a weak immune system, they might require three doses to be fully protected.”

The vaccine produces antibodies that can stop HPV from infecting cells and lowers your chances of catching an HPV-related cancer, such as throat cancer or cancer of the cervix, he said.

While the vaccine is not guaranteed to protect you from the more than 100 strains of HPV, it can protect you from HPV 16 and HPV 18 – two high-risk strains that cause around 70% of cervical cancers. 
 

What is fueling the rise of HPV cases? 

A misconception that oral sex is somehow a “safe and risk-free” alternative to anal or vaginal sex could be one reason, Dr. Aguh said.

“It is important to know that, with oral sex, you are exposed to many of the risks associated with vaginal intercourse, especially if you do not take any measures to protect yourself and/or your partner,” Dr. Aguh said. “[With oral sex] it is possible to end up contracting an infection like chlamydia, gonorrhea, and even HPV, leading to an increased risk of HPV-associated oropharyngeal cancers.”

A lack of public awareness of what can cause throat cancer could also explain this phenomenon. The number of people you have oral sex with, along with the age you begin sexual activity, can greatly determine your risk of the disease, according to Dr. Lee. She echoes a report by Hisham Mehanna, PhD, in The Conversation.

“For oropharyngeal cancer, the main risk factor is the number of lifetime sexual partners, especially oral sex,” wrote Dr. Mehanna, a professor at the Institute of Cancer and Genomic Sciences at the University of Birmingham (England). “Those with six or more lifetime oral-sex partners are 8.5 times more likely to develop oropharyngeal cancer than those who do not practice oral sex.”
 

What are symptoms of oropharyngeal cancer?

Labored breathing or swallowing, a cough that won’t go away, and crackling or hoarseness of your voice could all be signs of throat cancer. Other symptoms include earaches, swelling of the head or neck, and enlarged lymph nodes, among others, Dr. Aguh said.

“The signs and symptoms of HPV-related throat cancers can be difficult to identify and recognize, as they can be vague and are also associated with other medical conditions. Sometimes, there are no signs at all, or they are not easily noticeable due to the location,” he said. 

You should go see your doctor if you have any of these ailments for an extended period.
 

How to reduce your risk

In addition to having six or more oral-sex partners, smoking and drinking heavily could also raise your risk of throat cancer, said Dr. Lee. Proper dental health – like seeing your dentist regularly and practicing proper oral hygiene – can also shave your risk.

“[Good dental health] can help not just with head and neck cancer risk, but with many other inflammation-related diseases,” Dr. Lee said. 

Using dental dams and condoms can also be a good method of protection, Dr. Aguh said. A dental dam is a stretchy sheet of latex, or polyurethane plastic, in the shape of a square that is made for blocking body fluid to lower your risk of contracting an STD via oral sex. 

Keep in mind: Even with these protections, make sure you and your partner discuss each other’s sexual history, any prior or current STDs and their preferred protection from STDs, said Dr. Aguh.

If you or your partner is being treated for an STD, consider opting out of oral sex and consulting a doctor.

The HPV vaccine is another common method of protection. The shot is “approved for prevention of nine of the most high-risk strains of HPV,” or those that are most commonly linked to cancer, according to Dr. Lee. The vaccine “reduces the frequency of infection” with these viruses, which can ultimately lower the risk of cancers linked to HPV, including cervical, anal, and vulvar and vaginal cancers, she said.

“The best time to receive treatment for prevention of disease is prior to onset of sexual intercourse,” said Dr. Lee.  

To get your HPV vaccine, head to your family doctor, school- or community-based health center, or state health department, suggests the CDC.

A version of this article originally appeared on WebMD.com.

The human papillomavirus (HPV) vaccine may now be as critical as ever, though young people are taking the shot in fewer and fewer numbers. An epidemic of sexually transmitted HPV is now swirling around the United States and the United Kingdom, with some serious cases leading to oropharyngeal cancer, which can affect the back of the throat, tonsils, and tongue.

HPV is the leading cause (70%) of this oropharyngeal cancer, according to the CDC. It is the most common sexually transmitted disease in the nation, and around 3.6% of women and 10% of men report oral HPV specifically. But over the past decade, oropharyngeal cases have been steadily falling a little under 4% and 2%, respectively, according to the National Cancer Institute.

HPV is often undetectable and can clear up within a few months. But unfortunately for some, serious disease, such as throat cancer, can develop. 

Studies show the HPV vaccine to be extremely effective in lowering sexually transmitted HPV cases. Yet, only 54.5% of young people aged 13-15 have taken the recommended two to three doses, according to the National Cancer Institute. 
 

Why aren’t more young people taking the vaccine? 

Low public awareness of the dangers of HPV may be behind young people’s poor vaccination rates, according to Teresa Lee, MD, of the Fox Chase Cancer Center in Philadelphia. “For example, while the link with head and neck cancers has been well-studied, the FDA labeling was not changed to reflect this as an indication until 2020,” she said.

Other reasons can include one’s socioeconomic background, poor health literacy, cultural or religious stigmas around vaccines, and lack of quality, low-cost health care, says Emmanuel Aguh, MD, a board-certified family medicine physician. “Some individuals and families are still resistant to vaccines and the noted lack of uptake.”

Doctors and other health care professionals should also be sure to tell patients of all ages about the risks of HPV infection and how well the vaccine works, Dr. Lee said. “Not everyone who is now eligible may have been offered the vaccine as a child, and the first time young adults may receive counseling on this subject may not be until they are entering a very busy period of their lives with many responsibilities – when it may be hard to fit in things like health maintenance.”
 

How safe is the HPV vaccine?

The Food and Drug Administration and Centers for Disease Control and Prevention have studied the HPV vaccine for years to find out how safe it is and how well it works, Dr. Aguh said. No major side effects have been reported, and the most common side effect is soreness where you get the shot (which is normal after most vaccines). Some dizziness and fainting in adolescents can also occur, so young people are usually asked to sit or lie down during the shot and for 15 minutes afterward, he said. 

“Serious adverse events have not been reported at higher rates than expected following HPV vaccination, meaning there is no clear evidence they are related to the vaccine,” Dr. Lee said. “The vaccine is highly effective in decreasing rates of detectable infection with the high-risk HPV strains responsible for HPV-associated cancers.”

The HPV vaccine is largely recommended for people aged 9-26, and sometimes up to age 45, depending on the individual, Dr. Aguh said. If you are over 26, talk to your doctor about whether you should consider getting the vaccine.

“It is usually given in two doses for complete protection if taken before the 15th birthday,” Dr. Aguh said. “If taken afterward, or in those with a weak immune system, they might require three doses to be fully protected.”

The vaccine produces antibodies that can stop HPV from infecting cells and lowers your chances of catching an HPV-related cancer, such as throat cancer or cancer of the cervix, he said.

While the vaccine is not guaranteed to protect you from the more than 100 strains of HPV, it can protect you from HPV 16 and HPV 18 – two high-risk strains that cause around 70% of cervical cancers. 
 

What is fueling the rise of HPV cases? 

A misconception that oral sex is somehow a “safe and risk-free” alternative to anal or vaginal sex could be one reason, Dr. Aguh said.

“It is important to know that, with oral sex, you are exposed to many of the risks associated with vaginal intercourse, especially if you do not take any measures to protect yourself and/or your partner,” Dr. Aguh said. “[With oral sex] it is possible to end up contracting an infection like chlamydia, gonorrhea, and even HPV, leading to an increased risk of HPV-associated oropharyngeal cancers.”

A lack of public awareness of what can cause throat cancer could also explain this phenomenon. The number of people you have oral sex with, along with the age you begin sexual activity, can greatly determine your risk of the disease, according to Dr. Lee. She echoes a report by Hisham Mehanna, PhD, in The Conversation.

“For oropharyngeal cancer, the main risk factor is the number of lifetime sexual partners, especially oral sex,” wrote Dr. Mehanna, a professor at the Institute of Cancer and Genomic Sciences at the University of Birmingham (England). “Those with six or more lifetime oral-sex partners are 8.5 times more likely to develop oropharyngeal cancer than those who do not practice oral sex.”
 

What are symptoms of oropharyngeal cancer?

Labored breathing or swallowing, a cough that won’t go away, and crackling or hoarseness of your voice could all be signs of throat cancer. Other symptoms include earaches, swelling of the head or neck, and enlarged lymph nodes, among others, Dr. Aguh said.

“The signs and symptoms of HPV-related throat cancers can be difficult to identify and recognize, as they can be vague and are also associated with other medical conditions. Sometimes, there are no signs at all, or they are not easily noticeable due to the location,” he said. 

You should go see your doctor if you have any of these ailments for an extended period.
 

How to reduce your risk

In addition to having six or more oral-sex partners, smoking and drinking heavily could also raise your risk of throat cancer, said Dr. Lee. Proper dental health – like seeing your dentist regularly and practicing proper oral hygiene – can also shave your risk.

“[Good dental health] can help not just with head and neck cancer risk, but with many other inflammation-related diseases,” Dr. Lee said. 

Using dental dams and condoms can also be a good method of protection, Dr. Aguh said. A dental dam is a stretchy sheet of latex, or polyurethane plastic, in the shape of a square that is made for blocking body fluid to lower your risk of contracting an STD via oral sex. 

Keep in mind: Even with these protections, make sure you and your partner discuss each other’s sexual history, any prior or current STDs and their preferred protection from STDs, said Dr. Aguh.

If you or your partner is being treated for an STD, consider opting out of oral sex and consulting a doctor.

The HPV vaccine is another common method of protection. The shot is “approved for prevention of nine of the most high-risk strains of HPV,” or those that are most commonly linked to cancer, according to Dr. Lee. The vaccine “reduces the frequency of infection” with these viruses, which can ultimately lower the risk of cancers linked to HPV, including cervical, anal, and vulvar and vaginal cancers, she said.

“The best time to receive treatment for prevention of disease is prior to onset of sexual intercourse,” said Dr. Lee.  

To get your HPV vaccine, head to your family doctor, school- or community-based health center, or state health department, suggests the CDC.

A version of this article originally appeared on WebMD.com.

Vaginal microbiota transfer may facilitate normal neurodevelopment for infants born via cesarean delivery, based on data from a new pilot study of 68 infants.

Previous studies have shown that gut microbiota in infancy could affect neurodevelopment, and infants delivered by cesarean are not exposed to potentially helpful microbes acquired by infants during vaginal delivery, wrote Lepeng Zhou, MD, of Southern Medical University, Guangdong, China, and colleagues.

“Infants delivered by C-section start life with very different bacteria than those born vaginally,” corresponding author Jose Clemente, PhD, of Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Because this is the first time the newborn is exposed to microbes, we and others have hypothesized for some time that this ‘first encounter’ might be significant to shape the development of the baby,” he said.

“A few years ago, we demonstrated that it is possible to change the microbiome of C-section–delivered infants using an intervention that makes their microbiome more similar to that of a vaginally-delivered infant,” Dr. Clemente told this news organization. “In this study just published, we show that this procedure not only changes the microbiome of C-section infants, but it also modifies a health outcome (in this case, neurodevelopment). This is highly significant because it opens the way to reduce the risk that C-section infants have for certain conditions through a very simple microbial intervention,” he said.
 

‘Significantly higher’ ASQ-3 scores

In the current study, published in Cell Host & Microbe, the researchers examined the impact of vaginal microbiota transfer (VMT) on the neurodevelopment of cesarean-delivered infants. They randomized 35 women scheduled for cesarean delivery with a single infant to VMT and 41 to a control intervention of saline gauze for their infants immediately after delivery.

The primary outcome of infant neurodevelopment was assessed using the Ages and Stages Questionnaire (ASQ-3) score at 6 months. The researchers also collected fecal samples and assessed safety outcomes for the infants at 3, 7, 30, and 42 days after birth. The final analysis comprised 32 infants in the VMT group and 36 in the control group. The mean age of the mothers was 32 years; the mean gestational age of the infants was 39 weeks, but the difference was significant and slightly less in the VMT group compared with the controls (38.38 weeks vs. 39.13 weeks, P = .007). A group of 33 vaginally-delivered infants (VD) underwent ASQ-3 testing to serve as a reference group.

At 6 months, ASQ-3 scores were significantly higher (10.09%, P = .014) with VMT compared with controls, and the difference remained significant after adjustment for multiple factors including gestational age.

ASQ-3 total scores at 6 months were not significantly different between the VMT group and the VD reference group (mean difference of 8.84 VMT to VD, P = .346); scores between these groups also were similar at 3 months (mean difference of –1.48 VMT to VD, P = .900) and no significant differences appeared in ASQ-3 subdomains between these groups at either time period.

An examination of gut metabolites in stool showed significant differences in fecal metabolites and metabolic function, signs of gut microbiota maturation, the researchers noted.

“Interestingly, all the genera and metabolites that exhibited positive correlations with neurodevelopmental scores were upregulated in the VMT group, whereas the only negative correlation of Klebsiella was downregulated, indicating that VMT may impact neurodevelopment through the modulation of specific gut microbial genera and metabolites,” the researchers wrote.

No serious adverse events occurred in either group during the study period. Nine adverse events were reported; 4 in the VMT group and 5 in the control group. The most common AEs were mild skin disorders, including papules, pustules, and erythema.

The findings were limited by several factors including the potential for transfer not only of vaginal microbiota, but also vaginal metabolites, mycobiome, and virome, which blurs the potential mechanism of VMT, the researchers noted. Other limitations were the relatively short study period, small sample size, and cervical HPV screening within the past 5 years, not during pregnancy, they wrote.

However, the results suggest that VMT is safe, and may help improve the fecal microbiome in cesarean-delivered infants, and the long-term effects merit further studies in larger populations, they concluded.
 

Limitations and outlook

Dr. Clemente said in an interview that the researchers were “hopeful that the study would demonstrate a health benefit, as it does with some limitations.” The current study findings confirm some previous results showing that modification of the microbiomes of C-section infants is possible through a transfer of maternal vaginal microbes, he said.

