User login
Prenatal betamethasone could save millions in care costs for women at risk of late preterm delivery
DALLAS – If betamethasone became a routine part of managing women at risk for late preterm birth, the U.S. health care system could save up to $200 million in direct costs every year.
A significant decrease in the cost of managing newborn respiratory morbidity would account for most of the savings, Cynthia Gyamfi-Bannerman, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine. Not only was betamethasone treatment cost effective at its base price, but treatment retained economic dominance over no treatment even when its cost was inflated up to 500%.
She presented a cost analysis of the 2016 PARENT trial. PARENT randomized 2,831 women at risk of late preterm delivery to two injections of betamethasone or matching placebo 24 hours apart. Infants exposed to betamethasone were 20% less likely to experience the primary endpoint – a composite of the need for continuous positive airway pressure or high-flow nasal cannula, supplemental oxygen, extracorporeal membrane oxygenation, or mechanical ventilation. They were also significantly less likely to be stillborn or to die within 72 hours of delivery.
“We found that antenatal betamethasone significantly decreased perinatal morbidity and mortality,” she said. “However, the costs of this intervention were unknown. Therefore, we compared the cost-effectiveness of treatment with no treatment in these women.”
Dr. Gyamfi-Bannerman described the study as a cost-minimization analysis. “The analysis took a third-party payer approach with a time horizon to first hospital discharge to home.”
Maternal costs were based on Medicaid rates. These included the cost of the betamethasone, and any out- or inpatient visits necessary to administer the drug. The neonatal costs included all direct medical costs for the newborn, including neonatal ICU admissions and any respiratory therapy the infant required.
The analysis included all mother-infant pairs in PARENT who had at least one dose of their assigned study drug and full follow-up. This comprised 1,425 pairs who received betamethasone and 1,396 who received placebo. The total mean cost of maternal/newborn care in the betamethasone group was $4,774, compared with $5,473 in the placebo group – a significant difference.
The cost-effectiveness analysis, with effectiveness defined as the proportion not reaching the primary outcome, significantly favored betamethasone as well (88.4% vs. 85.5%).
Dr. Gyamfi-Bannerman also examined cost-effectiveness in a variety of pricing scenarios, from looking at betamethasone at its base cost with hospital and physician services priced at 50% of the current level, to betamethasone inflated by 500% and other costs by 200%.
“In almost every estimate, betamethasone remained the cost-effective management option,” she said. “ and was cost effective across most of our variable estimate.”
She had no financial disclosures.
SOURCE: Gyamfi-Bannerman C et al. Am J Obstet Gynecol. 2018;218:S14.
DALLAS – If betamethasone became a routine part of managing women at risk for late preterm birth, the U.S. health care system could save up to $200 million in direct costs every year.
A significant decrease in the cost of managing newborn respiratory morbidity would account for most of the savings, Cynthia Gyamfi-Bannerman, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine. Not only was betamethasone treatment cost effective at its base price, but treatment retained economic dominance over no treatment even when its cost was inflated up to 500%.
She presented a cost analysis of the 2016 PARENT trial. PARENT randomized 2,831 women at risk of late preterm delivery to two injections of betamethasone or matching placebo 24 hours apart. Infants exposed to betamethasone were 20% less likely to experience the primary endpoint – a composite of the need for continuous positive airway pressure or high-flow nasal cannula, supplemental oxygen, extracorporeal membrane oxygenation, or mechanical ventilation. They were also significantly less likely to be stillborn or to die within 72 hours of delivery.
“We found that antenatal betamethasone significantly decreased perinatal morbidity and mortality,” she said. “However, the costs of this intervention were unknown. Therefore, we compared the cost-effectiveness of treatment with no treatment in these women.”
Dr. Gyamfi-Bannerman described the study as a cost-minimization analysis. “The analysis took a third-party payer approach with a time horizon to first hospital discharge to home.”
Maternal costs were based on Medicaid rates. These included the cost of the betamethasone, and any out- or inpatient visits necessary to administer the drug. The neonatal costs included all direct medical costs for the newborn, including neonatal ICU admissions and any respiratory therapy the infant required.
The analysis included all mother-infant pairs in PARENT who had at least one dose of their assigned study drug and full follow-up. This comprised 1,425 pairs who received betamethasone and 1,396 who received placebo. The total mean cost of maternal/newborn care in the betamethasone group was $4,774, compared with $5,473 in the placebo group – a significant difference.
The cost-effectiveness analysis, with effectiveness defined as the proportion not reaching the primary outcome, significantly favored betamethasone as well (88.4% vs. 85.5%).
Dr. Gyamfi-Bannerman also examined cost-effectiveness in a variety of pricing scenarios, from looking at betamethasone at its base cost with hospital and physician services priced at 50% of the current level, to betamethasone inflated by 500% and other costs by 200%.
“In almost every estimate, betamethasone remained the cost-effective management option,” she said. “ and was cost effective across most of our variable estimate.”
She had no financial disclosures.
SOURCE: Gyamfi-Bannerman C et al. Am J Obstet Gynecol. 2018;218:S14.
DALLAS – If betamethasone became a routine part of managing women at risk for late preterm birth, the U.S. health care system could save up to $200 million in direct costs every year.
A significant decrease in the cost of managing newborn respiratory morbidity would account for most of the savings, Cynthia Gyamfi-Bannerman, MD, said at the meeting sponsored by the Society for Maternal-Fetal Medicine. Not only was betamethasone treatment cost effective at its base price, but treatment retained economic dominance over no treatment even when its cost was inflated up to 500%.
She presented a cost analysis of the 2016 PARENT trial. PARENT randomized 2,831 women at risk of late preterm delivery to two injections of betamethasone or matching placebo 24 hours apart. Infants exposed to betamethasone were 20% less likely to experience the primary endpoint – a composite of the need for continuous positive airway pressure or high-flow nasal cannula, supplemental oxygen, extracorporeal membrane oxygenation, or mechanical ventilation. They were also significantly less likely to be stillborn or to die within 72 hours of delivery.
“We found that antenatal betamethasone significantly decreased perinatal morbidity and mortality,” she said. “However, the costs of this intervention were unknown. Therefore, we compared the cost-effectiveness of treatment with no treatment in these women.”
Dr. Gyamfi-Bannerman described the study as a cost-minimization analysis. “The analysis took a third-party payer approach with a time horizon to first hospital discharge to home.”
Maternal costs were based on Medicaid rates. These included the cost of the betamethasone, and any out- or inpatient visits necessary to administer the drug. The neonatal costs included all direct medical costs for the newborn, including neonatal ICU admissions and any respiratory therapy the infant required.
The analysis included all mother-infant pairs in PARENT who had at least one dose of their assigned study drug and full follow-up. This comprised 1,425 pairs who received betamethasone and 1,396 who received placebo. The total mean cost of maternal/newborn care in the betamethasone group was $4,774, compared with $5,473 in the placebo group – a significant difference.
The cost-effectiveness analysis, with effectiveness defined as the proportion not reaching the primary outcome, significantly favored betamethasone as well (88.4% vs. 85.5%).
Dr. Gyamfi-Bannerman also examined cost-effectiveness in a variety of pricing scenarios, from looking at betamethasone at its base cost with hospital and physician services priced at 50% of the current level, to betamethasone inflated by 500% and other costs by 200%.
“In almost every estimate, betamethasone remained the cost-effective management option,” she said. “ and was cost effective across most of our variable estimate.”
She had no financial disclosures.
SOURCE: Gyamfi-Bannerman C et al. Am J Obstet Gynecol. 2018;218:S14.
REPORTING FROM THE PREGNANCY MEETING
Key clinical point: If widely adopted, prenatal betamethasone could save up to $200 million per year by preventing neonatal respiratory morbidity.
Major finding: The total mean maternal/newborn care cost was $4,774 in the betamethasone group and $5,473 in the placebo group.
Study details: The cost analysis of the PARENT trial comprised 2,821 mother/infant pairs.
Disclosures: Dr. Gyamfi-Bannerman had no financial disclosures.
Source: Gyamfi-Bannerman C et al. Am J Obstet Gynecol. 2018;218:S14.
Advocating for reality
Our first daughter was born during my last year in medical school, and our second was born as I was finishing my second year in residency. Seeing those two little darlings grow and develop was a critical supplement to my pediatric training. And, watching my wife initially struggle and then succeed with breastfeeding provided a very personal experience and education about lactation that my interactions in the hospital and outpatient clinics didn’t offer.
We considered ourselves lucky because my wife wasn’t facing the additional challenge of returning to an out-of-the-home job. However, our good fortune did not confer immunity against the anxiety, insecurity, discomfort, and sleep deprivation–induced frustrations of breastfeeding. Watching my wife navigate the choppy waters of lactation certainly influenced my approach to counseling new mothers over my subsequent 4 decades of practice. I think I was a more sympathetic and realistic adviser based on my first-hand observations.
In a different survey of American Academy of Pediatrics fellows, more of the 832 pediatricians responding reported having had a personal experience with breastfeeding in 2014 than of the 620 responding in 1995 (68% vs. 42%). However, it is interesting that fewer of the respondents in 2014 felt that any mother can succeed at breastfeeding (predicted value = 70% in 1995, PV = 56% in 2014; P less than .05), and fewer in 2014 believed that the advantages of breastfeeding outweighed the difficulties than among those surveyed in 1995 (PV = 70% in 1995, PV = 50% in 2014; P less than .05) (Pediatrics. 2017 Oct;140[4]. pii: e20171229). These results suggest that, as more pediatricians gained personal experience with breastfeeding, more may have realized that the American Academy of Pediatrics recommendations for breastfeeding are unrealistic and may contribute to the negative experiences of some women, including pediatric trainees.
An implied assumption in the AAP News article is that a pediatrician who has had a negative breastfeeding experience is less likely to be a strong advocate for breastfeeding. I would argue that a pediatrician who has witnessed or personally experienced difficulties is more likely to be a sympathetic and realistic advocate of breastfeeding.
We must walk that fine line between actively advocating for lactation-friendly hospitals and work environments and supporting mothers who, due to circumstances beyond their control, can’t meet the expectations we have created for them.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”
Our first daughter was born during my last year in medical school, and our second was born as I was finishing my second year in residency. Seeing those two little darlings grow and develop was a critical supplement to my pediatric training. And, watching my wife initially struggle and then succeed with breastfeeding provided a very personal experience and education about lactation that my interactions in the hospital and outpatient clinics didn’t offer.
We considered ourselves lucky because my wife wasn’t facing the additional challenge of returning to an out-of-the-home job. However, our good fortune did not confer immunity against the anxiety, insecurity, discomfort, and sleep deprivation–induced frustrations of breastfeeding. Watching my wife navigate the choppy waters of lactation certainly influenced my approach to counseling new mothers over my subsequent 4 decades of practice. I think I was a more sympathetic and realistic adviser based on my first-hand observations.