“There is also an important aspect that was confirmed here: The lack of serious adverse events associated with the procedure, and the fact that transferring vaginal microbes did not increase the risk of adverse events compared to the control group or to vaginally-delivered infants. This is fundamental to establish that using rigorous exclusion criteria we can perform this procedure safely for infants and mothers,” he added.

“We are at very early stages yet to talk about clinical implications,” said Dr. Clemente. “This is one of the first studies to demonstrate a benefit to the transfer of microbes from mothers to infants, and as such it opens the way for future trials that confirm these findings. The clinical application is still in the future, but this is an important first step towards that goal.”

Interest in restoring gut microbiota to potentially benefit infants persists, but a recent study published in Frontiers and Cellular and Infection Microbiology contradicted the potential association between maternal vaginal microbiome and an infant’s gut microbiome based on an analysis of infant stool.

“There are many reasons why different studies might reach different conclusions: The experimental procedures, the analytical methods, the cohort under study,” Dr. Clemente said when asked to comment on the Frontiers study. “Further studies are needed to establish whether this procedure is equally effective under all conditions and whether health benefits are generalizable or specific to particular populations.”

Several research gaps remain, Dr. Clemente said. “First, neurodevelopment was measured through a questionnaire that captures various aspects such as communication, motor skills, or problem solving. While this is a standard way to establish that an infant is in the correct neurodevelopmental pathway, it is not a ‘hard’ measure of cellular or biochemical processes being impacted by the intervention. Some of our results suggest that there is a change in the metabolome of this infants, particularly an enrichment in GABA, a neurotransmitter, but the exact mechanisms by which the intervention is resulting in a health benefit still remains to be explored,” he said.

“We have an ongoing study here at Mount Sinai to test whether this microbial intervention can be effective in lowering the risk of developing food allergies in newborns who are at high risk, so that is another important future question: What other conditions could benefit from this approach,” said Dr. Clemente.

A third research goal, he added, is “determining what microbes precisely are responsible for the health benefits; this study uses a full microbial community to colonize infants. We show that this is effective and, importantly, that there were no significant adverse events in the treated infants,” he noted. “However, identifying what specific microbes are beneficial would further lower the risk of any potential side effects, while facilitating the development of drugs based on defined microbial consortia,” he said.
 

Safety and efficacy support further studies

“It is widely accepted that the gut microbiome of neonates varies based on mode of delivery,” Anna K. Knight, PhD, assistant professor of gynecology and obstetrics at Emory University, Atlanta, said in an interview.

“C-sections have been associated with increased risk of asthma and metabolic disease, and have been associated with differences in the development of the immune system,” said Dr. Knight, who was not involved in the study. “There have been small pilot studies examining the use of vaginal microbiome transplants to shift the gut microbiome of neonates born by C-section to be more like the gut microbiome of neonates born via vaginal delivery, but the safety and efficacy of this treatment has not been well established. This study examines both, while also evaluating potential changes in the metabolome and neurodevelopmental trajectories.”

The current study confirmed the impact of the neonatal gut microbe on neurodevelopmental outcomes during a sensitive period, said Dr. Knight. “The fact that these differences persisted at 6 months suggests that even if the microbiome composition between vaginally-delivered and preterm infants converged at 1-2 years old, there may be lasting impacts of mode of delivery,” she said.

“The results of this study suggest that vaginal microbiome transplant may be a safe and effective way to mitigate the negative impacts of C-section delivery on the neonatal gut microbiome, and may be protective for neurodevelopment,” she added.

Regarding the Frontiers in Medicine study, Dr. Knight noted that it examined a very different population, with Zhou and colleagues focusing on Chinese infants, while Dos Santos and colleagues focused on Canadian infants.

“There was also a substantial difference in sample size between the two studies, with Dos Santos and colleagues examining > 500 more infants,” she said. “Additionally, the two studies differed in the sequencing technology used, sample collection methods, and antibiotic exposure, which can all impact microbiome study results.”

Since the current study showed efficacy and safety of VMT in a small clinical trial, larger trials with more diverse participants are needed to further examine the impact of VMT, said Dr. Knight. “The risks of vaginal microbiome transplant in mothers with infections should also be considered, and the mechanisms by which the neonatal gut microbiome impacts neurodevelopment need further investigation,” she said.

The study was funded by the National Key R&D Program of China, the Canadian Institute of Health Research, the National Natural Science Foundation of China, the Clinical Research Startup Program of Southern Medical University, China, and the Top Talent Program of Foshan Women and Children Hospital, China. The researchers and Dr. Knight had no financial conflicts to disclose.

Vaginal microbiota transfer may facilitate normal neurodevelopment for infants born via cesarean delivery, based on data from a new pilot study of 68 infants.

Previous studies have shown that gut microbiota in infancy could affect neurodevelopment, and infants delivered by cesarean are not exposed to potentially helpful microbes acquired by infants during vaginal delivery, wrote Lepeng Zhou, MD, of Southern Medical University, Guangdong, China, and colleagues.

“Infants delivered by C-section start life with very different bacteria than those born vaginally,” corresponding author Jose Clemente, PhD, of Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Because this is the first time the newborn is exposed to microbes, we and others have hypothesized for some time that this ‘first encounter’ might be significant to shape the development of the baby,” he said.

“A few years ago, we demonstrated that it is possible to change the microbiome of C-section–delivered infants using an intervention that makes their microbiome more similar to that of a vaginally-delivered infant,” Dr. Clemente told this news organization. “In this study just published, we show that this procedure not only changes the microbiome of C-section infants, but it also modifies a health outcome (in this case, neurodevelopment). This is highly significant because it opens the way to reduce the risk that C-section infants have for certain conditions through a very simple microbial intervention,” he said.
 

‘Significantly higher’ ASQ-3 scores

In the current study, published in Cell Host & Microbe, the researchers examined the impact of vaginal microbiota transfer (VMT) on the neurodevelopment of cesarean-delivered infants. They randomized 35 women scheduled for cesarean delivery with a single infant to VMT and 41 to a control intervention of saline gauze for their infants immediately after delivery.

The primary outcome of infant neurodevelopment was assessed using the Ages and Stages Questionnaire (ASQ-3) score at 6 months. The researchers also collected fecal samples and assessed safety outcomes for the infants at 3, 7, 30, and 42 days after birth. The final analysis comprised 32 infants in the VMT group and 36 in the control group. The mean age of the mothers was 32 years; the mean gestational age of the infants was 39 weeks, but the difference was significant and slightly less in the VMT group compared with the controls (38.38 weeks vs. 39.13 weeks, P = .007). A group of 33 vaginally-delivered infants (VD) underwent ASQ-3 testing to serve as a reference group.

At 6 months, ASQ-3 scores were significantly higher (10.09%, P = .014) with VMT compared with controls, and the difference remained significant after adjustment for multiple factors including gestational age.

ASQ-3 total scores at 6 months were not significantly different between the VMT group and the VD reference group (mean difference of 8.84 VMT to VD, P = .346); scores between these groups also were similar at 3 months (mean difference of –1.48 VMT to VD, P = .900) and no significant differences appeared in ASQ-3 subdomains between these groups at either time period.

An examination of gut metabolites in stool showed significant differences in fecal metabolites and metabolic function, signs of gut microbiota maturation, the researchers noted.

“Interestingly, all the genera and metabolites that exhibited positive correlations with neurodevelopmental scores were upregulated in the VMT group, whereas the only negative correlation of Klebsiella was downregulated, indicating that VMT may impact neurodevelopment through the modulation of specific gut microbial genera and metabolites,” the researchers wrote.

No serious adverse events occurred in either group during the study period. Nine adverse events were reported; 4 in the VMT group and 5 in the control group. The most common AEs were mild skin disorders, including papules, pustules, and erythema.

The findings were limited by several factors including the potential for transfer not only of vaginal microbiota, but also vaginal metabolites, mycobiome, and virome, which blurs the potential mechanism of VMT, the researchers noted. Other limitations were the relatively short study period, small sample size, and cervical HPV screening within the past 5 years, not during pregnancy, they wrote.

However, the results suggest that VMT is safe, and may help improve the fecal microbiome in cesarean-delivered infants, and the long-term effects merit further studies in larger populations, they concluded.
 

Limitations and outlook

Dr. Clemente said in an interview that the researchers were “hopeful that the study would demonstrate a health benefit, as it does with some limitations.” The current study findings confirm some previous results showing that modification of the microbiomes of C-section infants is possible through a transfer of maternal vaginal microbes, he said.

“There is also an important aspect that was confirmed here: The lack of serious adverse events associated with the procedure, and the fact that transferring vaginal microbes did not increase the risk of adverse events compared to the control group or to vaginally-delivered infants. This is fundamental to establish that using rigorous exclusion criteria we can perform this procedure safely for infants and mothers,” he added.

“We are at very early stages yet to talk about clinical implications,” said Dr. Clemente. “This is one of the first studies to demonstrate a benefit to the transfer of microbes from mothers to infants, and as such it opens the way for future trials that confirm these findings. The clinical application is still in the future, but this is an important first step towards that goal.”

Interest in restoring gut microbiota to potentially benefit infants persists, but a recent study published in Frontiers and Cellular and Infection Microbiology contradicted the potential association between maternal vaginal microbiome and an infant’s gut microbiome based on an analysis of infant stool.

“There are many reasons why different studies might reach different conclusions: The experimental procedures, the analytical methods, the cohort under study,” Dr. Clemente said when asked to comment on the Frontiers study. “Further studies are needed to establish whether this procedure is equally effective under all conditions and whether health benefits are generalizable or specific to particular populations.”

Several research gaps remain, Dr. Clemente said. “First, neurodevelopment was measured through a questionnaire that captures various aspects such as communication, motor skills, or problem solving. While this is a standard way to establish that an infant is in the correct neurodevelopmental pathway, it is not a ‘hard’ measure of cellular or biochemical processes being impacted by the intervention. Some of our results suggest that there is a change in the metabolome of this infants, particularly an enrichment in GABA, a neurotransmitter, but the exact mechanisms by which the intervention is resulting in a health benefit still remains to be explored,” he said.

“We have an ongoing study here at Mount Sinai to test whether this microbial intervention can be effective in lowering the risk of developing food allergies in newborns who are at high risk, so that is another important future question: What other conditions could benefit from this approach,” said Dr. Clemente.

A third research goal, he added, is “determining what microbes precisely are responsible for the health benefits; this study uses a full microbial community to colonize infants. We show that this is effective and, importantly, that there were no significant adverse events in the treated infants,” he noted. “However, identifying what specific microbes are beneficial would further lower the risk of any potential side effects, while facilitating the development of drugs based on defined microbial consortia,” he said.
 

Safety and efficacy support further studies

“It is widely accepted that the gut microbiome of neonates varies based on mode of delivery,” Anna K. Knight, PhD, assistant professor of gynecology and obstetrics at Emory University, Atlanta, said in an interview.

“C-sections have been associated with increased risk of asthma and metabolic disease, and have been associated with differences in the development of the immune system,” said Dr. Knight, who was not involved in the study. “There have been small pilot studies examining the use of vaginal microbiome transplants to shift the gut microbiome of neonates born by C-section to be more like the gut microbiome of neonates born via vaginal delivery, but the safety and efficacy of this treatment has not been well established. This study examines both, while also evaluating potential changes in the metabolome and neurodevelopmental trajectories.”

The current study confirmed the impact of the neonatal gut microbe on neurodevelopmental outcomes during a sensitive period, said Dr. Knight. “The fact that these differences persisted at 6 months suggests that even if the microbiome composition between vaginally-delivered and preterm infants converged at 1-2 years old, there may be lasting impacts of mode of delivery,” she said.

“The results of this study suggest that vaginal microbiome transplant may be a safe and effective way to mitigate the negative impacts of C-section delivery on the neonatal gut microbiome, and may be protective for neurodevelopment,” she added.

Regarding the Frontiers in Medicine study, Dr. Knight noted that it examined a very different population, with Zhou and colleagues focusing on Chinese infants, while Dos Santos and colleagues focused on Canadian infants.

“There was also a substantial difference in sample size between the two studies, with Dos Santos and colleagues examining > 500 more infants,” she said. “Additionally, the two studies differed in the sequencing technology used, sample collection methods, and antibiotic exposure, which can all impact microbiome study results.”

Since the current study showed efficacy and safety of VMT in a small clinical trial, larger trials with more diverse participants are needed to further examine the impact of VMT, said Dr. Knight. “The risks of vaginal microbiome transplant in mothers with infections should also be considered, and the mechanisms by which the neonatal gut microbiome impacts neurodevelopment need further investigation,” she said.

The study was funded by the National Key R&D Program of China, the Canadian Institute of Health Research, the National Natural Science Foundation of China, the Clinical Research Startup Program of Southern Medical University, China, and the Top Talent Program of Foshan Women and Children Hospital, China. The researchers and Dr. Knight had no financial conflicts to disclose.

Vaginal microbiota transfer may facilitate normal neurodevelopment for infants born via cesarean delivery, based on data from a new pilot study of 68 infants.

Previous studies have shown that gut microbiota in infancy could affect neurodevelopment, and infants delivered by cesarean are not exposed to potentially helpful microbes acquired by infants during vaginal delivery, wrote Lepeng Zhou, MD, of Southern Medical University, Guangdong, China, and colleagues.

“Infants delivered by C-section start life with very different bacteria than those born vaginally,” corresponding author Jose Clemente, PhD, of Icahn School of Medicine at Mount Sinai, New York, said in an interview. “Because this is the first time the newborn is exposed to microbes, we and others have hypothesized for some time that this ‘first encounter’ might be significant to shape the development of the baby,” he said.

“A few years ago, we demonstrated that it is possible to change the microbiome of C-section–delivered infants using an intervention that makes their microbiome more similar to that of a vaginally-delivered infant,” Dr. Clemente told this news organization. “In this study just published, we show that this procedure not only changes the microbiome of C-section infants, but it also modifies a health outcome (in this case, neurodevelopment). This is highly significant because it opens the way to reduce the risk that C-section infants have for certain conditions through a very simple microbial intervention,” he said.
 

‘Significantly higher’ ASQ-3 scores

In the current study, published in Cell Host & Microbe, the researchers examined the impact of vaginal microbiota transfer (VMT) on the neurodevelopment of cesarean-delivered infants. They randomized 35 women scheduled for cesarean delivery with a single infant to VMT and 41 to a control intervention of saline gauze for their infants immediately after delivery.

The primary outcome of infant neurodevelopment was assessed using the Ages and Stages Questionnaire (ASQ-3) score at 6 months. The researchers also collected fecal samples and assessed safety outcomes for the infants at 3, 7, 30, and 42 days after birth. The final analysis comprised 32 infants in the VMT group and 36 in the control group. The mean age of the mothers was 32 years; the mean gestational age of the infants was 39 weeks, but the difference was significant and slightly less in the VMT group compared with the controls (38.38 weeks vs. 39.13 weeks, P = .007). A group of 33 vaginally-delivered infants (VD) underwent ASQ-3 testing to serve as a reference group.

At 6 months, ASQ-3 scores were significantly higher (10.09%, P = .014) with VMT compared with controls, and the difference remained significant after adjustment for multiple factors including gestational age.

ASQ-3 total scores at 6 months were not significantly different between the VMT group and the VD reference group (mean difference of 8.84 VMT to VD, P = .346); scores between these groups also were similar at 3 months (mean difference of –1.48 VMT to VD, P = .900) and no significant differences appeared in ASQ-3 subdomains between these groups at either time period.

An examination of gut metabolites in stool showed significant differences in fecal metabolites and metabolic function, signs of gut microbiota maturation, the researchers noted.

“Interestingly, all the genera and metabolites that exhibited positive correlations with neurodevelopmental scores were upregulated in the VMT group, whereas the only negative correlation of Klebsiella was downregulated, indicating that VMT may impact neurodevelopment through the modulation of specific gut microbial genera and metabolites,” the researchers wrote.

No serious adverse events occurred in either group during the study period. Nine adverse events were reported; 4 in the VMT group and 5 in the control group. The most common AEs were mild skin disorders, including papules, pustules, and erythema.

The findings were limited by several factors including the potential for transfer not only of vaginal microbiota, but also vaginal metabolites, mycobiome, and virome, which blurs the potential mechanism of VMT, the researchers noted. Other limitations were the relatively short study period, small sample size, and cervical HPV screening within the past 5 years, not during pregnancy, they wrote.

However, the results suggest that VMT is safe, and may help improve the fecal microbiome in cesarean-delivered infants, and the long-term effects merit further studies in larger populations, they concluded.
 

Limitations and outlook

Dr. Clemente said in an interview that the researchers were “hopeful that the study would demonstrate a health benefit, as it does with some limitations.” The current study findings confirm some previous results showing that modification of the microbiomes of C-section infants is possible through a transfer of maternal vaginal microbes, he said.

“There is also an important aspect that was confirmed here: The lack of serious adverse events associated with the procedure, and the fact that transferring vaginal microbes did not increase the risk of adverse events compared to the control group or to vaginally-delivered infants. This is fundamental to establish that using rigorous exclusion criteria we can perform this procedure safely for infants and mothers,” he added.

“We are at very early stages yet to talk about clinical implications,” said Dr. Clemente. “This is one of the first studies to demonstrate a benefit to the transfer of microbes from mothers to infants, and as such it opens the way for future trials that confirm these findings. The clinical application is still in the future, but this is an important first step towards that goal.”

Interest in restoring gut microbiota to potentially benefit infants persists, but a recent study published in Frontiers and Cellular and Infection Microbiology contradicted the potential association between maternal vaginal microbiome and an infant’s gut microbiome based on an analysis of infant stool.

“There are many reasons why different studies might reach different conclusions: The experimental procedures, the analytical methods, the cohort under study,” Dr. Clemente said when asked to comment on the Frontiers study. “Further studies are needed to establish whether this procedure is equally effective under all conditions and whether health benefits are generalizable or specific to particular populations.”

Several research gaps remain, Dr. Clemente said. “First, neurodevelopment was measured through a questionnaire that captures various aspects such as communication, motor skills, or problem solving. While this is a standard way to establish that an infant is in the correct neurodevelopmental pathway, it is not a ‘hard’ measure of cellular or biochemical processes being impacted by the intervention. Some of our results suggest that there is a change in the metabolome of this infants, particularly an enrichment in GABA, a neurotransmitter, but the exact mechanisms by which the intervention is resulting in a health benefit still remains to be explored,” he said.

“We have an ongoing study here at Mount Sinai to test whether this microbial intervention can be effective in lowering the risk of developing food allergies in newborns who are at high risk, so that is another important future question: What other conditions could benefit from this approach,” said Dr. Clemente.

A third research goal, he added, is “determining what microbes precisely are responsible for the health benefits; this study uses a full microbial community to colonize infants. We show that this is effective and, importantly, that there were no significant adverse events in the treated infants,” he noted. “However, identifying what specific microbes are beneficial would further lower the risk of any potential side effects, while facilitating the development of drugs based on defined microbial consortia,” he said.
 

Safety and efficacy support further studies

“It is widely accepted that the gut microbiome of neonates varies based on mode of delivery,” Anna K. Knight, PhD, assistant professor of gynecology and obstetrics at Emory University, Atlanta, said in an interview.

“C-sections have been associated with increased risk of asthma and metabolic disease, and have been associated with differences in the development of the immune system,” said Dr. Knight, who was not involved in the study. “There have been small pilot studies examining the use of vaginal microbiome transplants to shift the gut microbiome of neonates born by C-section to be more like the gut microbiome of neonates born via vaginal delivery, but the safety and efficacy of this treatment has not been well established. This study examines both, while also evaluating potential changes in the metabolome and neurodevelopmental trajectories.”

The current study confirmed the impact of the neonatal gut microbe on neurodevelopmental outcomes during a sensitive period, said Dr. Knight. “The fact that these differences persisted at 6 months suggests that even if the microbiome composition between vaginally-delivered and preterm infants converged at 1-2 years old, there may be lasting impacts of mode of delivery,” she said.

“The results of this study suggest that vaginal microbiome transplant may be a safe and effective way to mitigate the negative impacts of C-section delivery on the neonatal gut microbiome, and may be protective for neurodevelopment,” she added.

Regarding the Frontiers in Medicine study, Dr. Knight noted that it examined a very different population, with Zhou and colleagues focusing on Chinese infants, while Dos Santos and colleagues focused on Canadian infants.

“There was also a substantial difference in sample size between the two studies, with Dos Santos and colleagues examining > 500 more infants,” she said. “Additionally, the two studies differed in the sequencing technology used, sample collection methods, and antibiotic exposure, which can all impact microbiome study results.”

Since the current study showed efficacy and safety of VMT in a small clinical trial, larger trials with more diverse participants are needed to further examine the impact of VMT, said Dr. Knight. “The risks of vaginal microbiome transplant in mothers with infections should also be considered, and the mechanisms by which the neonatal gut microbiome impacts neurodevelopment need further investigation,” she said.

The study was funded by the National Key R&D Program of China, the Canadian Institute of Health Research, the National Natural Science Foundation of China, the Clinical Research Startup Program of Southern Medical University, China, and the Top Talent Program of Foshan Women and Children Hospital, China. The researchers and Dr. Knight had no financial conflicts to disclose.

SAN DIEGO – Children with type 2 diabetes face a strikingly high complication rate as they age into young adulthood, with an 80% incidence of at least one vascular complication during up to 15 years of follow-up, show findings from the TODAY prospective, longitudinal study of 699 U.S. children newly diagnosed with type 2 diabetes.

Arterial stiffness and worsened cardiac function often appear in these children within 2-5 years of diagnosis and seem driven in part by the development of hypertension and worsening hemoglobin A1c levels, said Rachelle G. Gandica, MD, at the annual scientific sessions of the American Diabetes Association.

Indeed, an A1c greater than 6.2% at study entry generally predicts these children will fail treatment and is a red flag, said Dr. Gandica. “I teach fellows this all the time, that if a child’s A1c is above 6.2% they will fail, and you have to watch for that,” she noted.

Mitchel L. Zoler/Medscape

The results from the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study showed, for example, an overall cardiovascular event rate of 3.7/1,000 patient-years in a population that had just reached an average age of 26 years old, with type 2 diabetes diagnosed for an average of more than 13 years.

During follow-up, there were six cases of congestive heart failure, four myocardial infarctions, four strokes, and three cases of coronary artery disease in the cohort. Hypertension ballooned from a prevalence of 19% at study entry to 68% by the end of follow-up.

Dr. Gandica called these and other findings “sobering details” that document the toll type 2 diabetes takes on children, who averaged 14 years old at the time they entered the study – when their diabetes had been diagnosed for an average of about 8 months – and then underwent an average 12.6 years of follow-up.

Investigators also found:

• After more than 12 years of type 2 diabetes, 49% of the cohort had developed diabetic retinopathy, with 3.5% having macular edema.
• Kidney damage (diabetic nephropathy) affected 8% of the cohort at entry, and then increased to a prevalence of 55% after up to 14 years of follow-up.
• Among the 452 girls who entered the study, 141 (31%) later became pregnant, with a total of 260 pregnancies. A quarter of the pregnancies resulted in preterm deliveries (43% went to term), 25% resulted in miscarriage or fetal demise, with the remaining 8% having elective terminations or unknown outcomes.
• Complications in neonates were common, including hypoglycemia (29%), respiratory disorder (19%), and cardiac issues (10%).

Dire prognosis a reason to aggressively treat these patients

It has become apparent from this and other studies in youth with type 2 diabetes that the difference in outcomes between youth and adults is stark and could indicate that type 2 diabetes in childhood or adolescence likely has a different underlying pathology and natural history, with a more aggressive disease course.

The dire prognosis is therefore a reason to aggressively treat these patients with antidiabetic medications from drug classes with proven cardiovascular disease protection, specifically sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagonlike peptide-1 (GLP-1) agonists, said Dr. Gandica, a pediatric endocrinologist at Columbia University Medical Center in New York.

“It’s fair to say we now more aggressively use [these agents] in children,” she said in an interview, and noted the very recent approval, just last week, by the U.S. Food and Drug Administration of the SGLT2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim/Lilly) for children as young as 10 years.

“I look forward to prescribing empagliflozin to children with type 2 diabetes to lower their blood pressure and get additional cardiovascular disease benefits,” Dr. Gandica said.

Other newer type 2 diabetes medications approved for U.S. children in the past few years include the once-weekly injectable GLP-1 agonist exenatide extended release (Bydureon/Bydureon BCise, AstraZeneca) for children with type 2 diabetes aged 10 and older, in 2021, and the daily injectable GLP-1 agonist liraglutide (Victoza, Novo Nordisk) in 2019.
 

A1c spike heralds treatment failure: ‘Watch for that’

TODAY enrolled 699 children with type 2 diabetes for an average of 8 months since diagnosis at 16 U.S. sites starting in 2004. The protocol began with a run-in phase of up to 6 months, when participating children came off any preexisting antidiabetes medications and then began a metformin-only regimen to bring A1c below 8.0%. If achieved, patients were eligible to continue to randomization.

Participants were randomized to one of three treatment groups: metformin alone, metformin plus lifestyle interventions, or metformin plus rosiglitazone (Avandia, GSK). The primary endpoint was the incidence of treatment failure, defined as A1c that rose back above 8.0% for at least 6 months or persistent metabolic decompensation during initial follow-up, for an average of just under 4 years.

The results showed that only metformin plus rosiglitazone significantly surpassed metformin alone for preventing treatment failure, reported in 2012 in the New England Journal of Medicine

More recent reports on findings from longer-term follow-up have appeared in several journals, including the cardiovascular disease results, reported in 2021 also in the New England Journal of Medicine.

Another key finding from TODAY is the importance of A1c as a risk marker for impending treatment failure. Study findingsshow that an A1c of 6.2% or higher when children entered the study best predicted loss of glycemic control during follow-up. Also, a rise in A1c of at least 0.5 percentage points was significantly associated with loss of glycemic control within the following 3-6 months.

That’s an important message for clinicians, Dr. Gandica concluded.

TODAY and TODAY2 received no commercial funding. Dr. Gandica has reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

SAN DIEGO – Children with type 2 diabetes face a strikingly high complication rate as they age into young adulthood, with an 80% incidence of at least one vascular complication during up to 15 years of follow-up, show findings from the TODAY prospective, longitudinal study of 699 U.S. children newly diagnosed with type 2 diabetes.

Arterial stiffness and worsened cardiac function often appear in these children within 2-5 years of diagnosis and seem driven in part by the development of hypertension and worsening hemoglobin A1c levels, said Rachelle G. Gandica, MD, at the annual scientific sessions of the American Diabetes Association.

Indeed, an A1c greater than 6.2% at study entry generally predicts these children will fail treatment and is a red flag, said Dr. Gandica. “I teach fellows this all the time, that if a child’s A1c is above 6.2% they will fail, and you have to watch for that,” she noted.

Mitchel L. Zoler/Medscape

The results from the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study showed, for example, an overall cardiovascular event rate of 3.7/1,000 patient-years in a population that had just reached an average age of 26 years old, with type 2 diabetes diagnosed for an average of more than 13 years.

During follow-up, there were six cases of congestive heart failure, four myocardial infarctions, four strokes, and three cases of coronary artery disease in the cohort. Hypertension ballooned from a prevalence of 19% at study entry to 68% by the end of follow-up.

Dr. Gandica called these and other findings “sobering details” that document the toll type 2 diabetes takes on children, who averaged 14 years old at the time they entered the study – when their diabetes had been diagnosed for an average of about 8 months – and then underwent an average 12.6 years of follow-up.

Investigators also found:

• After more than 12 years of type 2 diabetes, 49% of the cohort had developed diabetic retinopathy, with 3.5% having macular edema.
• Kidney damage (diabetic nephropathy) affected 8% of the cohort at entry, and then increased to a prevalence of 55% after up to 14 years of follow-up.
• Among the 452 girls who entered the study, 141 (31%) later became pregnant, with a total of 260 pregnancies. A quarter of the pregnancies resulted in preterm deliveries (43% went to term), 25% resulted in miscarriage or fetal demise, with the remaining 8% having elective terminations or unknown outcomes.
• Complications in neonates were common, including hypoglycemia (29%), respiratory disorder (19%), and cardiac issues (10%).