In a different survey of American Academy of Pediatrics fellows, more of the 832 pediatricians responding reported having had a personal experience with breastfeeding in 2014 than of the 620 responding in 1995 (68% vs. 42%). However, it is interesting that fewer of the respondents in 2014 felt that any mother can succeed at breastfeeding (predicted value = 70% in 1995, PV = 56% in 2014; P less than .05), and fewer in 2014 believed that the advantages of breastfeeding outweighed the difficulties than among those surveyed in 1995 (PV = 70% in 1995, PV = 50% in 2014; P less than .05) (Pediatrics. 2017 Oct;140[4]. pii: e20171229). These results suggest that, as more pediatricians gained personal experience with breastfeeding, more may have realized that the American Academy of Pediatrics recommendations for breastfeeding are unrealistic and may contribute to the negative experiences of some women, including pediatric trainees.
An implied assumption in the AAP News article is that a pediatrician who has had a negative breastfeeding experience is less likely to be a strong advocate for breastfeeding. I would argue that a pediatrician who has witnessed or personally experienced difficulties is more likely to be a sympathetic and realistic advocate of breastfeeding.
We must walk that fine line between actively advocating for lactation-friendly hospitals and work environments and supporting mothers who, due to circumstances beyond their control, can’t meet the expectations we have created for them.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”
Our first daughter was born during my last year in medical school, and our second was born as I was finishing my second year in residency. Seeing those two little darlings grow and develop was a critical supplement to my pediatric training. And, watching my wife initially struggle and then succeed with breastfeeding provided a very personal experience and education about lactation that my interactions in the hospital and outpatient clinics didn’t offer.
We considered ourselves lucky because my wife wasn’t facing the additional challenge of returning to an out-of-the-home job. However, our good fortune did not confer immunity against the anxiety, insecurity, discomfort, and sleep deprivation–induced frustrations of breastfeeding. Watching my wife navigate the choppy waters of lactation certainly influenced my approach to counseling new mothers over my subsequent 4 decades of practice. I think I was a more sympathetic and realistic adviser based on my first-hand observations.
In a different survey of American Academy of Pediatrics fellows, more of the 832 pediatricians responding reported having had a personal experience with breastfeeding in 2014 than of the 620 responding in 1995 (68% vs. 42%). However, it is interesting that fewer of the respondents in 2014 felt that any mother can succeed at breastfeeding (predicted value = 70% in 1995, PV = 56% in 2014; P less than .05), and fewer in 2014 believed that the advantages of breastfeeding outweighed the difficulties than among those surveyed in 1995 (PV = 70% in 1995, PV = 50% in 2014; P less than .05) (Pediatrics. 2017 Oct;140[4]. pii: e20171229). These results suggest that, as more pediatricians gained personal experience with breastfeeding, more may have realized that the American Academy of Pediatrics recommendations for breastfeeding are unrealistic and may contribute to the negative experiences of some women, including pediatric trainees.
An implied assumption in the AAP News article is that a pediatrician who has had a negative breastfeeding experience is less likely to be a strong advocate for breastfeeding. I would argue that a pediatrician who has witnessed or personally experienced difficulties is more likely to be a sympathetic and realistic advocate of breastfeeding.
We must walk that fine line between actively advocating for lactation-friendly hospitals and work environments and supporting mothers who, due to circumstances beyond their control, can’t meet the expectations we have created for them.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”
… What comes naturally
When we were invited to a family gathering to celebrate a 60th birthday, we expected to hear an abundance of news about grandchildren. They are natural, and seldom controversial, topics of discussion. If there is a child still waiting in utero and destined to be the first grandchild on one or both sides of the family, the impending adventure in parenthood will dominate the conversation.
To our great surprise, despite the presence of one very pregnant young woman, who in 6 weeks would be giving birth to the first grandchild in my nephew’s family, my wife and I can recall only one brief dialogue in which I was asked about how one might go about selecting a pediatrician.
I’m not sure why the blessed event to come was being ignored, but I found the oversight unusual and refreshing. It is possible that there had been so much hype about the pregnancy on her side of the family that the couple relished its absence from the birthday party’s topics for discussion.
In the spirit of full disclosure, I must add that, as a result of my frequent claims of ignorance when asked about medically related topics, I am often referred to by the extended family as “Dr. I-Don’t-Know.” It may be that my presence influenced the conversation, but regardless of the reason, I was impressed with the ease at which this couple was approaching the birth of their first child.
I am sure they harbor some anxieties, and I am sure they have listened to some horror stories from their peers about sleep and breastfeeding problems. They are bright people who acknowledge that they are going to encounter some bumps along the road of parenthood. However, they seem to be immune to the epidemic of anxiety that for decades has been sweeping over cohorts of North Americans entering their family-building years.
The young couple my wife and I encountered are just as clueless about what parenthood has in store as their anxiety-driven peers are. The difference is that they are enjoying their pregnancy in blissful ignorance buffered by their refreshing confidence that, however they do it, they will be doing it naturally.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”
When we were invited to a family gathering to celebrate a 60th birthday, we expected to hear an abundance of news about grandchildren. They are natural, and seldom controversial, topics of discussion. If there is a child still waiting in utero and destined to be the first grandchild on one or both sides of the family, the impending adventure in parenthood will dominate the conversation.
To our great surprise, despite the presence of one very pregnant young woman, who in 6 weeks would be giving birth to the first grandchild in my nephew’s family, my wife and I can recall only one brief dialogue in which I was asked about how one might go about selecting a pediatrician.
I’m not sure why the blessed event to come was being ignored, but I found the oversight unusual and refreshing. It is possible that there had been so much hype about the pregnancy on her side of the family that the couple relished its absence from the birthday party’s topics for discussion.
In the spirit of full disclosure, I must add that, as a result of my frequent claims of ignorance when asked about medically related topics, I am often referred to by the extended family as “Dr. I-Don’t-Know.” It may be that my presence influenced the conversation, but regardless of the reason, I was impressed with the ease at which this couple was approaching the birth of their first child.
I am sure they harbor some anxieties, and I am sure they have listened to some horror stories from their peers about sleep and breastfeeding problems. They are bright people who acknowledge that they are going to encounter some bumps along the road of parenthood. However, they seem to be immune to the epidemic of anxiety that for decades has been sweeping over cohorts of North Americans entering their family-building years.
The young couple my wife and I encountered are just as clueless about what parenthood has in store as their anxiety-driven peers are. The difference is that they are enjoying their pregnancy in blissful ignorance buffered by their refreshing confidence that, however they do it, they will be doing it naturally.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”
When we were invited to a family gathering to celebrate a 60th birthday, we expected to hear an abundance of news about grandchildren. They are natural, and seldom controversial, topics of discussion. If there is a child still waiting in utero and destined to be the first grandchild on one or both sides of the family, the impending adventure in parenthood will dominate the conversation.
To our great surprise, despite the presence of one very pregnant young woman, who in 6 weeks would be giving birth to the first grandchild in my nephew’s family, my wife and I can recall only one brief dialogue in which I was asked about how one might go about selecting a pediatrician.
I’m not sure why the blessed event to come was being ignored, but I found the oversight unusual and refreshing. It is possible that there had been so much hype about the pregnancy on her side of the family that the couple relished its absence from the birthday party’s topics for discussion.
In the spirit of full disclosure, I must add that, as a result of my frequent claims of ignorance when asked about medically related topics, I am often referred to by the extended family as “Dr. I-Don’t-Know.” It may be that my presence influenced the conversation, but regardless of the reason, I was impressed with the ease at which this couple was approaching the birth of their first child.
I am sure they harbor some anxieties, and I am sure they have listened to some horror stories from their peers about sleep and breastfeeding problems. They are bright people who acknowledge that they are going to encounter some bumps along the road of parenthood. However, they seem to be immune to the epidemic of anxiety that for decades has been sweeping over cohorts of North Americans entering their family-building years.
The young couple my wife and I encountered are just as clueless about what parenthood has in store as their anxiety-driven peers are. The difference is that they are enjoying their pregnancy in blissful ignorance buffered by their refreshing confidence that, however they do it, they will be doing it naturally.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.”
Is elective induction at 39 weeks a good idea?
DALLAS – Elective inductions at 39 weeks’ gestation were safe for the newborn and conferred dual benefits upon first-time mothers, reducing the risk of cesarean delivery by 16% and pregnancy-related hypertensive disorder by 36%, compared with women managed expectantly.
Infants delivered by elective inductions were smaller than those born to expectantly managed women and experienced a 29% reduction in the need for respiratory support at birth, William A. Grobman, MD, reported at the meeting, sponsored by the Society for Maternal-Fetal Medicine. They were no more likely than infants in the comparator group to experience dangerous perinatal outcomes, including low Apgar scores, meconium inhalation, hypoxia, or birth trauma, said Dr. Grobman, professor of obstetrics and gynecology at Northwestern University, Chicago.
The new data, however, may set a new standard by which to make this decision, Dr. Grobman said.
“I will leave it up to the professional organizations to determine the final outcome of these data, but it’s important to understand that the Choosing Wisely recommendation was based on observational data that essentially used an incorrect clinical comparator” of spontaneous labor, he said. The large study that Dr. Grobman and his colleagues conducted used expectant management (EM) as the comparator, allowing women to continue up to 42 weeks’ gestation. Using this comparator, he said, “Our data are largely with almost every observational study” and with a recently published randomized controlled trial by Kate F. Walker, a clinical research fellow at the University of Nottingham (England).
That study determined that labor induction between 39 weeks and 39 weeks, 6 days, in women older than 35 years had no significant effect on the rate of cesarean section and no adverse short-term effects on maternal or neonatal outcomes.
Dr. Grobman conducted his randomized trial at 41 hospitals in the National Institutes of Health’s Maternal-Fetal Medicine Units Network.
It randomized 6,106 healthy, nulliparous women to either elective induction from 39 weeks to 39 weeks, 4 days, or to EM. These women were asked to forgo elective delivery before 40 weeks, 5 days, but to be delivered by 42 weeks, 2 days.
The primary perinatal outcome was a composite endpoint that included fetal or neonatal death; respiratory support in the first 72 hours; 5-minute Apgar of 3 or lower; hypoxic ischemic encephalopathy; seizure; infection; meconium aspiration syndrome; birth trauma; intracranial or subgaleal hemorrhage; and hypotension requiring vasopressors.
The primary maternal outcome was a composite of cesarean delivery; hypertensive disorder of pregnancy; postpartum hemorrhage; chorioamnionitis; postpartum infection; labor pain; and the Labour Agentry Scale, a midwife-created measure of a laboring woman’s perception of her birth experience.