Dire prognosis a reason to aggressively treat these patients

It has become apparent from this and other studies in youth with type 2 diabetes that the difference in outcomes between youth and adults is stark and could indicate that type 2 diabetes in childhood or adolescence likely has a different underlying pathology and natural history, with a more aggressive disease course.

The dire prognosis is therefore a reason to aggressively treat these patients with antidiabetic medications from drug classes with proven cardiovascular disease protection, specifically sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagonlike peptide-1 (GLP-1) agonists, said Dr. Gandica, a pediatric endocrinologist at Columbia University Medical Center in New York.

“It’s fair to say we now more aggressively use [these agents] in children,” she said in an interview, and noted the very recent approval, just last week, by the U.S. Food and Drug Administration of the SGLT2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim/Lilly) for children as young as 10 years.

“I look forward to prescribing empagliflozin to children with type 2 diabetes to lower their blood pressure and get additional cardiovascular disease benefits,” Dr. Gandica said.

Other newer type 2 diabetes medications approved for U.S. children in the past few years include the once-weekly injectable GLP-1 agonist exenatide extended release (Bydureon/Bydureon BCise, AstraZeneca) for children with type 2 diabetes aged 10 and older, in 2021, and the daily injectable GLP-1 agonist liraglutide (Victoza, Novo Nordisk) in 2019.
 

A1c spike heralds treatment failure: ‘Watch for that’

TODAY enrolled 699 children with type 2 diabetes for an average of 8 months since diagnosis at 16 U.S. sites starting in 2004. The protocol began with a run-in phase of up to 6 months, when participating children came off any preexisting antidiabetes medications and then began a metformin-only regimen to bring A1c below 8.0%. If achieved, patients were eligible to continue to randomization.

Participants were randomized to one of three treatment groups: metformin alone, metformin plus lifestyle interventions, or metformin plus rosiglitazone (Avandia, GSK). The primary endpoint was the incidence of treatment failure, defined as A1c that rose back above 8.0% for at least 6 months or persistent metabolic decompensation during initial follow-up, for an average of just under 4 years.

The results showed that only metformin plus rosiglitazone significantly surpassed metformin alone for preventing treatment failure, reported in 2012 in the New England Journal of Medicine

More recent reports on findings from longer-term follow-up have appeared in several journals, including the cardiovascular disease results, reported in 2021 also in the New England Journal of Medicine.

Another key finding from TODAY is the importance of A1c as a risk marker for impending treatment failure. Study findingsshow that an A1c of 6.2% or higher when children entered the study best predicted loss of glycemic control during follow-up. Also, a rise in A1c of at least 0.5 percentage points was significantly associated with loss of glycemic control within the following 3-6 months.

That’s an important message for clinicians, Dr. Gandica concluded.

TODAY and TODAY2 received no commercial funding. Dr. Gandica has reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

SAN DIEGO – Children with type 2 diabetes face a strikingly high complication rate as they age into young adulthood, with an 80% incidence of at least one vascular complication during up to 15 years of follow-up, show findings from the TODAY prospective, longitudinal study of 699 U.S. children newly diagnosed with type 2 diabetes.

Arterial stiffness and worsened cardiac function often appear in these children within 2-5 years of diagnosis and seem driven in part by the development of hypertension and worsening hemoglobin A1c levels, said Rachelle G. Gandica, MD, at the annual scientific sessions of the American Diabetes Association.

Indeed, an A1c greater than 6.2% at study entry generally predicts these children will fail treatment and is a red flag, said Dr. Gandica. “I teach fellows this all the time, that if a child’s A1c is above 6.2% they will fail, and you have to watch for that,” she noted.

Mitchel L. Zoler/Medscape

The results from the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study showed, for example, an overall cardiovascular event rate of 3.7/1,000 patient-years in a population that had just reached an average age of 26 years old, with type 2 diabetes diagnosed for an average of more than 13 years.

During follow-up, there were six cases of congestive heart failure, four myocardial infarctions, four strokes, and three cases of coronary artery disease in the cohort. Hypertension ballooned from a prevalence of 19% at study entry to 68% by the end of follow-up.

Dr. Gandica called these and other findings “sobering details” that document the toll type 2 diabetes takes on children, who averaged 14 years old at the time they entered the study – when their diabetes had been diagnosed for an average of about 8 months – and then underwent an average 12.6 years of follow-up.

Investigators also found:

• After more than 12 years of type 2 diabetes, 49% of the cohort had developed diabetic retinopathy, with 3.5% having macular edema.
• Kidney damage (diabetic nephropathy) affected 8% of the cohort at entry, and then increased to a prevalence of 55% after up to 14 years of follow-up.
• Among the 452 girls who entered the study, 141 (31%) later became pregnant, with a total of 260 pregnancies. A quarter of the pregnancies resulted in preterm deliveries (43% went to term), 25% resulted in miscarriage or fetal demise, with the remaining 8% having elective terminations or unknown outcomes.
• Complications in neonates were common, including hypoglycemia (29%), respiratory disorder (19%), and cardiac issues (10%).

Dire prognosis a reason to aggressively treat these patients

It has become apparent from this and other studies in youth with type 2 diabetes that the difference in outcomes between youth and adults is stark and could indicate that type 2 diabetes in childhood or adolescence likely has a different underlying pathology and natural history, with a more aggressive disease course.

The dire prognosis is therefore a reason to aggressively treat these patients with antidiabetic medications from drug classes with proven cardiovascular disease protection, specifically sodium-glucose cotransporter 2 (SGLT2) inhibitors and glucagonlike peptide-1 (GLP-1) agonists, said Dr. Gandica, a pediatric endocrinologist at Columbia University Medical Center in New York.

“It’s fair to say we now more aggressively use [these agents] in children,” she said in an interview, and noted the very recent approval, just last week, by the U.S. Food and Drug Administration of the SGLT2 inhibitor empagliflozin (Jardiance, Boehringer Ingelheim/Lilly) for children as young as 10 years.

“I look forward to prescribing empagliflozin to children with type 2 diabetes to lower their blood pressure and get additional cardiovascular disease benefits,” Dr. Gandica said.

Other newer type 2 diabetes medications approved for U.S. children in the past few years include the once-weekly injectable GLP-1 agonist exenatide extended release (Bydureon/Bydureon BCise, AstraZeneca) for children with type 2 diabetes aged 10 and older, in 2021, and the daily injectable GLP-1 agonist liraglutide (Victoza, Novo Nordisk) in 2019.
 

A1c spike heralds treatment failure: ‘Watch for that’

TODAY enrolled 699 children with type 2 diabetes for an average of 8 months since diagnosis at 16 U.S. sites starting in 2004. The protocol began with a run-in phase of up to 6 months, when participating children came off any preexisting antidiabetes medications and then began a metformin-only regimen to bring A1c below 8.0%. If achieved, patients were eligible to continue to randomization.

Participants were randomized to one of three treatment groups: metformin alone, metformin plus lifestyle interventions, or metformin plus rosiglitazone (Avandia, GSK). The primary endpoint was the incidence of treatment failure, defined as A1c that rose back above 8.0% for at least 6 months or persistent metabolic decompensation during initial follow-up, for an average of just under 4 years.

The results showed that only metformin plus rosiglitazone significantly surpassed metformin alone for preventing treatment failure, reported in 2012 in the New England Journal of Medicine

More recent reports on findings from longer-term follow-up have appeared in several journals, including the cardiovascular disease results, reported in 2021 also in the New England Journal of Medicine.

Another key finding from TODAY is the importance of A1c as a risk marker for impending treatment failure. Study findingsshow that an A1c of 6.2% or higher when children entered the study best predicted loss of glycemic control during follow-up. Also, a rise in A1c of at least 0.5 percentage points was significantly associated with loss of glycemic control within the following 3-6 months.

That’s an important message for clinicians, Dr. Gandica concluded.

TODAY and TODAY2 received no commercial funding. Dr. Gandica has reported no relevant financial relationships.

A version of this article originally appeared on Medscape.com.

The Food and Drug Administration approved ritlecitinib on June 23 for the treatment of severe alopecia areata in people ages 12 and older, the manufacturer announced.

Taken as a once-daily pill, ritlecitinib is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3 (JAK3). The recommended dose of ritlecitinib, which will be marketed as Litfulo, is 50 mg once a day, according to the statement announcing the approval from Pfizer.

Olivier Le Moal/Getty Images

It is the second JAK inhibitor approved for treating alopecia areata, following approval of baricitinib (Olumiant) in June 2022 for AA in adults. Ritlecitinib is the first JAK inhibitor approved for children ages 12 and older with AA.  

The European Medicines Agency has also accepted the Marketing Authorization Application for ritlecitinib in the same population and a decision is expected in the fourth quarter of this year.
 

Approval based on ALLEGRO trials

Approval was based on  previously announced results from trials, including the phase 2b/3 ALLEGRO study of ritlecitinib in 718 patients aged 12 years and older with alopecia areata, with 50% of more scalp hair loss, as measured by the Severity of Alopecia Tool (SALT), including patients with alopecia totalis (complete scalp hair loss) and alopecia universalis (complete scalp, face, and body hair loss).

Patients in the trial were experiencing a current episode of alopecia areata that had lasted between 6 months and 10 years. They were randomized to receive once-daily ritlecitinib at doses of 30 mg or 50 mg (with or without 1 month of initial treatment with once-daily ritlecitinib 200 mg), ritlecitinib 10 mg, or placebo.

Statistically significantly higher proportions of patients treated with ritlecitinib 30 mg and 50 mg (with or without the loading dose) had 80% or more scalp hair coverage, as measured by a SALT score of 20 or less after 6 months of treatment versus placebo. After 6 months of treatment, among those on the 50-mg dose, 23% had achieved a SALT score of 20 or less, compared with 2% of those on placebo. The results were published in The Lancet.

According to the company release, efficacy and safety of ritlecitinib was consistent between those ages 12-17 and adults, and the most common adverse events reported in the study, in at least 4% of patients treated with ritlecitinib, were headache (10.8%), diarrhea (10%), acne (6.2%), rash (5.4%), and urticaria (4.6%). 

Ritlecitinib labeling includes the boxed warning about the risk for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, which is included in the labels for other JAK inhibitors.
 

Ritlecitinib evaluated for other diseases

In addition to alopecia areata, ritlecitinib has shown efficacy and acceptable safety in treating ulcerative colitis and is being evaluated for treating vitiligo, Crohn’s disease, and rheumatoid arthritis.

In the statement, the company says that ritlecitinib will be available “in the coming weeks.” The manufacturer says it also has completed regulatory submissions for ritlecitinib in the United Kingdom, China, and Japan, and expects decisions this year.

Alopecia areata affects about 6.8 million people in the United States and 147 million globally.

In a statement, Nicole Friedland, president and CEO of the National Alopecia Areata Foundation, said that NAAF “is thrilled to have a second FDA-approved treatment for alopecia areata, which is the first approved for adolescents.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration approved ritlecitinib on June 23 for the treatment of severe alopecia areata in people ages 12 and older, the manufacturer announced.

Taken as a once-daily pill, ritlecitinib is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3 (JAK3). The recommended dose of ritlecitinib, which will be marketed as Litfulo, is 50 mg once a day, according to the statement announcing the approval from Pfizer.

Olivier Le Moal/Getty Images

It is the second JAK inhibitor approved for treating alopecia areata, following approval of baricitinib (Olumiant) in June 2022 for AA in adults. Ritlecitinib is the first JAK inhibitor approved for children ages 12 and older with AA.  

The European Medicines Agency has also accepted the Marketing Authorization Application for ritlecitinib in the same population and a decision is expected in the fourth quarter of this year.
 

Approval based on ALLEGRO trials

Approval was based on  previously announced results from trials, including the phase 2b/3 ALLEGRO study of ritlecitinib in 718 patients aged 12 years and older with alopecia areata, with 50% of more scalp hair loss, as measured by the Severity of Alopecia Tool (SALT), including patients with alopecia totalis (complete scalp hair loss) and alopecia universalis (complete scalp, face, and body hair loss).

Patients in the trial were experiencing a current episode of alopecia areata that had lasted between 6 months and 10 years. They were randomized to receive once-daily ritlecitinib at doses of 30 mg or 50 mg (with or without 1 month of initial treatment with once-daily ritlecitinib 200 mg), ritlecitinib 10 mg, or placebo.

Statistically significantly higher proportions of patients treated with ritlecitinib 30 mg and 50 mg (with or without the loading dose) had 80% or more scalp hair coverage, as measured by a SALT score of 20 or less after 6 months of treatment versus placebo. After 6 months of treatment, among those on the 50-mg dose, 23% had achieved a SALT score of 20 or less, compared with 2% of those on placebo. The results were published in The Lancet.

According to the company release, efficacy and safety of ritlecitinib was consistent between those ages 12-17 and adults, and the most common adverse events reported in the study, in at least 4% of patients treated with ritlecitinib, were headache (10.8%), diarrhea (10%), acne (6.2%), rash (5.4%), and urticaria (4.6%). 

Ritlecitinib labeling includes the boxed warning about the risk for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, which is included in the labels for other JAK inhibitors.
 

Ritlecitinib evaluated for other diseases

In addition to alopecia areata, ritlecitinib has shown efficacy and acceptable safety in treating ulcerative colitis and is being evaluated for treating vitiligo, Crohn’s disease, and rheumatoid arthritis.

In the statement, the company says that ritlecitinib will be available “in the coming weeks.” The manufacturer says it also has completed regulatory submissions for ritlecitinib in the United Kingdom, China, and Japan, and expects decisions this year.

Alopecia areata affects about 6.8 million people in the United States and 147 million globally.

In a statement, Nicole Friedland, president and CEO of the National Alopecia Areata Foundation, said that NAAF “is thrilled to have a second FDA-approved treatment for alopecia areata, which is the first approved for adolescents.”

A version of this article first appeared on Medscape.com.

The Food and Drug Administration approved ritlecitinib on June 23 for the treatment of severe alopecia areata in people ages 12 and older, the manufacturer announced.