Women were a mean of 23.5 years old; about 44% of each group was privately insured. Prior pregnancy loss was more common among those randomized to EM (25.6% vs. 22.8%). Just over half were obese, with a body mass index of at least 30 kg/m2. Most (about 63%) had an unfavorable cervix, with a Bishop score of less than 5. The trial specified no particular induction regimen, Dr. Grobman said. “There were a variety of ripening agents and oxytocin regimens used.”
Infants in the elective induction group were born significantly earlier than were those in the EM group (39.3 vs. 40 weeks) and weighed significantly less (3,300 g vs. 3,380 g). Induction was safe for the newborn, with the primary endpoint occurring in 4.4%, compared with 5.4% of those in the EM group – not significantly different.
When investigators examined each outcome in the perinatal composite individually, only one – early respiratory support – was significantly different from the EM group. Infants in the induction group were 29% less likely to need respiratory support in the first 72 hours (3% vs. 4.2%; relative risk, 0.71). The rate of cesarean delivery also was significantly less among the induction group (18.6% vs. 22.2%; RR, 0.84).
None of these outcomes changed when the investigators controlled for race/ethnicity, Bishop score of less than 5, body mass index of 30 kg/m2 or more, or advanced maternal age.
Induction also was safe for mothers, and conferred a significant 36% reduction in the risk of pregnancy-related hypertensive disorders (9.1% vs. 14.1%; RR, 0.64). All other maternal outcomes were similar between the two groups.
The Agentry scale results also showed that women who were induced felt they were more in control of their birth experience, both at delivery and at 6 weeks’ postpartum. They also rated their worst labor pain and overall labor pain as significantly less than did women in the EM group.
“Our result suggest that policies directed toward avoidance of elective labor induction in nulliparous women would be unlikely to reduce the rate of cesarean section on a population level,” Dr. Grobman said. “To the contrary, our data show that, for every 28 nulliparous women to undergo elective induction at 39 weeks, one cesarean section would be avoided. Additionally, the number needed to treat to prevent one case of neonatal respiratory support is 83, and to prevent one case of hypertensive disease of pregnancy, 20. Our results should provide information useful to women as they consider their options, and can be incorporated into shared decision-making discussions with the provider.”
The study was sponsored by the National Institutes of Health. Dr. Grobman had no financial disclosures.
SOURCE: Grobman W. Am J Obstet Gynecol. 2018 Jan;218:S601.
DALLAS – Elective inductions at 39 weeks’ gestation were safe for the newborn and conferred dual benefits upon first-time mothers, reducing the risk of cesarean delivery by 16% and pregnancy-related hypertensive disorder by 36%, compared with women managed expectantly.
Infants delivered by elective inductions were smaller than those born to expectantly managed women and experienced a 29% reduction in the need for respiratory support at birth, William A. Grobman, MD, reported at the meeting, sponsored by the Society for Maternal-Fetal Medicine. They were no more likely than infants in the comparator group to experience dangerous perinatal outcomes, including low Apgar scores, meconium inhalation, hypoxia, or birth trauma, said Dr. Grobman, professor of obstetrics and gynecology at Northwestern University, Chicago.
The new data, however, may set a new standard by which to make this decision, Dr. Grobman said.
“I will leave it up to the professional organizations to determine the final outcome of these data, but it’s important to understand that the Choosing Wisely recommendation was based on observational data that essentially used an incorrect clinical comparator” of spontaneous labor, he said. The large study that Dr. Grobman and his colleagues conducted used expectant management (EM) as the comparator, allowing women to continue up to 42 weeks’ gestation. Using this comparator, he said, “Our data are largely with almost every observational study” and with a recently published randomized controlled trial by Kate F. Walker, a clinical research fellow at the University of Nottingham (England).
That study determined that labor induction between 39 weeks and 39 weeks, 6 days, in women older than 35 years had no significant effect on the rate of cesarean section and no adverse short-term effects on maternal or neonatal outcomes.
Dr. Grobman conducted his randomized trial at 41 hospitals in the National Institutes of Health’s Maternal-Fetal Medicine Units Network.
It randomized 6,106 healthy, nulliparous women to either elective induction from 39 weeks to 39 weeks, 4 days, or to EM. These women were asked to forgo elective delivery before 40 weeks, 5 days, but to be delivered by 42 weeks, 2 days.
The primary perinatal outcome was a composite endpoint that included fetal or neonatal death; respiratory support in the first 72 hours; 5-minute Apgar of 3 or lower; hypoxic ischemic encephalopathy; seizure; infection; meconium aspiration syndrome; birth trauma; intracranial or subgaleal hemorrhage; and hypotension requiring vasopressors.
The primary maternal outcome was a composite of cesarean delivery; hypertensive disorder of pregnancy; postpartum hemorrhage; chorioamnionitis; postpartum infection; labor pain; and the Labour Agentry Scale, a midwife-created measure of a laboring woman’s perception of her birth experience.
Women were a mean of 23.5 years old; about 44% of each group was privately insured. Prior pregnancy loss was more common among those randomized to EM (25.6% vs. 22.8%). Just over half were obese, with a body mass index of at least 30 kg/m2. Most (about 63%) had an unfavorable cervix, with a Bishop score of less than 5. The trial specified no particular induction regimen, Dr. Grobman said. “There were a variety of ripening agents and oxytocin regimens used.”
Infants in the elective induction group were born significantly earlier than were those in the EM group (39.3 vs. 40 weeks) and weighed significantly less (3,300 g vs. 3,380 g). Induction was safe for the newborn, with the primary endpoint occurring in 4.4%, compared with 5.4% of those in the EM group – not significantly different.
When investigators examined each outcome in the perinatal composite individually, only one – early respiratory support – was significantly different from the EM group. Infants in the induction group were 29% less likely to need respiratory support in the first 72 hours (3% vs. 4.2%; relative risk, 0.71). The rate of cesarean delivery also was significantly less among the induction group (18.6% vs. 22.2%; RR, 0.84).
None of these outcomes changed when the investigators controlled for race/ethnicity, Bishop score of less than 5, body mass index of 30 kg/m2 or more, or advanced maternal age.
Induction also was safe for mothers, and conferred a significant 36% reduction in the risk of pregnancy-related hypertensive disorders (9.1% vs. 14.1%; RR, 0.64). All other maternal outcomes were similar between the two groups.
The Agentry scale results also showed that women who were induced felt they were more in control of their birth experience, both at delivery and at 6 weeks’ postpartum. They also rated their worst labor pain and overall labor pain as significantly less than did women in the EM group.
“Our result suggest that policies directed toward avoidance of elective labor induction in nulliparous women would be unlikely to reduce the rate of cesarean section on a population level,” Dr. Grobman said. “To the contrary, our data show that, for every 28 nulliparous women to undergo elective induction at 39 weeks, one cesarean section would be avoided. Additionally, the number needed to treat to prevent one case of neonatal respiratory support is 83, and to prevent one case of hypertensive disease of pregnancy, 20. Our results should provide information useful to women as they consider their options, and can be incorporated into shared decision-making discussions with the provider.”
The study was sponsored by the National Institutes of Health. Dr. Grobman had no financial disclosures.
SOURCE: Grobman W. Am J Obstet Gynecol. 2018 Jan;218:S601.
DALLAS – Elective inductions at 39 weeks’ gestation were safe for the newborn and conferred dual benefits upon first-time mothers, reducing the risk of cesarean delivery by 16% and pregnancy-related hypertensive disorder by 36%, compared with women managed expectantly.
Infants delivered by elective inductions were smaller than those born to expectantly managed women and experienced a 29% reduction in the need for respiratory support at birth, William A. Grobman, MD, reported at the meeting, sponsored by the Society for Maternal-Fetal Medicine. They were no more likely than infants in the comparator group to experience dangerous perinatal outcomes, including low Apgar scores, meconium inhalation, hypoxia, or birth trauma, said Dr. Grobman, professor of obstetrics and gynecology at Northwestern University, Chicago.
The new data, however, may set a new standard by which to make this decision, Dr. Grobman said.
“I will leave it up to the professional organizations to determine the final outcome of these data, but it’s important to understand that the Choosing Wisely recommendation was based on observational data that essentially used an incorrect clinical comparator” of spontaneous labor, he said. The large study that Dr. Grobman and his colleagues conducted used expectant management (EM) as the comparator, allowing women to continue up to 42 weeks’ gestation. Using this comparator, he said, “Our data are largely with almost every observational study” and with a recently published randomized controlled trial by Kate F. Walker, a clinical research fellow at the University of Nottingham (England).
That study determined that labor induction between 39 weeks and 39 weeks, 6 days, in women older than 35 years had no significant effect on the rate of cesarean section and no adverse short-term effects on maternal or neonatal outcomes.
Dr. Grobman conducted his randomized trial at 41 hospitals in the National Institutes of Health’s Maternal-Fetal Medicine Units Network.
It randomized 6,106 healthy, nulliparous women to either elective induction from 39 weeks to 39 weeks, 4 days, or to EM. These women were asked to forgo elective delivery before 40 weeks, 5 days, but to be delivered by 42 weeks, 2 days.
The primary perinatal outcome was a composite endpoint that included fetal or neonatal death; respiratory support in the first 72 hours; 5-minute Apgar of 3 or lower; hypoxic ischemic encephalopathy; seizure; infection; meconium aspiration syndrome; birth trauma; intracranial or subgaleal hemorrhage; and hypotension requiring vasopressors.
The primary maternal outcome was a composite of cesarean delivery; hypertensive disorder of pregnancy; postpartum hemorrhage; chorioamnionitis; postpartum infection; labor pain; and the Labour Agentry Scale, a midwife-created measure of a laboring woman’s perception of her birth experience.
Women were a mean of 23.5 years old; about 44% of each group was privately insured. Prior pregnancy loss was more common among those randomized to EM (25.6% vs. 22.8%). Just over half were obese, with a body mass index of at least 30 kg/m2. Most (about 63%) had an unfavorable cervix, with a Bishop score of less than 5. The trial specified no particular induction regimen, Dr. Grobman said. “There were a variety of ripening agents and oxytocin regimens used.”
Infants in the elective induction group were born significantly earlier than were those in the EM group (39.3 vs. 40 weeks) and weighed significantly less (3,300 g vs. 3,380 g). Induction was safe for the newborn, with the primary endpoint occurring in 4.4%, compared with 5.4% of those in the EM group – not significantly different.
When investigators examined each outcome in the perinatal composite individually, only one – early respiratory support – was significantly different from the EM group. Infants in the induction group were 29% less likely to need respiratory support in the first 72 hours (3% vs. 4.2%; relative risk, 0.71). The rate of cesarean delivery also was significantly less among the induction group (18.6% vs. 22.2%; RR, 0.84).
None of these outcomes changed when the investigators controlled for race/ethnicity, Bishop score of less than 5, body mass index of 30 kg/m2 or more, or advanced maternal age.
Induction also was safe for mothers, and conferred a significant 36% reduction in the risk of pregnancy-related hypertensive disorders (9.1% vs. 14.1%; RR, 0.64). All other maternal outcomes were similar between the two groups.
The Agentry scale results also showed that women who were induced felt they were more in control of their birth experience, both at delivery and at 6 weeks’ postpartum. They also rated their worst labor pain and overall labor pain as significantly less than did women in the EM group.
“Our result suggest that policies directed toward avoidance of elective labor induction in nulliparous women would be unlikely to reduce the rate of cesarean section on a population level,” Dr. Grobman said. “To the contrary, our data show that, for every 28 nulliparous women to undergo elective induction at 39 weeks, one cesarean section would be avoided. Additionally, the number needed to treat to prevent one case of neonatal respiratory support is 83, and to prevent one case of hypertensive disease of pregnancy, 20. Our results should provide information useful to women as they consider their options, and can be incorporated into shared decision-making discussions with the provider.”
The study was sponsored by the National Institutes of Health. Dr. Grobman had no financial disclosures.
SOURCE: Grobman W. Am J Obstet Gynecol. 2018 Jan;218:S601.
AT THE PREGNANCY MEETING
Key clinical point: Induction at 39 weeks conferred some health benefits to nulliparous women and didn’t harm infants.
Major finding: Induction reduced risk of C-section by 16% and risk of pregnancy-related hypertensive disorder by 36%, compared with expectant management.
Study details: The study randomized 6,106 women to elective induction or expectant management with delivery by 42 weeks.
Disclosures: The National Institutes of Health sponsored the study; Dr. Grobman had no financial disclosures.
Source: Grobman W. Am J Obstet Gynecol. 2018 Jan;218:S601.
Adacel Tdap effective throughout third trimester vaccination window
, according to a prospective cohort study published in Obstetrics and Gynecology.
Timing does make a difference with the other Tdap option in pregnancy, Boostrix; pertussis protection is stronger if women receive it early in the third trimester. The investigators wanted to see if that were true as well with Adacel.
They compared pertussis antibody concentrations in maternal venous serum and umbilical cord arterial serum at the time of delivery in 52 women vaccinated from 27 to 30 6/7 weeks of gestation, and compared the results with 36 women vaccinated from 31 to 35 6/7 weeks.
Pertussis antibody concentrations did not vary by gestational age. Maternal serum pertussis toxin IgG concentrations were the same in both groups (48.6 enzyme-linked immunoassay [ELISA] units/mL), and there were no statistically significant differences in cord serum pertussis toxin IgG concentrations (92.1 ELISA units/mL in the early group, compared with 90.7 in the later group; P = .95) or cord serum pertactin IgG concentrations (798 international units/mL in the early group, versus 730 in the later group; P = .73).
Overall, cord serum pertussis toxin IgG concentrations were approximately twice maternal serum pertussis toxin IgG concentrations (91.6 vs. 48.6 ELISA units/mL; P less than .01). Cord serum pertussis toxin IgG concentrations were in the protective range (greater than 10 ELISA units/mL) in 87% of the women vaccinated from 27 to 30 6/7 weeks, and in 97% vaccinated from 31 to 35 6/7 weeks (P = .13).
Maternal vaccination in the third trimester against pertussis “was associated with a high percentage of newborns with antibody concentrations conferring protection,” said investigators led by Cynthia Abraham, MD, an ob.gyn. at Mount Sinai Hospital, New York. “We found no significant difference across the period of 27-36 weeks of gestation with respect to immunogenicity with Adacel use.”
Maternal Tdap vaccination is done to protect infants in their first 2 months of life, before they start their DTaP series. The Centers for Disease Control and Prevention recommends vaccination between 27 and 36 weeks of gestation.
It’s unclear why it doesn’t matter when within that window women receive Adacel, but protection with Boostrix if Boostrix is administered early on in the trimester.
Boostrix differs from Adacel in antigen composition and in the method of pertussis toxin detoxification. Boostrix is detoxified with formaldehyde and glutaraldehyde. Adacel is detoxified only with formaldehyde.
“Double detoxification may cause differences in immunogenicity as antigenic epitopes are further modified, perhaps providing an explanation for the difference in results between the vaccines,” the investigators said.
Women in the early group received Adacel at a mean gestational age of 29.1 weeks, versus 32.9 weeks in the later group. The women were a mean age of about 29 years; 56% were Hispanic, 23% white, and the rest were about equally split between black and Asian women.
No funding source was reported. The authors did not have any conflicts of interest.
SOURCE: Abraham C et al. Obstet Gynecol. 2018 Feb;131(2):364-9.
, according to a prospective cohort study published in Obstetrics and Gynecology.
Timing does make a difference with the other Tdap option in pregnancy, Boostrix; pertussis protection is stronger if women receive it early in the third trimester. The investigators wanted to see if that were true as well with Adacel.
They compared pertussis antibody concentrations in maternal venous serum and umbilical cord arterial serum at the time of delivery in 52 women vaccinated from 27 to 30 6/7 weeks of gestation, and compared the results with 36 women vaccinated from 31 to 35 6/7 weeks.
Pertussis antibody concentrations did not vary by gestational age. Maternal serum pertussis toxin IgG concentrations were the same in both groups (48.6 enzyme-linked immunoassay [ELISA] units/mL), and there were no statistically significant differences in cord serum pertussis toxin IgG concentrations (92.1 ELISA units/mL in the early group, compared with 90.7 in the later group; P = .95) or cord serum pertactin IgG concentrations (798 international units/mL in the early group, versus 730 in the later group; P = .73).
Overall, cord serum pertussis toxin IgG concentrations were approximately twice maternal serum pertussis toxin IgG concentrations (91.6 vs. 48.6 ELISA units/mL; P less than .01). Cord serum pertussis toxin IgG concentrations were in the protective range (greater than 10 ELISA units/mL) in 87% of the women vaccinated from 27 to 30 6/7 weeks, and in 97% vaccinated from 31 to 35 6/7 weeks (P = .13).
Maternal vaccination in the third trimester against pertussis “was associated with a high percentage of newborns with antibody concentrations conferring protection,” said investigators led by Cynthia Abraham, MD, an ob.gyn. at Mount Sinai Hospital, New York. “We found no significant difference across the period of 27-36 weeks of gestation with respect to immunogenicity with Adacel use.”
Maternal Tdap vaccination is done to protect infants in their first 2 months of life, before they start their DTaP series. The Centers for Disease Control and Prevention recommends vaccination between 27 and 36 weeks of gestation.
It’s unclear why it doesn’t matter when within that window women receive Adacel, but protection with Boostrix if Boostrix is administered early on in the trimester.
Boostrix differs from Adacel in antigen composition and in the method of pertussis toxin detoxification. Boostrix is detoxified with formaldehyde and glutaraldehyde. Adacel is detoxified only with formaldehyde.
“Double detoxification may cause differences in immunogenicity as antigenic epitopes are further modified, perhaps providing an explanation for the difference in results between the vaccines,” the investigators said.
Women in the early group received Adacel at a mean gestational age of 29.1 weeks, versus 32.9 weeks in the later group. The women were a mean age of about 29 years; 56% were Hispanic, 23% white, and the rest were about equally split between black and Asian women.
No funding source was reported. The authors did not have any conflicts of interest.
SOURCE: Abraham C et al. Obstet Gynecol. 2018 Feb;131(2):364-9.
, according to a prospective cohort study published in Obstetrics and Gynecology.
Timing does make a difference with the other Tdap option in pregnancy, Boostrix; pertussis protection is stronger if women receive it early in the third trimester. The investigators wanted to see if that were true as well with Adacel.
They compared pertussis antibody concentrations in maternal venous serum and umbilical cord arterial serum at the time of delivery in 52 women vaccinated from 27 to 30 6/7 weeks of gestation, and compared the results with 36 women vaccinated from 31 to 35 6/7 weeks.
Pertussis antibody concentrations did not vary by gestational age. Maternal serum pertussis toxin IgG concentrations were the same in both groups (48.6 enzyme-linked immunoassay [ELISA] units/mL), and there were no statistically significant differences in cord serum pertussis toxin IgG concentrations (92.1 ELISA units/mL in the early group, compared with 90.7 in the later group; P = .95) or cord serum pertactin IgG concentrations (798 international units/mL in the early group, versus 730 in the later group; P = .73).
Overall, cord serum pertussis toxin IgG concentrations were approximately twice maternal serum pertussis toxin IgG concentrations (91.6 vs. 48.6 ELISA units/mL; P less than .01). Cord serum pertussis toxin IgG concentrations were in the protective range (greater than 10 ELISA units/mL) in 87% of the women vaccinated from 27 to 30 6/7 weeks, and in 97% vaccinated from 31 to 35 6/7 weeks (P = .13).
Maternal vaccination in the third trimester against pertussis “was associated with a high percentage of newborns with antibody concentrations conferring protection,” said investigators led by Cynthia Abraham, MD, an ob.gyn. at Mount Sinai Hospital, New York. “We found no significant difference across the period of 27-36 weeks of gestation with respect to immunogenicity with Adacel use.”
Maternal Tdap vaccination is done to protect infants in their first 2 months of life, before they start their DTaP series. The Centers for Disease Control and Prevention recommends vaccination between 27 and 36 weeks of gestation.
It’s unclear why it doesn’t matter when within that window women receive Adacel, but protection with Boostrix if Boostrix is administered early on in the trimester.
Boostrix differs from Adacel in antigen composition and in the method of pertussis toxin detoxification. Boostrix is detoxified with formaldehyde and glutaraldehyde. Adacel is detoxified only with formaldehyde.
“Double detoxification may cause differences in immunogenicity as antigenic epitopes are further modified, perhaps providing an explanation for the difference in results between the vaccines,” the investigators said.
Women in the early group received Adacel at a mean gestational age of 29.1 weeks, versus 32.9 weeks in the later group. The women were a mean age of about 29 years; 56% were Hispanic, 23% white, and the rest were about equally split between black and Asian women.
No funding source was reported. The authors did not have any conflicts of interest.
SOURCE: Abraham C et al. Obstet Gynecol. 2018 Feb;131(2):364-9.
FROM OBSTETRICS AND GYNECOLOGY
Key clinical point: Unlike Boostrix, pertussis protection is the same whether pregnant women receive Adacel Tdap vaccine early in the third trimester or in the middle.
Major finding: There were no statistically significant differences in cord serum pertussis toxin IgG concentrations (92.1 ELISA units/mL in the early group, versus 90.7 in the later group, P = .95).
Study details: A prospective cohort study involving 88 women.
Disclosures: No study sponsor was reported. The authors had no disclosures.
Source: Abraham C et al. Obstet Gynecol. 2018 Feb;131(2):364-9.
Nutrition early in life has long-term effects on neurodevelopment
Nutrition within the first 1,000 days of childhood are pivotal in a child’s neurodevelopment and lifelong health, according to an American Academy of Pediatrics policy statement.