Taken as a once-daily pill, ritlecitinib is a dual inhibitor of the TEC family of tyrosine kinases and of Janus kinase 3 (JAK3). The recommended dose of ritlecitinib, which will be marketed as Litfulo, is 50 mg once a day, according to the statement announcing the approval from Pfizer.

Olivier Le Moal/Getty Images

It is the second JAK inhibitor approved for treating alopecia areata, following approval of baricitinib (Olumiant) in June 2022 for AA in adults. Ritlecitinib is the first JAK inhibitor approved for children ages 12 and older with AA.  

The European Medicines Agency has also accepted the Marketing Authorization Application for ritlecitinib in the same population and a decision is expected in the fourth quarter of this year.
 

Approval based on ALLEGRO trials

Approval was based on  previously announced results from trials, including the phase 2b/3 ALLEGRO study of ritlecitinib in 718 patients aged 12 years and older with alopecia areata, with 50% of more scalp hair loss, as measured by the Severity of Alopecia Tool (SALT), including patients with alopecia totalis (complete scalp hair loss) and alopecia universalis (complete scalp, face, and body hair loss).

Patients in the trial were experiencing a current episode of alopecia areata that had lasted between 6 months and 10 years. They were randomized to receive once-daily ritlecitinib at doses of 30 mg or 50 mg (with or without 1 month of initial treatment with once-daily ritlecitinib 200 mg), ritlecitinib 10 mg, or placebo.

Statistically significantly higher proportions of patients treated with ritlecitinib 30 mg and 50 mg (with or without the loading dose) had 80% or more scalp hair coverage, as measured by a SALT score of 20 or less after 6 months of treatment versus placebo. After 6 months of treatment, among those on the 50-mg dose, 23% had achieved a SALT score of 20 or less, compared with 2% of those on placebo. The results were published in The Lancet.

According to the company release, efficacy and safety of ritlecitinib was consistent between those ages 12-17 and adults, and the most common adverse events reported in the study, in at least 4% of patients treated with ritlecitinib, were headache (10.8%), diarrhea (10%), acne (6.2%), rash (5.4%), and urticaria (4.6%). 

Ritlecitinib labeling includes the boxed warning about the risk for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis, which is included in the labels for other JAK inhibitors.
 

Ritlecitinib evaluated for other diseases

In addition to alopecia areata, ritlecitinib has shown efficacy and acceptable safety in treating ulcerative colitis and is being evaluated for treating vitiligo, Crohn’s disease, and rheumatoid arthritis.

In the statement, the company says that ritlecitinib will be available “in the coming weeks.” The manufacturer says it also has completed regulatory submissions for ritlecitinib in the United Kingdom, China, and Japan, and expects decisions this year.

Alopecia areata affects about 6.8 million people in the United States and 147 million globally.

In a statement, Nicole Friedland, president and CEO of the National Alopecia Areata Foundation, said that NAAF “is thrilled to have a second FDA-approved treatment for alopecia areata, which is the first approved for adolescents.”

A version of this article first appeared on Medscape.com.

Controversies remain in treating inguinal hernias in children and the American Academy of Pediatrics is addressing them with a clinical report.

Faraz A. Khan, MD, an adjunct associate professor in the division of pediatric surgery at Loma Linda (Calif.) University Children’s Hospital, led the AAP’s Committee on Fetus and Newborn, sections on surgery and urology, in writing the guidance, published in Pediatrics.

An inguinal hernia, a common pediatric surgical condition (90% are in boys, the authors wrote), appears as a bulge in the groin or scrotum and requires surgical repair to prevent a more severe incarcerated hernia, which occurs when organs from the abdomen become trapped in the hernia.

The risk of that incarceration drives the preference and timing of surgical repair, the authors wrote.

The incidence of inguinal hernias is about 8-50 per 1,000 live births in term infants and is much higher in extremely low-birth-weight infants.

Ankush Gosain, MD, PhD, chief of pediatric surgery at Children’s Hospital Colorado, Aurora, who was not involved in the AAP clinical report, said in an interview that the best timing for the surgery on a premature infant has been an unanswered question and this guidance is helpful.

Inguinal hernias in preterm infants are especially common. The incidence is reported to be as high as 20%.

Repair can wait until babies have left NICU

The authors concluded that there was moderate-quality evidence supporting deferring hernia repair until after discharge from the neonatal intensive care unit because this may reduce the risk of respiratory problems without increasing risk of incarceration or another operation.

But Dr. Gosain noted that the authors left the door open for data from a study that recently finished enrolling patients. That trial (Dr. Gosain is a site investigator) is expected to help determine whether an early- or late-term approach is best in preterm infants.

“There are pluses and minuses that we and the neonatologists and the anesthesiologists recognize,” he said.
 

Laparoscopic approach as good, sometimes better

Dr. Gosain also said he was glad to see the authors addressed the merits of the laparoscopic approach and when it is preferred.

The authors noted that a laparoscopic approach is increasingly popular – rates have grown fivefold between 2009 and 2018 – and they found it is “at least as effective as, if not better than,” the current preferred method, traditional open high ligation of the hernia sac.

Laparoscopy also appears to be a feasible option in managing recurrent hernias.

Dr. Gosain said that, when the laparoscopic approach was developed, there was concern that it would lead to higher recurrence of the hernias. “That concern has diminished over time,” he added. The paper helps give surgeons and pediatricians peace of mind that this is a safe approach.
 

Who should perform the surgeries?

The authors concluded that, ideally, pediatric surgical specialists, pediatric urologists, or general surgeons with a significant yearly case volume should perform the surgeries.

They found a significant inverse relationship between recurrence rates and general surgeon case volume: general surgeons who completed fewer than 10 pediatric inguinal hernias per year had the highest recurrence rates and the highest-volume general surgeons had recurrence rates similar to pediatric surgical specialists.

Pediatric surgical specialists trained in fellowships had the lowest rate of hernia recurrences.

Dr. Gosain said he was glad the authors pointed out that both the surgeon and the anesthesiologist ideally should have that specialty training.
 

No evidence that anesthetic exposure affects neurodevelopment

The researchers found no conclusive evidence that otherwise-healthy children’s exposure to a single relatively short duration of anesthetic adds any significant risk to neurodevelopment or academic performance, or increases risk of ADHD or autism spectrum disorder.

Contralateral exploration with unilateral hernia

Providers continue to debate contralateral exploration among patients with unilateral inguinal hernia. Proponents of exploration cite a 10%-15% rate of developing of a hernia at a later time. Therefore, routine exploration and, if identified, ligation of a patent processus vaginalis (PPV) may avoid a subsequent anesthetic.

Opponents counter that not all PPVs will become clinically significant inguinal hernias, and doing routine exploration exposes the patient to potentially unnecessary complications.

The authors wrote: “In the absence of strong data for or against repair of incidentally discovered contralateral PPV, family values related to the risks and benefits of each approach from a nuanced preoperative discussion should be considered.”

Dr. Gosain said that, with all of the guidance points, “you need to have a true conversation between the surgeon and the parents with pluses and minuses of the different approaches because one is not necessarily absolutely better than the other.”

The authors and Dr. Gosain declare no relevant financial relationships.

Controversies remain in treating inguinal hernias in children and the American Academy of Pediatrics is addressing them with a clinical report.

Faraz A. Khan, MD, an adjunct associate professor in the division of pediatric surgery at Loma Linda (Calif.) University Children’s Hospital, led the AAP’s Committee on Fetus and Newborn, sections on surgery and urology, in writing the guidance, published in Pediatrics.

An inguinal hernia, a common pediatric surgical condition (90% are in boys, the authors wrote), appears as a bulge in the groin or scrotum and requires surgical repair to prevent a more severe incarcerated hernia, which occurs when organs from the abdomen become trapped in the hernia.

The risk of that incarceration drives the preference and timing of surgical repair, the authors wrote.

The incidence of inguinal hernias is about 8-50 per 1,000 live births in term infants and is much higher in extremely low-birth-weight infants.

Ankush Gosain, MD, PhD, chief of pediatric surgery at Children’s Hospital Colorado, Aurora, who was not involved in the AAP clinical report, said in an interview that the best timing for the surgery on a premature infant has been an unanswered question and this guidance is helpful.

Inguinal hernias in preterm infants are especially common. The incidence is reported to be as high as 20%.

Repair can wait until babies have left NICU

The authors concluded that there was moderate-quality evidence supporting deferring hernia repair until after discharge from the neonatal intensive care unit because this may reduce the risk of respiratory problems without increasing risk of incarceration or another operation.

But Dr. Gosain noted that the authors left the door open for data from a study that recently finished enrolling patients. That trial (Dr. Gosain is a site investigator) is expected to help determine whether an early- or late-term approach is best in preterm infants.

“There are pluses and minuses that we and the neonatologists and the anesthesiologists recognize,” he said.
 

Laparoscopic approach as good, sometimes better

Dr. Gosain also said he was glad to see the authors addressed the merits of the laparoscopic approach and when it is preferred.

The authors noted that a laparoscopic approach is increasingly popular – rates have grown fivefold between 2009 and 2018 – and they found it is “at least as effective as, if not better than,” the current preferred method, traditional open high ligation of the hernia sac.

Laparoscopy also appears to be a feasible option in managing recurrent hernias.

Dr. Gosain said that, when the laparoscopic approach was developed, there was concern that it would lead to higher recurrence of the hernias. “That concern has diminished over time,” he added. The paper helps give surgeons and pediatricians peace of mind that this is a safe approach.
 

Who should perform the surgeries?

The authors concluded that, ideally, pediatric surgical specialists, pediatric urologists, or general surgeons with a significant yearly case volume should perform the surgeries.

They found a significant inverse relationship between recurrence rates and general surgeon case volume: general surgeons who completed fewer than 10 pediatric inguinal hernias per year had the highest recurrence rates and the highest-volume general surgeons had recurrence rates similar to pediatric surgical specialists.

Pediatric surgical specialists trained in fellowships had the lowest rate of hernia recurrences.

Dr. Gosain said he was glad the authors pointed out that both the surgeon and the anesthesiologist ideally should have that specialty training.
 

No evidence that anesthetic exposure affects neurodevelopment

The researchers found no conclusive evidence that otherwise-healthy children’s exposure to a single relatively short duration of anesthetic adds any significant risk to neurodevelopment or academic performance, or increases risk of ADHD or autism spectrum disorder.

Contralateral exploration with unilateral hernia

Providers continue to debate contralateral exploration among patients with unilateral inguinal hernia. Proponents of exploration cite a 10%-15% rate of developing of a hernia at a later time. Therefore, routine exploration and, if identified, ligation of a patent processus vaginalis (PPV) may avoid a subsequent anesthetic.

Opponents counter that not all PPVs will become clinically significant inguinal hernias, and doing routine exploration exposes the patient to potentially unnecessary complications.

The authors wrote: “In the absence of strong data for or against repair of incidentally discovered contralateral PPV, family values related to the risks and benefits of each approach from a nuanced preoperative discussion should be considered.”

Dr. Gosain said that, with all of the guidance points, “you need to have a true conversation between the surgeon and the parents with pluses and minuses of the different approaches because one is not necessarily absolutely better than the other.”

The authors and Dr. Gosain declare no relevant financial relationships.

Controversies remain in treating inguinal hernias in children and the American Academy of Pediatrics is addressing them with a clinical report.

Faraz A. Khan, MD, an adjunct associate professor in the division of pediatric surgery at Loma Linda (Calif.) University Children’s Hospital, led the AAP’s Committee on Fetus and Newborn, sections on surgery and urology, in writing the guidance, published in Pediatrics.

An inguinal hernia, a common pediatric surgical condition (90% are in boys, the authors wrote), appears as a bulge in the groin or scrotum and requires surgical repair to prevent a more severe incarcerated hernia, which occurs when organs from the abdomen become trapped in the hernia.

The risk of that incarceration drives the preference and timing of surgical repair, the authors wrote.

The incidence of inguinal hernias is about 8-50 per 1,000 live births in term infants and is much higher in extremely low-birth-weight infants.

Ankush Gosain, MD, PhD, chief of pediatric surgery at Children’s Hospital Colorado, Aurora, who was not involved in the AAP clinical report, said in an interview that the best timing for the surgery on a premature infant has been an unanswered question and this guidance is helpful.

Inguinal hernias in preterm infants are especially common. The incidence is reported to be as high as 20%.

Repair can wait until babies have left NICU

The authors concluded that there was moderate-quality evidence supporting deferring hernia repair until after discharge from the neonatal intensive care unit because this may reduce the risk of respiratory problems without increasing risk of incarceration or another operation.

But Dr. Gosain noted that the authors left the door open for data from a study that recently finished enrolling patients. That trial (Dr. Gosain is a site investigator) is expected to help determine whether an early- or late-term approach is best in preterm infants.

“There are pluses and minuses that we and the neonatologists and the anesthesiologists recognize,” he said.
 

Laparoscopic approach as good, sometimes better

Dr. Gosain also said he was glad to see the authors addressed the merits of the laparoscopic approach and when it is preferred.

The authors noted that a laparoscopic approach is increasingly popular – rates have grown fivefold between 2009 and 2018 – and they found it is “at least as effective as, if not better than,” the current preferred method, traditional open high ligation of the hernia sac.

Laparoscopy also appears to be a feasible option in managing recurrent hernias.

Dr. Gosain said that, when the laparoscopic approach was developed, there was concern that it would lead to higher recurrence of the hernias. “That concern has diminished over time,” he added. The paper helps give surgeons and pediatricians peace of mind that this is a safe approach.
 

Who should perform the surgeries?

The authors concluded that, ideally, pediatric surgical specialists, pediatric urologists, or general surgeons with a significant yearly case volume should perform the surgeries.

They found a significant inverse relationship between recurrence rates and general surgeon case volume: general surgeons who completed fewer than 10 pediatric inguinal hernias per year had the highest recurrence rates and the highest-volume general surgeons had recurrence rates similar to pediatric surgical specialists.

Pediatric surgical specialists trained in fellowships had the lowest rate of hernia recurrences.