“Healthy, normal neurodevelopment is a complex process involving cellular and structural changes in the brain that proceed in a specified sequence,” wrote Sara Jane Schwarzenberg, MD and Michael K. Georgieff, MD, both of the University of Minnesota Masonic Children’s Hospital, Minneapolis, and the AAP Committee on Nutrition. “Changes that are too rapid or too slow in one part of the brain may result in the failure of crucial pathway connections to other parts of the brain. Timing is crucial; once a particular developmental sequence fails, it may not be possible to retrieve all the lost function,” the investigators and committee noted in a report published in Pediatrics (Pediatrics. 2018; 141[2]:e20173716).
The importance of macronutrients was highlighted in a study of rural Guatemalan children during 1969-1989 who received high-calorie or low-calorie protein supplements. Children who received the high-calorie/high protein supplements before age 2 years had higher test scores, better reading and vocabulary skills, and faster information processing abilities, compared with their low-calorie/low-protein counterparts.
Like the low-calorie/low-protein Guatemalans, there are many populations that lack access to high-quality macronutrient sources or have access to only low-quality macronutrients. In the United States in 2015, 16.6% of households (6.4 million) were food insecure. This was even more pronounced in households with incomes below the poverty line, with 36.8% being food insecure, according to studies from the Department of Agriculture.
Food insecurity is not limited to macronutrients but extends to micronutrients such as vitamins and minerals like zinc; iron; choline; folate; iodine; vitamins A, D, B6, and B12; and long-chain polyunsaturated fatty acids. A lack of any of these micronutrients in early childhood can lead to neurodevelopmental issues later in life, Dr. Schwarzenberg, Dr. Georgieff, and the committee emphasized. An important source of micronutrients is human milk, provided by breastfeeding. Studies have shown that breastfeeding of preterm and term infants improves cognitive performance, compared with infants who consume formula (J Pediatr. 2016;177:133-9.e1; Curr Opin Pediatr. 2016;28[4]:559-66).
Because proper consumption of macronutrients and micronutrients is so important, a number of government-sponsored programs exist that provide nutritional support to women, infants, and young children. The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) is one of the most important programs, helping 53% of children under the age of 1 year. The Supplemental Nutrition Assistance Program (SNAP) also supplies economic aid to buy nutritious foods; it kept approximately 4.9 million children out of poverty in 2012, the researchers said. SNAP Nutrition Education, a partnership between SNAP and the Department of Agriculture, gives SNAP participants and eligible nonparticipants skills and information to help them to make healthy food choices with limited money.
The article highlights some important information, but is not an exhaustive discussion of the AAP policy statement. To make the information from the policy statement more applicable, Dr. Schwarzenberg, Dr. Georgieff, and the committee provided 10 takeaway recommendations for pediatricians.
1. Be knowledgeable about breastfeeding and help breastfeeding mothers. The AAP recommends exclusive breastfeeding for the first 6 months of a child’s life and to continue breastfeeding with the addition of food for at least the first year of life, and even after that if the mother and child so desire.
2. Advocate at the local, state, and federal levels to preserve and strengthen nutritional and assistance programs focusing on prenatal and neonatal nutrition. This can help support proper neurodevelopment and minimize negative environmental factors.
3. Openly discuss proper nutritions effects on infant neurodevelopment with parents. Know which nutrients are at risk in the breastfed infant after 6 months, such as zinc, iron, and vitamin D. A good resource is “Pediatric Nutrition, 7th edition” (Itasca, Ill. American Academy of Pediatrics, 2014).
4. Convey that eating healthy is a positive choice, not just an avoidance of unhealthy foods.
5. Inform food pantries and soup kitchens that the food packages and meals they provide should have higher levels of macronutrients and micronutrients.
6. Encourage parents to make use of programs like WIC and SNAP, and advocate for removing barriers that parents face in enrolling or reenrolling in such programs.
7. Oppose changes in eligibility to assistance programs that would adversely affect children.
8. Anticipate neurodevelopmental issues with children and address the issue early. For example, educate yourself about which nutrients are at risk for deficiency and at what ages.
9. Work with obstetricians to encourage improvements in maternal diet, which will affect the micronutrients available for the developing fetus.
10. Become advocates in the “Hunger Community,” working to reduce hunger at the local level across the United States. A chart in the article lists organizations focused on hunger, such as Feeding America, 1,000 Days, Share Our Strength, and others.
There was no external funding for this research, and the authors had no relevant financial disclosures or potential conflicts of interest to report.
While you might not typically put chopped or blended, unsalted, boiled canned oysters on your usual list of recommended infant and toddler foods, maybe you should.
The AAP just published a new policy statement on advocacy to improve child nutrition in the first 1,000 days (from conception to age 2 years). The statement emphasizes the importance of nutrition to optimal brain development. Pediatricians are encouraged to be familiar with community services to support optimal nutrition such as the Special Supplemental Nutrition Program for Women, Infants, and Children, the Supplemental Nutrition Assistance Program, the Child and Adult Care Food Program, and food pantries and soup kitchens, but also to get beyond recommending a “good diet” to something more specific which is high in key nutrients important for brain development such as protein; zinc; iron; choline; folate; iodine; vitamins A, D, B6, and B12; and polyunsaturated fatty acids. That’s where the boiled oysters, a decent source of the listed nutrients and especially loaded with zinc, iron, and vitamin B12, come in. While not everyone is going to rush out to buy their baby such an unexpected (and for many, unfamiliar) food, the statement reminds pediatricians to recommend foods that are good sources of the nutrients that babies and toddlers need most. Other foods that fit the bill include oatmeal, meat and poultry, fish like salmon and tuna, eggs, tofu and soybeans, and other legumes and beans like chickpeas and lentils.
Natalie D. Muth, MD, is a pediatrician at Children’s Primary Care Medical Group in Carlsbad, Calif. She has no relevant financial disclosures.
While you might not typically put chopped or blended, unsalted, boiled canned oysters on your usual list of recommended infant and toddler foods, maybe you should.
The AAP just published a new policy statement on advocacy to improve child nutrition in the first 1,000 days (from conception to age 2 years). The statement emphasizes the importance of nutrition to optimal brain development. Pediatricians are encouraged to be familiar with community services to support optimal nutrition such as the Special Supplemental Nutrition Program for Women, Infants, and Children, the Supplemental Nutrition Assistance Program, the Child and Adult Care Food Program, and food pantries and soup kitchens, but also to get beyond recommending a “good diet” to something more specific which is high in key nutrients important for brain development such as protein; zinc; iron; choline; folate; iodine; vitamins A, D, B6, and B12; and polyunsaturated fatty acids. That’s where the boiled oysters, a decent source of the listed nutrients and especially loaded with zinc, iron, and vitamin B12, come in. While not everyone is going to rush out to buy their baby such an unexpected (and for many, unfamiliar) food, the statement reminds pediatricians to recommend foods that are good sources of the nutrients that babies and toddlers need most. Other foods that fit the bill include oatmeal, meat and poultry, fish like salmon and tuna, eggs, tofu and soybeans, and other legumes and beans like chickpeas and lentils.
Natalie D. Muth, MD, is a pediatrician at Children’s Primary Care Medical Group in Carlsbad, Calif. She has no relevant financial disclosures.
While you might not typically put chopped or blended, unsalted, boiled canned oysters on your usual list of recommended infant and toddler foods, maybe you should.
The AAP just published a new policy statement on advocacy to improve child nutrition in the first 1,000 days (from conception to age 2 years). The statement emphasizes the importance of nutrition to optimal brain development. Pediatricians are encouraged to be familiar with community services to support optimal nutrition such as the Special Supplemental Nutrition Program for Women, Infants, and Children, the Supplemental Nutrition Assistance Program, the Child and Adult Care Food Program, and food pantries and soup kitchens, but also to get beyond recommending a “good diet” to something more specific which is high in key nutrients important for brain development such as protein; zinc; iron; choline; folate; iodine; vitamins A, D, B6, and B12; and polyunsaturated fatty acids. That’s where the boiled oysters, a decent source of the listed nutrients and especially loaded with zinc, iron, and vitamin B12, come in. While not everyone is going to rush out to buy their baby such an unexpected (and for many, unfamiliar) food, the statement reminds pediatricians to recommend foods that are good sources of the nutrients that babies and toddlers need most. Other foods that fit the bill include oatmeal, meat and poultry, fish like salmon and tuna, eggs, tofu and soybeans, and other legumes and beans like chickpeas and lentils.
Natalie D. Muth, MD, is a pediatrician at Children’s Primary Care Medical Group in Carlsbad, Calif. She has no relevant financial disclosures.
Nutrition within the first 1,000 days of childhood are pivotal in a child’s neurodevelopment and lifelong health, according to an American Academy of Pediatrics policy statement.
“Healthy, normal neurodevelopment is a complex process involving cellular and structural changes in the brain that proceed in a specified sequence,” wrote Sara Jane Schwarzenberg, MD and Michael K. Georgieff, MD, both of the University of Minnesota Masonic Children’s Hospital, Minneapolis, and the AAP Committee on Nutrition. “Changes that are too rapid or too slow in one part of the brain may result in the failure of crucial pathway connections to other parts of the brain. Timing is crucial; once a particular developmental sequence fails, it may not be possible to retrieve all the lost function,” the investigators and committee noted in a report published in Pediatrics (Pediatrics. 2018; 141[2]:e20173716).
The importance of macronutrients was highlighted in a study of rural Guatemalan children during 1969-1989 who received high-calorie or low-calorie protein supplements. Children who received the high-calorie/high protein supplements before age 2 years had higher test scores, better reading and vocabulary skills, and faster information processing abilities, compared with their low-calorie/low-protein counterparts.
Like the low-calorie/low-protein Guatemalans, there are many populations that lack access to high-quality macronutrient sources or have access to only low-quality macronutrients. In the United States in 2015, 16.6% of households (6.4 million) were food insecure. This was even more pronounced in households with incomes below the poverty line, with 36.8% being food insecure, according to studies from the Department of Agriculture.
Food insecurity is not limited to macronutrients but extends to micronutrients such as vitamins and minerals like zinc; iron; choline; folate; iodine; vitamins A, D, B6, and B12; and long-chain polyunsaturated fatty acids. A lack of any of these micronutrients in early childhood can lead to neurodevelopmental issues later in life, Dr. Schwarzenberg, Dr. Georgieff, and the committee emphasized. An important source of micronutrients is human milk, provided by breastfeeding. Studies have shown that breastfeeding of preterm and term infants improves cognitive performance, compared with infants who consume formula (J Pediatr. 2016;177:133-9.e1; Curr Opin Pediatr. 2016;28[4]:559-66).
Because proper consumption of macronutrients and micronutrients is so important, a number of government-sponsored programs exist that provide nutritional support to women, infants, and young children. The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) is one of the most important programs, helping 53% of children under the age of 1 year. The Supplemental Nutrition Assistance Program (SNAP) also supplies economic aid to buy nutritious foods; it kept approximately 4.9 million children out of poverty in 2012, the researchers said. SNAP Nutrition Education, a partnership between SNAP and the Department of Agriculture, gives SNAP participants and eligible nonparticipants skills and information to help them to make healthy food choices with limited money.
The article highlights some important information, but is not an exhaustive discussion of the AAP policy statement. To make the information from the policy statement more applicable, Dr. Schwarzenberg, Dr. Georgieff, and the committee provided 10 takeaway recommendations for pediatricians.
1. Be knowledgeable about breastfeeding and help breastfeeding mothers. The AAP recommends exclusive breastfeeding for the first 6 months of a child’s life and to continue breastfeeding with the addition of food for at least the first year of life, and even after that if the mother and child so desire.
2. Advocate at the local, state, and federal levels to preserve and strengthen nutritional and assistance programs focusing on prenatal and neonatal nutrition. This can help support proper neurodevelopment and minimize negative environmental factors.
3. Openly discuss proper nutritions effects on infant neurodevelopment with parents. Know which nutrients are at risk in the breastfed infant after 6 months, such as zinc, iron, and vitamin D. A good resource is “Pediatric Nutrition, 7th edition” (Itasca, Ill. American Academy of Pediatrics, 2014).
4. Convey that eating healthy is a positive choice, not just an avoidance of unhealthy foods.
5. Inform food pantries and soup kitchens that the food packages and meals they provide should have higher levels of macronutrients and micronutrients.
6. Encourage parents to make use of programs like WIC and SNAP, and advocate for removing barriers that parents face in enrolling or reenrolling in such programs.
7. Oppose changes in eligibility to assistance programs that would adversely affect children.
8. Anticipate neurodevelopmental issues with children and address the issue early. For example, educate yourself about which nutrients are at risk for deficiency and at what ages.
9. Work with obstetricians to encourage improvements in maternal diet, which will affect the micronutrients available for the developing fetus.
10. Become advocates in the “Hunger Community,” working to reduce hunger at the local level across the United States. A chart in the article lists organizations focused on hunger, such as Feeding America, 1,000 Days, Share Our Strength, and others.
There was no external funding for this research, and the authors had no relevant financial disclosures or potential conflicts of interest to report.
Nutrition within the first 1,000 days of childhood are pivotal in a child’s neurodevelopment and lifelong health, according to an American Academy of Pediatrics policy statement.
“Healthy, normal neurodevelopment is a complex process involving cellular and structural changes in the brain that proceed in a specified sequence,” wrote Sara Jane Schwarzenberg, MD and Michael K. Georgieff, MD, both of the University of Minnesota Masonic Children’s Hospital, Minneapolis, and the AAP Committee on Nutrition. “Changes that are too rapid or too slow in one part of the brain may result in the failure of crucial pathway connections to other parts of the brain. Timing is crucial; once a particular developmental sequence fails, it may not be possible to retrieve all the lost function,” the investigators and committee noted in a report published in Pediatrics (Pediatrics. 2018; 141[2]:e20173716).
The importance of macronutrients was highlighted in a study of rural Guatemalan children during 1969-1989 who received high-calorie or low-calorie protein supplements. Children who received the high-calorie/high protein supplements before age 2 years had higher test scores, better reading and vocabulary skills, and faster information processing abilities, compared with their low-calorie/low-protein counterparts.
Like the low-calorie/low-protein Guatemalans, there are many populations that lack access to high-quality macronutrient sources or have access to only low-quality macronutrients. In the United States in 2015, 16.6% of households (6.4 million) were food insecure. This was even more pronounced in households with incomes below the poverty line, with 36.8% being food insecure, according to studies from the Department of Agriculture.
Food insecurity is not limited to macronutrients but extends to micronutrients such as vitamins and minerals like zinc; iron; choline; folate; iodine; vitamins A, D, B6, and B12; and long-chain polyunsaturated fatty acids. A lack of any of these micronutrients in early childhood can lead to neurodevelopmental issues later in life, Dr. Schwarzenberg, Dr. Georgieff, and the committee emphasized. An important source of micronutrients is human milk, provided by breastfeeding. Studies have shown that breastfeeding of preterm and term infants improves cognitive performance, compared with infants who consume formula (J Pediatr. 2016;177:133-9.e1; Curr Opin Pediatr. 2016;28[4]:559-66).
Because proper consumption of macronutrients and micronutrients is so important, a number of government-sponsored programs exist that provide nutritional support to women, infants, and young children. The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) is one of the most important programs, helping 53% of children under the age of 1 year. The Supplemental Nutrition Assistance Program (SNAP) also supplies economic aid to buy nutritious foods; it kept approximately 4.9 million children out of poverty in 2012, the researchers said. SNAP Nutrition Education, a partnership between SNAP and the Department of Agriculture, gives SNAP participants and eligible nonparticipants skills and information to help them to make healthy food choices with limited money.
The article highlights some important information, but is not an exhaustive discussion of the AAP policy statement. To make the information from the policy statement more applicable, Dr. Schwarzenberg, Dr. Georgieff, and the committee provided 10 takeaway recommendations for pediatricians.
1. Be knowledgeable about breastfeeding and help breastfeeding mothers. The AAP recommends exclusive breastfeeding for the first 6 months of a child’s life and to continue breastfeeding with the addition of food for at least the first year of life, and even after that if the mother and child so desire.
2. Advocate at the local, state, and federal levels to preserve and strengthen nutritional and assistance programs focusing on prenatal and neonatal nutrition. This can help support proper neurodevelopment and minimize negative environmental factors.
3. Openly discuss proper nutritions effects on infant neurodevelopment with parents. Know which nutrients are at risk in the breastfed infant after 6 months, such as zinc, iron, and vitamin D. A good resource is “Pediatric Nutrition, 7th edition” (Itasca, Ill. American Academy of Pediatrics, 2014).
4. Convey that eating healthy is a positive choice, not just an avoidance of unhealthy foods.
5. Inform food pantries and soup kitchens that the food packages and meals they provide should have higher levels of macronutrients and micronutrients.
6. Encourage parents to make use of programs like WIC and SNAP, and advocate for removing barriers that parents face in enrolling or reenrolling in such programs.
7. Oppose changes in eligibility to assistance programs that would adversely affect children.
8. Anticipate neurodevelopmental issues with children and address the issue early. For example, educate yourself about which nutrients are at risk for deficiency and at what ages.
9. Work with obstetricians to encourage improvements in maternal diet, which will affect the micronutrients available for the developing fetus.
10. Become advocates in the “Hunger Community,” working to reduce hunger at the local level across the United States. A chart in the article lists organizations focused on hunger, such as Feeding America, 1,000 Days, Share Our Strength, and others.
There was no external funding for this research, and the authors had no relevant financial disclosures or potential conflicts of interest to report.
FROM PEDIATRICS
Hungry or what?
“She will eat when she is hungry.” That in so many words is the mantra of grandparents blessed with experience and common sense and of most pediatricians when consulting parents challenged with a picky eater. From birth, children understand the simple equation that to survive they must eat. With rare exception, the motivating power of hunger can be leveraged for success even with infants who have spent their first months relying on enteral feedings. I have written an entire book based solely on the premise that if you present a young child food she will eat it ... eventually (“Coping With a Picky Eater: A Guide for the Perplexed Parent” New York: Simon and Schuster, 1998).
But if we reverse the words to read, “When she is eating, she is hungry,” do we have an equally valid observation? I think we have ample evidence that it is not.
The result was a year-long odyssey of pumping that included consultations with five different lactation consultants in the first frustrating month and a half. She eventually received some comforting advice from a pediatrician who reassured her that there was little research to guide her and to “just feed him; trust your instincts.”
While it is unfortunately true that there is very little good science we can fall back on when counseling women who are struggling with breastfeeding, I wonder about the wisdom of telling this mother to trust her instincts. I guess my hesitancy is based on 40 years of primary care pediatrics in which I could generally count on the instincts of young children, but their parents’ not so much. While maternal intuition is generally superior to the paternal version, I am hesitant to rely totally on either when facing a clinical dilemma such as defining hunger.
What about the fussy baby who is comforted by just a pacifier? What is the difference? There are several explanations, but it will require introducing the concept of nutrition deficiency.
Most babies who are satisfied with just a nipple, be it silicone or flesh, simply find sucking a comfort measure. A few, and I am sure you have seen some of them, are overly patient. They seem to be saying, “I need the calories, but you’re a good mom and I enjoy sucking. I can wait. Some day, you may make more milk or give me a bottle.” In the worst-case scenarios, their patience leaves these babies so nutritionally deficient that they can slip into apathy and die.
There are no easy answers. As pediatricians, our job is to sort out those fussy “hungry” babies whose behavior means they are overtired from those who are nutritionally deficient, from those with a dysfunctional satiety center. Making the differentiation is difficult but much easier than helping parents ignore one of their instincts.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
“She will eat when she is hungry.” That in so many words is the mantra of grandparents blessed with experience and common sense and of most pediatricians when consulting parents challenged with a picky eater. From birth, children understand the simple equation that to survive they must eat. With rare exception, the motivating power of hunger can be leveraged for success even with infants who have spent their first months relying on enteral feedings. I have written an entire book based solely on the premise that if you present a young child food she will eat it ... eventually (“Coping With a Picky Eater: A Guide for the Perplexed Parent” New York: Simon and Schuster, 1998).
But if we reverse the words to read, “When she is eating, she is hungry,” do we have an equally valid observation? I think we have ample evidence that it is not.
The result was a year-long odyssey of pumping that included consultations with five different lactation consultants in the first frustrating month and a half. She eventually received some comforting advice from a pediatrician who reassured her that there was little research to guide her and to “just feed him; trust your instincts.”
While it is unfortunately true that there is very little good science we can fall back on when counseling women who are struggling with breastfeeding, I wonder about the wisdom of telling this mother to trust her instincts. I guess my hesitancy is based on 40 years of primary care pediatrics in which I could generally count on the instincts of young children, but their parents’ not so much. While maternal intuition is generally superior to the paternal version, I am hesitant to rely totally on either when facing a clinical dilemma such as defining hunger.
What about the fussy baby who is comforted by just a pacifier? What is the difference? There are several explanations, but it will require introducing the concept of nutrition deficiency.
Most babies who are satisfied with just a nipple, be it silicone or flesh, simply find sucking a comfort measure. A few, and I am sure you have seen some of them, are overly patient. They seem to be saying, “I need the calories, but you’re a good mom and I enjoy sucking. I can wait. Some day, you may make more milk or give me a bottle.” In the worst-case scenarios, their patience leaves these babies so nutritionally deficient that they can slip into apathy and die.