Dr. Gosain said he was glad the authors pointed out that both the surgeon and the anesthesiologist ideally should have that specialty training.
 

No evidence that anesthetic exposure affects neurodevelopment

The researchers found no conclusive evidence that otherwise-healthy children’s exposure to a single relatively short duration of anesthetic adds any significant risk to neurodevelopment or academic performance, or increases risk of ADHD or autism spectrum disorder.

Contralateral exploration with unilateral hernia

Providers continue to debate contralateral exploration among patients with unilateral inguinal hernia. Proponents of exploration cite a 10%-15% rate of developing of a hernia at a later time. Therefore, routine exploration and, if identified, ligation of a patent processus vaginalis (PPV) may avoid a subsequent anesthetic.

Opponents counter that not all PPVs will become clinically significant inguinal hernias, and doing routine exploration exposes the patient to potentially unnecessary complications.

The authors wrote: “In the absence of strong data for or against repair of incidentally discovered contralateral PPV, family values related to the risks and benefits of each approach from a nuanced preoperative discussion should be considered.”

Dr. Gosain said that, with all of the guidance points, “you need to have a true conversation between the surgeon and the parents with pluses and minuses of the different approaches because one is not necessarily absolutely better than the other.”

The authors and Dr. Gosain declare no relevant financial relationships.

The American Academy of Pediatrics (AAP) Council on Injury, Violence, and Poison Prevention has released a new policy statement outlining how pediatricians can improve child pedestrian safety by educating families as well as engaging in legislative advocacy to make communities more pedestrian friendly.

The policy statement recommends that pediatricians advocate for environmental and urban planning that aims for no pedestrian fatalities or serious injuries, according to authors Sadiqa A. I. Kendi, MD, MPH, CPST; and Brian D. Johnston, MD, MPH, and colleagues.

While pedestrian fatalities have declined over the last 3 decades, child pedestrian fatalities have increased by 11% since 2013, the AAP Council on Injury, Violence, and Poison Prevention noted. Many of these fatalities occur in rural areas, during 6 to 9 p.m., mid-block rather than at intersections, and among adolescents aged 10-19 years, according to statistics from the National Highway Traffic Safety Administration.

“The reminder to ‘Look both ways before you cross the street,’ is good advice, but just part of the equation,” Dr. Kendi stated in a press release. “Research tells us that an even more effective way to consistently improve safety is when communities take intentional steps to create pedestrian-safe environments. We live in a busy, distracted world, and when local leaders create walkable spaces, they also enhance the appeal and vibrance of their communities.”
 

Advocating for safer communities

The AAP’s policy statement recommends that pediatricians advocate for legislation at the federal, state, and local level that supports a “Complete Streets” policy of including all forms of transportation and people on the roadways as well as incorporates a “Vision Zero” policy of reducing traffic fatalities and injuries. Other recommendations include supporting legislation that reduces speeds in urban areas, and the use of photo speed limit enforcement in areas such as school zones.

The AAP also highlighted the need for the adoption of new safety technology such as pedestrian detection systems, automatic braking in vehicles, and the consideration of child pedestrians with the development of new technologies such as autonomous vehicles.

“Drivers may not see small children when backing up their vehicles in a driveway or lot,” Dr. Kendi said. “Newer and self-driving vehicles are increasingly equipped with safety features and technology to detect pedestrians and avoid crashes, but they’re often more likely to detect adults and may not be able to account for the less predictable movements of a small child.”

In addition, the AAP’s policy statement recommends that pediatricians participate in community advocacy for safer and healthier pedestrian environments, community-level Vision Zero interventions, development of safe routes to school, alternative nonmotorized transportation methods to reduce vehicular traffic, the development of pedestrian infrastructure in communities, 20-mph zones in residential and commercial areas, research into pedestrian education, and surveillance systems that could identify locations where pedestrian injury is a high risk.
 

Educating families on pedestrian safety

There is also an opportunity to engage in anticipatory guidance with children and their parents, according to the policy statement. The AAP recommends pediatricians counsel families on the complexity of the traffic environment, remind parents that children may not be visible to drivers, and that driveways and unfenced yards are considered unsafe play areas. Adults should be with children aged younger than 10 years and teach young children the importance of pedestrian safety based on the child’s developmental level, the AAP said. When children are older, they can be more independent, but should still use “protected routes with signalized crossings in low-traffic environments,” they noted.

For parents of children with limited mobility or another disability, extra time may be needed to help children safely navigate a pedestrian environment, the AAP explained. “This might include selection of routes with low barriers to mobility, interventions to increase pedestrian visibility, instruction on use of audible pedestrian signals, and white-cane skills for children with visual impairment,” they noted.

All children should be educated on the risk of distracted walking, whether through texting, talking on the phone, or listening to music.

“We know that active transportation, like walking or biking, is good for kids and it’s good for the environment,” Brian D. Johnston, MD, MPH, coauthor of the report, said in a press release. “As children grow older, they will be able to be more independent. Each of us can help keep children safe by paying attention to the people around us and by promoting safer environments that benefit all of us.”
 

‘Pediatricians always find a way to reach their patients’

In an interview, Christina Johns, MD, MEd, pediatric emergency doctor and senior medical adviser at PM Pediatric Care, said that implementing this policy statement “requires a multilayered approach” that includes funding infrastructure and city planning, policy changes, family education, and other stakeholders and “will require support and buy-in at all levels.”

“While challenging to implement, the return in potential lives saved and additional health benefits of increased mobility for children (decreasing obesity burden, for example) cannot be overstated,” Dr. Johns said. “It will be helpful to create a checklist of the recommended counseling points that can be added to health records to keep this topic top of mind and document that it has been discussed at well visits.”

Emma Sartin, PhD, MPH, a research scientist at the Center for Injury Research and Prevention at Children’s Hospital of Philadelphia, said environmental risks will still be present regardless of whether a child is a safe pedestrian. “Adults and children need to balance practical safe mobility behavior with being present and aware in the current moment; as a pedestrian, without the protection of active and passive safety systems in motor vehicles, staying vigilant is critical to safety,” she said. Many pedestrian injuries and fatalities come from marginalized racial and ethnic groups, and those with neurodivergent statuses, Dr. Sartin explained, who “get licensed later than their peers, which may make being a pedestrian or using other modes of transportation (such as cycling) necessary.”

“These groups also often have higher rates of crash injuries and fatalities when they are inside of vehicles,” she said. “We need to be better at supporting safe mobility across different transportation options – driving, walking, cycling, and public transit – for all children and adults.”

Pediatricians excel at using anticipatory guidance to counsel families, and the refinements in the latest AAP policy statement on child pedestrian safety are something pediatricians can focus on at well visits, Dr. Johns said. Specific age groups will require pediatricians to adjust their conversation based on the child’s development as well as the family’s questions and concerns, she noted.

Dorothy Novick, MD, a pediatrician at Children’s Hospital of Philadelphia, said guidance to families will change as a child grows and develops, starting with teaching young children to hold hands when crossing the street, and not to play near driveways and roads.

“As children grow older, I remind families what I myself was surprised to learn as a new parent – that most children don’t develop the depth perception, judgment, and motor skills they need to cross the street safely by themselves until they’re at least 10 years old,” she explained. “Of course, with teens we place enormous emphasis on avoiding distractions, such as texting and watching videos while walking. One message remains the same for all parents, no matter the child’s age – the importance of modeling safe pedestrian behavior.

“Even during busy annual checkups, pediatricians always find a way to reach their patients and families about topics important to child health and wellness, so I have confidence that my colleagues and I will execute this mission,” Dr. Johns said. “The time required for advocacy and lobbying can be challenging however, and so having advocacy groups like the AAP is key to creating agency for pediatricians to have a voice in their communities and the legislature.

“Children cannot speak or advocate for themselves when it comes to funding, development of social programs or safety policy, or infrastructure planning and building, so it’s up to pediatricians to have a loud and unified voice to make sure that we watch out for their safety and incorporate their unique needs into their surroundings as much as possible,” she added.

The AAP reports that it has not accepted commercial involvement in developing the policy statement, and all authors have resolved potential conflicts of interest through a process approved by the AAP board of directors. Dr. Johns, Dr. Novick, and Dr. Sartin report no relevant financial disclosures.

The American Academy of Pediatrics (AAP) Council on Injury, Violence, and Poison Prevention has released a new policy statement outlining how pediatricians can improve child pedestrian safety by educating families as well as engaging in legislative advocacy to make communities more pedestrian friendly.

The policy statement recommends that pediatricians advocate for environmental and urban planning that aims for no pedestrian fatalities or serious injuries, according to authors Sadiqa A. I. Kendi, MD, MPH, CPST; and Brian D. Johnston, MD, MPH, and colleagues.

While pedestrian fatalities have declined over the last 3 decades, child pedestrian fatalities have increased by 11% since 2013, the AAP Council on Injury, Violence, and Poison Prevention noted. Many of these fatalities occur in rural areas, during 6 to 9 p.m., mid-block rather than at intersections, and among adolescents aged 10-19 years, according to statistics from the National Highway Traffic Safety Administration.

“The reminder to ‘Look both ways before you cross the street,’ is good advice, but just part of the equation,” Dr. Kendi stated in a press release. “Research tells us that an even more effective way to consistently improve safety is when communities take intentional steps to create pedestrian-safe environments. We live in a busy, distracted world, and when local leaders create walkable spaces, they also enhance the appeal and vibrance of their communities.”
 

Advocating for safer communities

The AAP’s policy statement recommends that pediatricians advocate for legislation at the federal, state, and local level that supports a “Complete Streets” policy of including all forms of transportation and people on the roadways as well as incorporates a “Vision Zero” policy of reducing traffic fatalities and injuries. Other recommendations include supporting legislation that reduces speeds in urban areas, and the use of photo speed limit enforcement in areas such as school zones.

The AAP also highlighted the need for the adoption of new safety technology such as pedestrian detection systems, automatic braking in vehicles, and the consideration of child pedestrians with the development of new technologies such as autonomous vehicles.

“Drivers may not see small children when backing up their vehicles in a driveway or lot,” Dr. Kendi said. “Newer and self-driving vehicles are increasingly equipped with safety features and technology to detect pedestrians and avoid crashes, but they’re often more likely to detect adults and may not be able to account for the less predictable movements of a small child.”

In addition, the AAP’s policy statement recommends that pediatricians participate in community advocacy for safer and healthier pedestrian environments, community-level Vision Zero interventions, development of safe routes to school, alternative nonmotorized transportation methods to reduce vehicular traffic, the development of pedestrian infrastructure in communities, 20-mph zones in residential and commercial areas, research into pedestrian education, and surveillance systems that could identify locations where pedestrian injury is a high risk.
 

Educating families on pedestrian safety

There is also an opportunity to engage in anticipatory guidance with children and their parents, according to the policy statement. The AAP recommends pediatricians counsel families on the complexity of the traffic environment, remind parents that children may not be visible to drivers, and that driveways and unfenced yards are considered unsafe play areas. Adults should be with children aged younger than 10 years and teach young children the importance of pedestrian safety based on the child’s developmental level, the AAP said. When children are older, they can be more independent, but should still use “protected routes with signalized crossings in low-traffic environments,” they noted.

For parents of children with limited mobility or another disability, extra time may be needed to help children safely navigate a pedestrian environment, the AAP explained. “This might include selection of routes with low barriers to mobility, interventions to increase pedestrian visibility, instruction on use of audible pedestrian signals, and white-cane skills for children with visual impairment,” they noted.

All children should be educated on the risk of distracted walking, whether through texting, talking on the phone, or listening to music.

“We know that active transportation, like walking or biking, is good for kids and it’s good for the environment,” Brian D. Johnston, MD, MPH, coauthor of the report, said in a press release. “As children grow older, they will be able to be more independent. Each of us can help keep children safe by paying attention to the people around us and by promoting safer environments that benefit all of us.”
 

‘Pediatricians always find a way to reach their patients’

In an interview, Christina Johns, MD, MEd, pediatric emergency doctor and senior medical adviser at PM Pediatric Care, said that implementing this policy statement “requires a multilayered approach” that includes funding infrastructure and city planning, policy changes, family education, and other stakeholders and “will require support and buy-in at all levels.”

“While challenging to implement, the return in potential lives saved and additional health benefits of increased mobility for children (decreasing obesity burden, for example) cannot be overstated,” Dr. Johns said. “It will be helpful to create a checklist of the recommended counseling points that can be added to health records to keep this topic top of mind and document that it has been discussed at well visits.”

Emma Sartin, PhD, MPH, a research scientist at the Center for Injury Research and Prevention at Children’s Hospital of Philadelphia, said environmental risks will still be present regardless of whether a child is a safe pedestrian. “Adults and children need to balance practical safe mobility behavior with being present and aware in the current moment; as a pedestrian, without the protection of active and passive safety systems in motor vehicles, staying vigilant is critical to safety,” she said. Many pedestrian injuries and fatalities come from marginalized racial and ethnic groups, and those with neurodivergent statuses, Dr. Sartin explained, who “get licensed later than their peers, which may make being a pedestrian or using other modes of transportation (such as cycling) necessary.”

“These groups also often have higher rates of crash injuries and fatalities when they are inside of vehicles,” she said. “We need to be better at supporting safe mobility across different transportation options – driving, walking, cycling, and public transit – for all children and adults.”

Pediatricians excel at using anticipatory guidance to counsel families, and the refinements in the latest AAP policy statement on child pedestrian safety are something pediatricians can focus on at well visits, Dr. Johns said. Specific age groups will require pediatricians to adjust their conversation based on the child’s development as well as the family’s questions and concerns, she noted.

Dorothy Novick, MD, a pediatrician at Children’s Hospital of Philadelphia, said guidance to families will change as a child grows and develops, starting with teaching young children to hold hands when crossing the street, and not to play near driveways and roads.

“As children grow older, I remind families what I myself was surprised to learn as a new parent – that most children don’t develop the depth perception, judgment, and motor skills they need to cross the street safely by themselves until they’re at least 10 years old,” she explained. “Of course, with teens we place enormous emphasis on avoiding distractions, such as texting and watching videos while walking. One message remains the same for all parents, no matter the child’s age – the importance of modeling safe pedestrian behavior.