There are no easy answers. As pediatricians, our job is to sort out those fussy “hungry” babies whose behavior means they are overtired from those who are nutritionally deficient, from those with a dysfunctional satiety center. Making the differentiation is difficult but much easier than helping parents ignore one of their instincts.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
“She will eat when she is hungry.” That in so many words is the mantra of grandparents blessed with experience and common sense and of most pediatricians when consulting parents challenged with a picky eater. From birth, children understand the simple equation that to survive they must eat. With rare exception, the motivating power of hunger can be leveraged for success even with infants who have spent their first months relying on enteral feedings. I have written an entire book based solely on the premise that if you present a young child food she will eat it ... eventually (“Coping With a Picky Eater: A Guide for the Perplexed Parent” New York: Simon and Schuster, 1998).
But if we reverse the words to read, “When she is eating, she is hungry,” do we have an equally valid observation? I think we have ample evidence that it is not.
The result was a year-long odyssey of pumping that included consultations with five different lactation consultants in the first frustrating month and a half. She eventually received some comforting advice from a pediatrician who reassured her that there was little research to guide her and to “just feed him; trust your instincts.”
While it is unfortunately true that there is very little good science we can fall back on when counseling women who are struggling with breastfeeding, I wonder about the wisdom of telling this mother to trust her instincts. I guess my hesitancy is based on 40 years of primary care pediatrics in which I could generally count on the instincts of young children, but their parents’ not so much. While maternal intuition is generally superior to the paternal version, I am hesitant to rely totally on either when facing a clinical dilemma such as defining hunger.
What about the fussy baby who is comforted by just a pacifier? What is the difference? There are several explanations, but it will require introducing the concept of nutrition deficiency.
Most babies who are satisfied with just a nipple, be it silicone or flesh, simply find sucking a comfort measure. A few, and I am sure you have seen some of them, are overly patient. They seem to be saying, “I need the calories, but you’re a good mom and I enjoy sucking. I can wait. Some day, you may make more milk or give me a bottle.” In the worst-case scenarios, their patience leaves these babies so nutritionally deficient that they can slip into apathy and die.
There are no easy answers. As pediatricians, our job is to sort out those fussy “hungry” babies whose behavior means they are overtired from those who are nutritionally deficient, from those with a dysfunctional satiety center. Making the differentiation is difficult but much easier than helping parents ignore one of their instincts.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
When cloth diapers cause diaper dermatitis, think calcineurin inhibitors
, a reemerging complication of diaper dermatitis associated with use of cloth reusable diapers, wrote Rita Ramos Pinheiro, MD, of Hospital Santo António dos Capuchos, Lisbon, and her associates.
An otherwise healthy 18-month-old girl was referred to the dermatology clinic with a 9-month history of severe relapsing diaper dermatitis, which responded to topical clotrimazole and zinc oxide cream. Nondisposable cloth diapers were used. She returned with a rash unresponsive to barrier creams, topical antibiotics and antifungals, and a variety of topical corticosteroids.
Clinically, a diagnosis of granuloma gluteale infantum was suspected; this was confirmed by a skin biopsy of one of the nodules.
The parents declined to stop using cloth diapers, so general measures to alleviate diaper dermatitis were tried, including frequent diaper-free periods. All previous topical treatments were stopped. A 0.1% pimecrolimus cream applied daily for 1 month was well tolerated, and a more potent 0.03% tacrolimus cream then was applied; both medications are topical calcineurin inhibitors.
At 4 weeks, there was complete regression of the ulcerated lesions, with later thinning of the lesions. At the last examination, there remained only slightly hypopigmented residual patches.
The same general measures were continued, including use of barrier creams. The patient had a relapse at her 9-month follow-up, with three nodules occurring on the gluteal region; these resolved with application of topical tacrolimus cream for 1 week.
Although reusable cloth diapers are considered better for the environment and cheaper than disposable diapers, “purportedly” they are less absorbent than disposable diapers, the investigators said.
Characteristics of the clinical diagnosis of granuloma gluteale infantum are “red-purple to red-brown, round to oval, deep, firm nodules with central ulceration,” with a “classic distribution over the convexities of the gluteal region, sparing the inguinal folds,” Dr. Pinheiro and her associates observed. The case study is the first reporting the use of topical calcineurin inhibitors for treating granuloma gluteale infantum, the researchers asserted.
Read more at Pediatrics (2017 Jan 3. doi: 10.1542/peds.2016-2064).
, a reemerging complication of diaper dermatitis associated with use of cloth reusable diapers, wrote Rita Ramos Pinheiro, MD, of Hospital Santo António dos Capuchos, Lisbon, and her associates.
An otherwise healthy 18-month-old girl was referred to the dermatology clinic with a 9-month history of severe relapsing diaper dermatitis, which responded to topical clotrimazole and zinc oxide cream. Nondisposable cloth diapers were used. She returned with a rash unresponsive to barrier creams, topical antibiotics and antifungals, and a variety of topical corticosteroids.
Clinically, a diagnosis of granuloma gluteale infantum was suspected; this was confirmed by a skin biopsy of one of the nodules.
The parents declined to stop using cloth diapers, so general measures to alleviate diaper dermatitis were tried, including frequent diaper-free periods. All previous topical treatments were stopped. A 0.1% pimecrolimus cream applied daily for 1 month was well tolerated, and a more potent 0.03% tacrolimus cream then was applied; both medications are topical calcineurin inhibitors.
At 4 weeks, there was complete regression of the ulcerated lesions, with later thinning of the lesions. At the last examination, there remained only slightly hypopigmented residual patches.
The same general measures were continued, including use of barrier creams. The patient had a relapse at her 9-month follow-up, with three nodules occurring on the gluteal region; these resolved with application of topical tacrolimus cream for 1 week.
Although reusable cloth diapers are considered better for the environment and cheaper than disposable diapers, “purportedly” they are less absorbent than disposable diapers, the investigators said.
Characteristics of the clinical diagnosis of granuloma gluteale infantum are “red-purple to red-brown, round to oval, deep, firm nodules with central ulceration,” with a “classic distribution over the convexities of the gluteal region, sparing the inguinal folds,” Dr. Pinheiro and her associates observed. The case study is the first reporting the use of topical calcineurin inhibitors for treating granuloma gluteale infantum, the researchers asserted.
Read more at Pediatrics (2017 Jan 3. doi: 10.1542/peds.2016-2064).
, a reemerging complication of diaper dermatitis associated with use of cloth reusable diapers, wrote Rita Ramos Pinheiro, MD, of Hospital Santo António dos Capuchos, Lisbon, and her associates.
An otherwise healthy 18-month-old girl was referred to the dermatology clinic with a 9-month history of severe relapsing diaper dermatitis, which responded to topical clotrimazole and zinc oxide cream. Nondisposable cloth diapers were used. She returned with a rash unresponsive to barrier creams, topical antibiotics and antifungals, and a variety of topical corticosteroids.
Clinically, a diagnosis of granuloma gluteale infantum was suspected; this was confirmed by a skin biopsy of one of the nodules.
The parents declined to stop using cloth diapers, so general measures to alleviate diaper dermatitis were tried, including frequent diaper-free periods. All previous topical treatments were stopped. A 0.1% pimecrolimus cream applied daily for 1 month was well tolerated, and a more potent 0.03% tacrolimus cream then was applied; both medications are topical calcineurin inhibitors.
At 4 weeks, there was complete regression of the ulcerated lesions, with later thinning of the lesions. At the last examination, there remained only slightly hypopigmented residual patches.
The same general measures were continued, including use of barrier creams. The patient had a relapse at her 9-month follow-up, with three nodules occurring on the gluteal region; these resolved with application of topical tacrolimus cream for 1 week.
Although reusable cloth diapers are considered better for the environment and cheaper than disposable diapers, “purportedly” they are less absorbent than disposable diapers, the investigators said.
Characteristics of the clinical diagnosis of granuloma gluteale infantum are “red-purple to red-brown, round to oval, deep, firm nodules with central ulceration,” with a “classic distribution over the convexities of the gluteal region, sparing the inguinal folds,” Dr. Pinheiro and her associates observed. The case study is the first reporting the use of topical calcineurin inhibitors for treating granuloma gluteale infantum, the researchers asserted.
Read more at Pediatrics (2017 Jan 3. doi: 10.1542/peds.2016-2064).
FROM PEDIATRICS
Budesonide fails to cut deaths in preemies
The administration of inhaled budesonide to extremely preterm infants did not increase the risk of neurodevelopmental disability, but did increase mortality, in a study by Dirk Bassler, MD, of the University of Zürich and his associates.
An older study led by Dr. Bassler and published in the New England Journal of Medicine showed that inhaled budesonide significantly reduced the incidence of bronchopulmonary dysplasia, which has been linked to higher mortality and chronic respiratory and cardiovascular impairment (N Engl J Med. 2015;373:1497-506).
Systemic glucocorticoids have been linked to greater risk of neurodevelopmental disability, but only a few studies have examined the effect of inhaled glucocorticoids, such as budesonide, in preterm infants. These studies, including the earlier one by Dr. Bassler and his colleagues, were either small, covered a short period of time or involved late administering of the drug.
In the two studies by Dr. Bassler and his colleagues, 863 preterm infants between 23 weeks’ and just under 28 weeks’ gestation who required any form of positive-pressure respiratory support were randomized to receive inhaled budesonide (two puffs, 200 mcg per puff) or placebo every 12 hours. They began within 24 hours of birth and continued for the first 14 days of life. Following that, patients received 1 puff every 12 hours until they no longer required supplemental oxygen and positive-pressure support, or reached a postmenstrual age of 32 weeks.
The treatment resulted in a significant reduction in bronchopulmonary dysplasia at a postmenstrual age of 36 weeks (28.2% in the budesonide group vs. 37.4%; P = .01), in the older study.
In the new study, which was also published in the New England Journal of Medicine, Dr. Bassler and his associates found higher mortality (19.9% vs. 14.5%; relative risk, 1.37; 95% confidence interval, 1.01-1.86; P = .04) in the group of patients who had received inhaled budesonide. Additionally, at a corrected age of 18-22 months, surviving infants who received inhaled budesonide had a similar risk of neurodevelopmental disability as those patients who took the placebo.
Broadly speaking, 48.1% of infants who received budesonide had a neurodevelopmental disability, compared with 51.4% of infants who received placebo (RR adjusted for gestational age, 0.93; 95% CI, 0.80-1.09; P = .40). The two groups also had no statistically significant differences in their frequencies of cerebral palsy, blindness, hearing loss, or cognitive delay.
“There was no significant difference between the groups in adverse long-term outcomes in our study. However, the fact that fewer infants died in the placebo group than in the budesonide group complicates the interpretation of the treatment of budesonide,” the researchers wrote.