“Even during busy annual checkups, pediatricians always find a way to reach their patients and families about topics important to child health and wellness, so I have confidence that my colleagues and I will execute this mission,” Dr. Johns said. “The time required for advocacy and lobbying can be challenging however, and so having advocacy groups like the AAP is key to creating agency for pediatricians to have a voice in their communities and the legislature.

“Children cannot speak or advocate for themselves when it comes to funding, development of social programs or safety policy, or infrastructure planning and building, so it’s up to pediatricians to have a loud and unified voice to make sure that we watch out for their safety and incorporate their unique needs into their surroundings as much as possible,” she added.

The AAP reports that it has not accepted commercial involvement in developing the policy statement, and all authors have resolved potential conflicts of interest through a process approved by the AAP board of directors. Dr. Johns, Dr. Novick, and Dr. Sartin report no relevant financial disclosures.

The American Academy of Pediatrics (AAP) Council on Injury, Violence, and Poison Prevention has released a new policy statement outlining how pediatricians can improve child pedestrian safety by educating families as well as engaging in legislative advocacy to make communities more pedestrian friendly.

The policy statement recommends that pediatricians advocate for environmental and urban planning that aims for no pedestrian fatalities or serious injuries, according to authors Sadiqa A. I. Kendi, MD, MPH, CPST; and Brian D. Johnston, MD, MPH, and colleagues.

While pedestrian fatalities have declined over the last 3 decades, child pedestrian fatalities have increased by 11% since 2013, the AAP Council on Injury, Violence, and Poison Prevention noted. Many of these fatalities occur in rural areas, during 6 to 9 p.m., mid-block rather than at intersections, and among adolescents aged 10-19 years, according to statistics from the National Highway Traffic Safety Administration.

“The reminder to ‘Look both ways before you cross the street,’ is good advice, but just part of the equation,” Dr. Kendi stated in a press release. “Research tells us that an even more effective way to consistently improve safety is when communities take intentional steps to create pedestrian-safe environments. We live in a busy, distracted world, and when local leaders create walkable spaces, they also enhance the appeal and vibrance of their communities.”
 

Advocating for safer communities

The AAP’s policy statement recommends that pediatricians advocate for legislation at the federal, state, and local level that supports a “Complete Streets” policy of including all forms of transportation and people on the roadways as well as incorporates a “Vision Zero” policy of reducing traffic fatalities and injuries. Other recommendations include supporting legislation that reduces speeds in urban areas, and the use of photo speed limit enforcement in areas such as school zones.

The AAP also highlighted the need for the adoption of new safety technology such as pedestrian detection systems, automatic braking in vehicles, and the consideration of child pedestrians with the development of new technologies such as autonomous vehicles.

“Drivers may not see small children when backing up their vehicles in a driveway or lot,” Dr. Kendi said. “Newer and self-driving vehicles are increasingly equipped with safety features and technology to detect pedestrians and avoid crashes, but they’re often more likely to detect adults and may not be able to account for the less predictable movements of a small child.”

In addition, the AAP’s policy statement recommends that pediatricians participate in community advocacy for safer and healthier pedestrian environments, community-level Vision Zero interventions, development of safe routes to school, alternative nonmotorized transportation methods to reduce vehicular traffic, the development of pedestrian infrastructure in communities, 20-mph zones in residential and commercial areas, research into pedestrian education, and surveillance systems that could identify locations where pedestrian injury is a high risk.
 

Educating families on pedestrian safety

There is also an opportunity to engage in anticipatory guidance with children and their parents, according to the policy statement. The AAP recommends pediatricians counsel families on the complexity of the traffic environment, remind parents that children may not be visible to drivers, and that driveways and unfenced yards are considered unsafe play areas. Adults should be with children aged younger than 10 years and teach young children the importance of pedestrian safety based on the child’s developmental level, the AAP said. When children are older, they can be more independent, but should still use “protected routes with signalized crossings in low-traffic environments,” they noted.

For parents of children with limited mobility or another disability, extra time may be needed to help children safely navigate a pedestrian environment, the AAP explained. “This might include selection of routes with low barriers to mobility, interventions to increase pedestrian visibility, instruction on use of audible pedestrian signals, and white-cane skills for children with visual impairment,” they noted.

All children should be educated on the risk of distracted walking, whether through texting, talking on the phone, or listening to music.

“We know that active transportation, like walking or biking, is good for kids and it’s good for the environment,” Brian D. Johnston, MD, MPH, coauthor of the report, said in a press release. “As children grow older, they will be able to be more independent. Each of us can help keep children safe by paying attention to the people around us and by promoting safer environments that benefit all of us.”
 

‘Pediatricians always find a way to reach their patients’

In an interview, Christina Johns, MD, MEd, pediatric emergency doctor and senior medical adviser at PM Pediatric Care, said that implementing this policy statement “requires a multilayered approach” that includes funding infrastructure and city planning, policy changes, family education, and other stakeholders and “will require support and buy-in at all levels.”

“While challenging to implement, the return in potential lives saved and additional health benefits of increased mobility for children (decreasing obesity burden, for example) cannot be overstated,” Dr. Johns said. “It will be helpful to create a checklist of the recommended counseling points that can be added to health records to keep this topic top of mind and document that it has been discussed at well visits.”

Emma Sartin, PhD, MPH, a research scientist at the Center for Injury Research and Prevention at Children’s Hospital of Philadelphia, said environmental risks will still be present regardless of whether a child is a safe pedestrian. “Adults and children need to balance practical safe mobility behavior with being present and aware in the current moment; as a pedestrian, without the protection of active and passive safety systems in motor vehicles, staying vigilant is critical to safety,” she said. Many pedestrian injuries and fatalities come from marginalized racial and ethnic groups, and those with neurodivergent statuses, Dr. Sartin explained, who “get licensed later than their peers, which may make being a pedestrian or using other modes of transportation (such as cycling) necessary.”

“These groups also often have higher rates of crash injuries and fatalities when they are inside of vehicles,” she said. “We need to be better at supporting safe mobility across different transportation options – driving, walking, cycling, and public transit – for all children and adults.”

Pediatricians excel at using anticipatory guidance to counsel families, and the refinements in the latest AAP policy statement on child pedestrian safety are something pediatricians can focus on at well visits, Dr. Johns said. Specific age groups will require pediatricians to adjust their conversation based on the child’s development as well as the family’s questions and concerns, she noted.

Dorothy Novick, MD, a pediatrician at Children’s Hospital of Philadelphia, said guidance to families will change as a child grows and develops, starting with teaching young children to hold hands when crossing the street, and not to play near driveways and roads.

“As children grow older, I remind families what I myself was surprised to learn as a new parent – that most children don’t develop the depth perception, judgment, and motor skills they need to cross the street safely by themselves until they’re at least 10 years old,” she explained. “Of course, with teens we place enormous emphasis on avoiding distractions, such as texting and watching videos while walking. One message remains the same for all parents, no matter the child’s age – the importance of modeling safe pedestrian behavior.

“Even during busy annual checkups, pediatricians always find a way to reach their patients and families about topics important to child health and wellness, so I have confidence that my colleagues and I will execute this mission,” Dr. Johns said. “The time required for advocacy and lobbying can be challenging however, and so having advocacy groups like the AAP is key to creating agency for pediatricians to have a voice in their communities and the legislature.

“Children cannot speak or advocate for themselves when it comes to funding, development of social programs or safety policy, or infrastructure planning and building, so it’s up to pediatricians to have a loud and unified voice to make sure that we watch out for their safety and incorporate their unique needs into their surroundings as much as possible,” she added.

The AAP reports that it has not accepted commercial involvement in developing the policy statement, and all authors have resolved potential conflicts of interest through a process approved by the AAP board of directors. Dr. Johns, Dr. Novick, and Dr. Sartin report no relevant financial disclosures.

AUSTIN, TEX – Migraine treatment and prevention is challenging in any population, but some present even more difficulties. Pregnant women and pediatric patients are two such groups where physicians and patients may be hesitant to use drugs.

Neuromodulation devices are proven alternatives to medical interventions, and the remote electrical neuromodulation device Nerivio (Theranica) was cleared by the Food and Drug Administration for acute treatment of migraine patients aged 12 and over in 2021. In March 2023, the agency expanded the clearance to include prevention of migration in adolescents aged 12 and over as well as adults.

Two studies presented at the annual meeting of the American Headache Society showed the safety of the remote electrical neuromodulation device in pregnant women and efficacy as a preventive measure in adolescents in a real-world setting. The latter study yielded similar findings to adults and was used by FDA in its decision to expand the device’s indication in adolescents in 2023, according to Teshamae Monteith, MD, who presented the study at a poster session.

The device, worn on the arm, allows the user to modulate the intensity of the stimulation so that it activates nociceptive pain receptors, but not in a painful way. “Each [patient] raises the intensity until it feels strong, yet comfortable, and when that happens, they activate the nociceptive receptors and the arm sends a signal all the way back up to the brainstem, where the pain control area is. Activating it causes the release of neurotransmitters that inhibit pain. That inhibition is a global pain inhibition mechanism, which causes inhibition of the migraine pain, and also the symptoms associated with migraine like photophobia and vomiting,” said Alit Stark-Inbar, PhD, who presented the study of treatment of pregnant women during a poster session.
 

Declining treatment days over time in adolescents

Dr. Monteith’s team studied high-frequency remote electrical neuromodulation device use in adolescents who had migraine on 10 days or more per month. They also required at least three treatment days in months 2 and 3 to control for the possibility that patients might stop using the device because they couldn’t afford it or for some reason other than efficacy or because their migraines went away.

The study included 83 adolescents aged 12-17 (mean, 15.9 years, 89% female). In the first month of use, the mean number of migraine treatment days was 12.6, which dropped to 9.0 in month 2 (P < .001), and 7.4 in month 3 (P < .001 from month 2). At 2 hours after treatment, 61.9% had pain relief, 24.5% had freedom from pain, 67.4% had functional disability relief, and 41.3% had functional disability freedom.

“It parallels the findings of the randomized, sham-controlled study in adults. The safety profile was excellent with just one person complaining of minor discomfort of the arm that resolved after treatment. The combination of the exceedingly safe profile and the likelihood of efficacy based on using monthly migraine treatment days as a proxy, the FDA decided to clear this for an adolescent indication,” said Dr. Monteith, associate professor of clinical neurology and chief of the headache division at the University of Miami.

The device design is convenient, according to Dr. Monteith. “The arm is just an easy place to stimulate. It’s a wearable device, and it’s 45 minutes [of treatment] and it’s app controlled. You know adolescents like their technology. They can track their symptoms here, and there’s some biobehavioral power to this because they can do biobehavioral exercises in addition to receiving the simulation,” she said.

The fact that the device is discrete is also an advantage for adolescents in school. “You have to go to the nurse to get your medication versus a device, you can just put it on, it’s easy, no one sees it, and no one’s making fun of you,” said Dr. Monteith.
 

Advantages for adolescents

The device offers a useful alternative to medication, according to Alan M. Rapoport, MD, who was asked for comment on the adolescent study. “I’d rather not give medication and certainly not preventive medication to an adolescent,” he said. He noted that over-the-counter acute care migraine medications such as aspirin or acetaminophen and combination medications with caffeine, as well as prescription medications such as triptans, “all have possible side effects, and when used to an increased extent can even cause medication overuse headache, increasing the severity and frequency of headache and migraine days per month,” Dr. Rapoport said. Using an effective device with almost no side effects is preferable to any of these acute care medications, especially if there are several headaches a month,” he said. Some newer medications that block calcitonin gene-related peptide might be quite effective when they are approved for adolescents, and should have few adverse events, he added.

In the past, Dr. Rapoport has favored biofeedback training for acute and especially preventive treatment of migraine in adolescents. “[Remote electrical neuromodulation] seems to do just as well, children enjoy it, and it’s easier for a patient to do at home,” said Dr. Rapoport.

Biofeedback training is usually taught to patients by a PhD psychologist. Once the patients have been on the biofeedback equipment and learn the techniques, they can practice on their own at home without equipment. “This new device treatment using Nerivio for acute care and prevention of migraine in adults and children 12 and older, where they can easily apply the device in almost any situation, whether they are at home or possibly even in school or out and about, looks very promising,” said Dr. Rapoport. It is quite effective and has almost no adverse events, which is what you really want, especially for adolescents,” he said.

Also asked to comment on the study of remote electrical neuromodulation use in adolescents, Abraham Avi Ashkenazi, MD, director of the Headache Clinic at Shaare Zedek Medical Center in Jerusalem, who attended the session, was enthusiastic, and said he has begun using it in his own practice. “It shows that remote electrical neuromodulation can not only be effective for the acute migraine attack, but also has a potential preventive effect on future migraine attacks. [This] actually makes sense, because we know that the more migraine attacks a person has, the more likely they are to progress to a more chronic form of the disease,” he said in an interview.

Asked what distinguishes REN from other neuromodulation therapies such as vagus nerve stimulation or transcranial magnetic stimulation (TMS), Dr. Ashkenazi said: “It’s just a different way of modulating the brain system via a different mechanism. In both ways, though, the advantage is that there are literally no adverse effects, as opposed to drug treatment.”
 

An alternative during pregnancy

Adolescents aren’t the only population where there is reluctance to use medication. Physicians have been prescribing the device for pregnant women, who are reluctant to take medication due to concerns effects on the fetus. However, pregnant women were not included in the pivotal studies. “They expect it to be safe. This study was done in order to validate that assumption. We reached out to women who either used the device during pregnancy or women from the same database who started it using afterwards, but did not use it during the pregnancy,” said Dr. Stark-Inbar, vice president of medical information at Theranica.

The study included 140 women, 59 in the remote electrical neuromodulation device group and 81 controls. The primary endpoint was gestational age, which was 38 weeks and 5 days in the remote electrical neuromodulation device group and 39 weeks among controls (P = .150). There were no significant between-group differences with respect to newborn birth weight, miscarriage rate, preterm birth rate, birth defect rate, developmental milestone rate, or emergency department visit rate.

Dr. Monteith and Dr. Ashkenazi have no relevant financial disclosures. Dr. Rapoport advises AbbVie, Biohaven, Cala Health, Dr. Reddy’s, Pfizer, Satsuma, Teva Pharmaceutical Industries, and Theranica. He is on the speakers bureau of AbbVie, Dr. Reddy’s, Impel, Pfizer and Teva Pharmaceutical Industries. Dr. Rapoport is the editor-in-chief of Neurology Reviews and on the editorial board of CNS Drugs.

AUSTIN, TEX – Migraine treatment and prevention is challenging in any population, but some present even more difficulties. Pregnant women and pediatric patients are two such groups where physicians and patients may be hesitant to use drugs.

Neuromodulation devices are proven alternatives to medical interventions, and the remote electrical neuromodulation device Nerivio (Theranica) was cleared by the Food and Drug Administration for acute treatment of migraine patients aged 12 and over in 2021. In March 2023, the agency expanded the clearance to include prevention of migration in adolescents aged 12 and over as well as adults.

Two studies presented at the annual meeting of the American Headache Society showed the safety of the remote electrical neuromodulation device in pregnant women and efficacy as a preventive measure in adolescents in a real-world setting. The latter study yielded similar findings to adults and was used by FDA in its decision to expand the device’s indication in adolescents in 2023, according to Teshamae Monteith, MD, who presented the study at a poster session.

The device, worn on the arm, allows the user to modulate the intensity of the stimulation so that it activates nociceptive pain receptors, but not in a painful way. “Each [patient] raises the intensity until it feels strong, yet comfortable, and when that happens, they activate the nociceptive receptors and the arm sends a signal all the way back up to the brainstem, where the pain control area is. Activating it causes the release of neurotransmitters that inhibit pain. That inhibition is a global pain inhibition mechanism, which causes inhibition of the migraine pain, and also the symptoms associated with migraine like photophobia and vomiting,” said Alit Stark-Inbar, PhD, who presented the study of treatment of pregnant women during a poster session.
 

Declining treatment days over time in adolescents

Dr. Monteith’s team studied high-frequency remote electrical neuromodulation device use in adolescents who had migraine on 10 days or more per month. They also required at least three treatment days in months 2 and 3 to control for the possibility that patients might stop using the device because they couldn’t afford it or for some reason other than efficacy or because their migraines went away.

The study included 83 adolescents aged 12-17 (mean, 15.9 years, 89% female). In the first month of use, the mean number of migraine treatment days was 12.6, which dropped to 9.0 in month 2 (P < .001), and 7.4 in month 3 (P < .001 from month 2). At 2 hours after treatment, 61.9% had pain relief, 24.5% had freedom from pain, 67.4% had functional disability relief, and 41.3% had functional disability freedom.

“It parallels the findings of the randomized, sham-controlled study in adults. The safety profile was excellent with just one person complaining of minor discomfort of the arm that resolved after treatment. The combination of the exceedingly safe profile and the likelihood of efficacy based on using monthly migraine treatment days as a proxy, the FDA decided to clear this for an adolescent indication,” said Dr. Monteith, associate professor of clinical neurology and chief of the headache division at the University of Miami.

The device design is convenient, according to Dr. Monteith. “The arm is just an easy place to stimulate. It’s a wearable device, and it’s 45 minutes [of treatment] and it’s app controlled. You know adolescents like their technology. They can track their symptoms here, and there’s some biobehavioral power to this because they can do biobehavioral exercises in addition to receiving the simulation,” she said.

The fact that the device is discrete is also an advantage for adolescents in school. “You have to go to the nurse to get your medication versus a device, you can just put it on, it’s easy, no one sees it, and no one’s making fun of you,” said Dr. Monteith.
 

Advantages for adolescents

The device offers a useful alternative to medication, according to Alan M. Rapoport, MD, who was asked for comment on the adolescent study. “I’d rather not give medication and certainly not preventive medication to an adolescent,” he said. He noted that over-the-counter acute care migraine medications such as aspirin or acetaminophen and combination medications with caffeine, as well as prescription medications such as triptans, “all have possible side effects, and when used to an increased extent can even cause medication overuse headache, increasing the severity and frequency of headache and migraine days per month,” Dr. Rapoport said. Using an effective device with almost no side effects is preferable to any of these acute care medications, especially if there are several headaches a month,” he said. Some newer medications that block calcitonin gene-related peptide might be quite effective when they are approved for adolescents, and should have few adverse events, he added.

In the past, Dr. Rapoport has favored biofeedback training for acute and especially preventive treatment of migraine in adolescents. “[Remote electrical neuromodulation] seems to do just as well, children enjoy it, and it’s easier for a patient to do at home,” said Dr. Rapoport.

Biofeedback training is usually taught to patients by a PhD psychologist. Once the patients have been on the biofeedback equipment and learn the techniques, they can practice on their own at home without equipment. “This new device treatment using Nerivio for acute care and prevention of migraine in adults and children 12 and older, where they can easily apply the device in almost any situation, whether they are at home or possibly even in school or out and about, looks very promising,” said Dr. Rapoport. It is quite effective and has almost no adverse events, which is what you really want, especially for adolescents,” he said.

Also asked to comment on the study of remote electrical neuromodulation use in adolescents, Abraham Avi Ashkenazi, MD, director of the Headache Clinic at Shaare Zedek Medical Center in Jerusalem, who attended the session, was enthusiastic, and said he has begun using it in his own practice. “It shows that remote electrical neuromodulation can not only be effective for the acute migraine attack, but also has a potential preventive effect on future migraine attacks. [This] actually makes sense, because we know that the more migraine attacks a person has, the more likely they are to progress to a more chronic form of the disease,” he said in an interview.

Asked what distinguishes REN from other neuromodulation therapies such as vagus nerve stimulation or transcranial magnetic stimulation (TMS), Dr. Ashkenazi said: “It’s just a different way of modulating the brain system via a different mechanism. In both ways, though, the advantage is that there are literally no adverse effects, as opposed to drug treatment.”
 

An alternative during pregnancy

Adolescents aren’t the only population where there is reluctance to use medication. Physicians have been prescribing the device for pregnant women, who are reluctant to take medication due to concerns effects on the fetus. However, pregnant women were not included in the pivotal studies. “They expect it to be safe. This study was done in order to validate that assumption. We reached out to women who either used the device during pregnancy or women from the same database who started it using afterwards, but did not use it during the pregnancy,” said Dr. Stark-Inbar, vice president of medical information at Theranica.

The study included 140 women, 59 in the remote electrical neuromodulation device group and 81 controls. The primary endpoint was gestational age, which was 38 weeks and 5 days in the remote electrical neuromodulation device group and 39 weeks among controls (P = .150). There were no significant between-group differences with respect to newborn birth weight, miscarriage rate, preterm birth rate, birth defect rate, developmental milestone rate, or emergency department visit rate.

Dr. Monteith and Dr. Ashkenazi have no relevant financial disclosures. Dr. Rapoport advises AbbVie, Biohaven, Cala Health, Dr. Reddy’s, Pfizer, Satsuma, Teva Pharmaceutical Industries, and Theranica. He is on the speakers bureau of AbbVie, Dr. Reddy’s, Impel, Pfizer and Teva Pharmaceutical Industries. Dr. Rapoport is the editor-in-chief of Neurology Reviews and on the editorial board of CNS Drugs.

AUSTIN, TEX – Migraine treatment and prevention is challenging in any population, but some present even more difficulties. Pregnant women and pediatric patients are two such groups where physicians and patients may be hesitant to use drugs.

Neuromodulation devices are proven alternatives to medical interventions, and the remote electrical neuromodulation device Nerivio (Theranica) was cleared by the Food and Drug Administration for acute treatment of migraine patients aged 12 and over in 2021. In March 2023, the agency expanded the clearance to include prevention of migration in adolescents aged 12 and over as well as adults.

Two studies presented at the annual meeting of the American Headache Society showed the safety of the remote electrical neuromodulation device in pregnant women and efficacy as a preventive measure in adolescents in a real-world setting. The latter study yielded similar findings to adults and was used by FDA in its decision to expand the device’s indication in adolescents in 2023, according to Teshamae Monteith, MD, who presented the study at a poster session.

The device, worn on the arm, allows the user to modulate the intensity of the stimulation so that it activates nociceptive pain receptors, but not in a painful way. “Each [patient] raises the intensity until it feels strong, yet comfortable, and when that happens, they activate the nociceptive receptors and the arm sends a signal all the way back up to the brainstem, where the pain control area is. Activating it causes the release of neurotransmitters that inhibit pain. That inhibition is a global pain inhibition mechanism, which causes inhibition of the migraine pain, and also the symptoms associated with migraine like photophobia and vomiting,” said Alit Stark-Inbar, PhD, who presented the study of treatment of pregnant women during a poster session.
 

Declining treatment days over time in adolescents

Dr. Monteith’s team studied high-frequency remote electrical neuromodulation device use in adolescents who had migraine on 10 days or more per month. They also required at least three treatment days in months 2 and 3 to control for the possibility that patients might stop using the device because they couldn’t afford it or for some reason other than efficacy or because their migraines went away.

The study included 83 adolescents aged 12-17 (mean, 15.9 years, 89% female). In the first month of use, the mean number of migraine treatment days was 12.6, which dropped to 9.0 in month 2 (P < .001), and 7.4 in month 3 (P < .001 from month 2). At 2 hours after treatment, 61.9% had pain relief, 24.5% had freedom from pain, 67.4% had functional disability relief, and 41.3% had functional disability freedom.

“It parallels the findings of the randomized, sham-controlled study in adults. The safety profile was excellent with just one person complaining of minor discomfort of the arm that resolved after treatment. The combination of the exceedingly safe profile and the likelihood of efficacy based on using monthly migraine treatment days as a proxy, the FDA decided to clear this for an adolescent indication,” said Dr. Monteith, associate professor of clinical neurology and chief of the headache division at the University of Miami.

The device design is convenient, according to Dr. Monteith. “The arm is just an easy place to stimulate. It’s a wearable device, and it’s 45 minutes [of treatment] and it’s app controlled. You know adolescents like their technology. They can track their symptoms here, and there’s some biobehavioral power to this because they can do biobehavioral exercises in addition to receiving the simulation,” she said.

The fact that the device is discrete is also an advantage for adolescents in school. “You have to go to the nurse to get your medication versus a device, you can just put it on, it’s easy, no one sees it, and no one’s making fun of you,” said Dr. Monteith.
 

Advantages for adolescents

The device offers a useful alternative to medication, according to Alan M. Rapoport, MD, who was asked for comment on the adolescent study. “I’d rather not give medication and certainly not preventive medication to an adolescent,” he said. He noted that over-the-counter acute care migraine medications such as aspirin or acetaminophen and combination medications with caffeine, as well as prescription medications such as triptans, “all have possible side effects, and when used to an increased extent can even cause medication overuse headache, increasing the severity and frequency of headache and migraine days per month,” Dr. Rapoport said. Using an effective device with almost no side effects is preferable to any of these acute care medications, especially if there are several headaches a month,” he said. Some newer medications that block calcitonin gene-related peptide might be quite effective when they are approved for adolescents, and should have few adverse events, he added.

In the past, Dr. Rapoport has favored biofeedback training for acute and especially preventive treatment of migraine in adolescents. “[Remote electrical neuromodulation] seems to do just as well, children enjoy it, and it’s easier for a patient to do at home,” said Dr. Rapoport.

Biofeedback training is usually taught to patients by a PhD psychologist. Once the patients have been on the biofeedback equipment and learn the techniques, they can practice on their own at home without equipment. “This new device treatment using Nerivio for acute care and prevention of migraine in adults and children 12 and older, where they can easily apply the device in almost any situation, whether they are at home or possibly even in school or out and about, looks very promising,” said Dr. Rapoport. It is quite effective and has almost no adverse events, which is what you really want, especially for adolescents,” he said.

Also asked to comment on the study of remote electrical neuromodulation use in adolescents, Abraham Avi Ashkenazi, MD, director of the Headache Clinic at Shaare Zedek Medical Center in Jerusalem, who attended the session, was enthusiastic, and said he has begun using it in his own practice. “It shows that remote electrical neuromodulation can not only be effective for the acute migraine attack, but also has a potential preventive effect on future migraine attacks. [This] actually makes sense, because we know that the more migraine attacks a person has, the more likely they are to progress to a more chronic form of the disease,” he said in an interview.

Asked what distinguishes REN from other neuromodulation therapies such as vagus nerve stimulation or transcranial magnetic stimulation (TMS), Dr. Ashkenazi said: “It’s just a different way of modulating the brain system via a different mechanism. In both ways, though, the advantage is that there are literally no adverse effects, as opposed to drug treatment.”
 

An alternative during pregnancy

Adolescents aren’t the only population where there is reluctance to use medication. Physicians have been prescribing the device for pregnant women, who are reluctant to take medication due to concerns effects on the fetus. However, pregnant women were not included in the pivotal studies. “They expect it to be safe. This study was done in order to validate that assumption. We reached out to women who either used the device during pregnancy or women from the same database who started it using afterwards, but did not use it during the pregnancy,” said Dr. Stark-Inbar, vice president of medical information at Theranica.

The study included 140 women, 59 in the remote electrical neuromodulation device group and 81 controls. The primary endpoint was gestational age, which was 38 weeks and 5 days in the remote electrical neuromodulation device group and 39 weeks among controls (P = .150). There were no significant between-group differences with respect to newborn birth weight, miscarriage rate, preterm birth rate, birth defect rate, developmental milestone rate, or emergency department visit rate.

Dr. Monteith and Dr. Ashkenazi have no relevant financial disclosures. Dr. Rapoport advises AbbVie, Biohaven, Cala Health, Dr. Reddy’s, Pfizer, Satsuma, Teva Pharmaceutical Industries, and Theranica. He is on the speakers bureau of AbbVie, Dr. Reddy’s, Impel, Pfizer and Teva Pharmaceutical Industries. Dr. Rapoport is the editor-in-chief of Neurology Reviews and on the editorial board of CNS Drugs.