Supported by a grant from the European Union and by Chiesi Farmaceutici. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
SOURCE: N Engl J Med. 2018;378:148-57.
This is an important study regarding bronchopulmonary dysplasia prevention. The study suggests starting budesonide within 24 hours of life resulted in a lower rate of bronchopulmonary dysplasia than placebo but fewer infants died in the placebo group. A bigger question for me is “what is the evidence for starting inhaled steroids prior to neonatal intensive care unit discharge?” Pediatric pulmonologists would like to know if it decreases subsequent respiratory-related ER visits and readmissions.
This is an important study regarding bronchopulmonary dysplasia prevention. The study suggests starting budesonide within 24 hours of life resulted in a lower rate of bronchopulmonary dysplasia than placebo but fewer infants died in the placebo group. A bigger question for me is “what is the evidence for starting inhaled steroids prior to neonatal intensive care unit discharge?” Pediatric pulmonologists would like to know if it decreases subsequent respiratory-related ER visits and readmissions.
This is an important study regarding bronchopulmonary dysplasia prevention. The study suggests starting budesonide within 24 hours of life resulted in a lower rate of bronchopulmonary dysplasia than placebo but fewer infants died in the placebo group. A bigger question for me is “what is the evidence for starting inhaled steroids prior to neonatal intensive care unit discharge?” Pediatric pulmonologists would like to know if it decreases subsequent respiratory-related ER visits and readmissions.
The administration of inhaled budesonide to extremely preterm infants did not increase the risk of neurodevelopmental disability, but did increase mortality, in a study by Dirk Bassler, MD, of the University of Zürich and his associates.
An older study led by Dr. Bassler and published in the New England Journal of Medicine showed that inhaled budesonide significantly reduced the incidence of bronchopulmonary dysplasia, which has been linked to higher mortality and chronic respiratory and cardiovascular impairment (N Engl J Med. 2015;373:1497-506).
Systemic glucocorticoids have been linked to greater risk of neurodevelopmental disability, but only a few studies have examined the effect of inhaled glucocorticoids, such as budesonide, in preterm infants. These studies, including the earlier one by Dr. Bassler and his colleagues, were either small, covered a short period of time or involved late administering of the drug.
In the two studies by Dr. Bassler and his colleagues, 863 preterm infants between 23 weeks’ and just under 28 weeks’ gestation who required any form of positive-pressure respiratory support were randomized to receive inhaled budesonide (two puffs, 200 mcg per puff) or placebo every 12 hours. They began within 24 hours of birth and continued for the first 14 days of life. Following that, patients received 1 puff every 12 hours until they no longer required supplemental oxygen and positive-pressure support, or reached a postmenstrual age of 32 weeks.
The treatment resulted in a significant reduction in bronchopulmonary dysplasia at a postmenstrual age of 36 weeks (28.2% in the budesonide group vs. 37.4%; P = .01), in the older study.
In the new study, which was also published in the New England Journal of Medicine, Dr. Bassler and his associates found higher mortality (19.9% vs. 14.5%; relative risk, 1.37; 95% confidence interval, 1.01-1.86; P = .04) in the group of patients who had received inhaled budesonide. Additionally, at a corrected age of 18-22 months, surviving infants who received inhaled budesonide had a similar risk of neurodevelopmental disability as those patients who took the placebo.
Broadly speaking, 48.1% of infants who received budesonide had a neurodevelopmental disability, compared with 51.4% of infants who received placebo (RR adjusted for gestational age, 0.93; 95% CI, 0.80-1.09; P = .40). The two groups also had no statistically significant differences in their frequencies of cerebral palsy, blindness, hearing loss, or cognitive delay.
“There was no significant difference between the groups in adverse long-term outcomes in our study. However, the fact that fewer infants died in the placebo group than in the budesonide group complicates the interpretation of the treatment of budesonide,” the researchers wrote.
Supported by a grant from the European Union and by Chiesi Farmaceutici. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
SOURCE: N Engl J Med. 2018;378:148-57.
The administration of inhaled budesonide to extremely preterm infants did not increase the risk of neurodevelopmental disability, but did increase mortality, in a study by Dirk Bassler, MD, of the University of Zürich and his associates.
An older study led by Dr. Bassler and published in the New England Journal of Medicine showed that inhaled budesonide significantly reduced the incidence of bronchopulmonary dysplasia, which has been linked to higher mortality and chronic respiratory and cardiovascular impairment (N Engl J Med. 2015;373:1497-506).
Systemic glucocorticoids have been linked to greater risk of neurodevelopmental disability, but only a few studies have examined the effect of inhaled glucocorticoids, such as budesonide, in preterm infants. These studies, including the earlier one by Dr. Bassler and his colleagues, were either small, covered a short period of time or involved late administering of the drug.
In the two studies by Dr. Bassler and his colleagues, 863 preterm infants between 23 weeks’ and just under 28 weeks’ gestation who required any form of positive-pressure respiratory support were randomized to receive inhaled budesonide (two puffs, 200 mcg per puff) or placebo every 12 hours. They began within 24 hours of birth and continued for the first 14 days of life. Following that, patients received 1 puff every 12 hours until they no longer required supplemental oxygen and positive-pressure support, or reached a postmenstrual age of 32 weeks.
The treatment resulted in a significant reduction in bronchopulmonary dysplasia at a postmenstrual age of 36 weeks (28.2% in the budesonide group vs. 37.4%; P = .01), in the older study.
In the new study, which was also published in the New England Journal of Medicine, Dr. Bassler and his associates found higher mortality (19.9% vs. 14.5%; relative risk, 1.37; 95% confidence interval, 1.01-1.86; P = .04) in the group of patients who had received inhaled budesonide. Additionally, at a corrected age of 18-22 months, surviving infants who received inhaled budesonide had a similar risk of neurodevelopmental disability as those patients who took the placebo.
Broadly speaking, 48.1% of infants who received budesonide had a neurodevelopmental disability, compared with 51.4% of infants who received placebo (RR adjusted for gestational age, 0.93; 95% CI, 0.80-1.09; P = .40). The two groups also had no statistically significant differences in their frequencies of cerebral palsy, blindness, hearing loss, or cognitive delay.
“There was no significant difference between the groups in adverse long-term outcomes in our study. However, the fact that fewer infants died in the placebo group than in the budesonide group complicates the interpretation of the treatment of budesonide,” the researchers wrote.
Supported by a grant from the European Union and by Chiesi Farmaceutici. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
SOURCE: N Engl J Med. 2018;378:148-57.
FROM NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point:
Major finding: Nearly 20% of infants in the budesonide group died, compared with 14.5% of the placebo group.
Data source: Randomized, controlled trial of 863 extremely preterm infants.
Disclosures: Supported by a grant from the European Union and by Chiesi Farmaceutici. Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.
Source: N Engl J Med. 2018;378:148-57.
Disparities persist in infant safe sleep practices
Sleep-related deaths among infants in the United States decreased during the 1990s as a result of recommendations to place babies on their backs to sleep. However, the decline has leveled off in recent years, and health care providers should proactively counsel caregivers about safe sleep practices, wrote Jennifer M. Bombard, MSPH, of the Centers for Disease Control and Prevention and her colleagues in a study published online in the Morbidity and Mortality Weekly Report.
Overall, 22% of respondents from 32 states and New York City in 2015 reported placing babies in a position other than their backs to sleep. In addition, 61% of respondents from 14 states reported bed sharing, and 39% from 13 states and New York City reported using soft bedding, including bumper pads and thick blankets.
Unsafe sleep practices varied by maternal demographics; nonsupine sleep positioning was more likely among non-Hispanic blacks, individuals aged 25 years or younger, those with 12 years or less of education, and those participating in the Special Supplemental Nutrition Program for Women, Infants, and Children.
“These findings highlight the need to implement and evaluate interventions to continue improving safe sleep practices,” Ms. Bombard and her associates said.
They cited the Study of Attitudes and Factors Effecting Infant Care Practices, in which caregivers who received appropriate advice on safe sleep practices were significantly less likely to place infants in a nonsupine position to sleep. “Evidence-based approaches to increase use of safe sleep practices include developing health messages and educational tools for caregivers and educating health and child care professionals on safe sleep practices,” they noted.
The study was limited by several factors, including reliance on self reports and inclusion of only states with Pregnancy Risk Assessment Monitoring System records, the researchers said.
Ms. Bombard and her associates had no relevant financial disclosures.
SOURCE: Bombard J et al. MMWR. 2018 Jan 9. doi: 10.15585/mmwr.mm6701e1.
Sleep-related deaths among infants in the United States decreased during the 1990s as a result of recommendations to place babies on their backs to sleep. However, the decline has leveled off in recent years, and health care providers should proactively counsel caregivers about safe sleep practices, wrote Jennifer M. Bombard, MSPH, of the Centers for Disease Control and Prevention and her colleagues in a study published online in the Morbidity and Mortality Weekly Report.
Overall, 22% of respondents from 32 states and New York City in 2015 reported placing babies in a position other than their backs to sleep. In addition, 61% of respondents from 14 states reported bed sharing, and 39% from 13 states and New York City reported using soft bedding, including bumper pads and thick blankets.
Unsafe sleep practices varied by maternal demographics; nonsupine sleep positioning was more likely among non-Hispanic blacks, individuals aged 25 years or younger, those with 12 years or less of education, and those participating in the Special Supplemental Nutrition Program for Women, Infants, and Children.
“These findings highlight the need to implement and evaluate interventions to continue improving safe sleep practices,” Ms. Bombard and her associates said.
They cited the Study of Attitudes and Factors Effecting Infant Care Practices, in which caregivers who received appropriate advice on safe sleep practices were significantly less likely to place infants in a nonsupine position to sleep. “Evidence-based approaches to increase use of safe sleep practices include developing health messages and educational tools for caregivers and educating health and child care professionals on safe sleep practices,” they noted.
The study was limited by several factors, including reliance on self reports and inclusion of only states with Pregnancy Risk Assessment Monitoring System records, the researchers said.
Ms. Bombard and her associates had no relevant financial disclosures.
SOURCE: Bombard J et al. MMWR. 2018 Jan 9. doi: 10.15585/mmwr.mm6701e1.
Sleep-related deaths among infants in the United States decreased during the 1990s as a result of recommendations to place babies on their backs to sleep. However, the decline has leveled off in recent years, and health care providers should proactively counsel caregivers about safe sleep practices, wrote Jennifer M. Bombard, MSPH, of the Centers for Disease Control and Prevention and her colleagues in a study published online in the Morbidity and Mortality Weekly Report.
Overall, 22% of respondents from 32 states and New York City in 2015 reported placing babies in a position other than their backs to sleep. In addition, 61% of respondents from 14 states reported bed sharing, and 39% from 13 states and New York City reported using soft bedding, including bumper pads and thick blankets.
Unsafe sleep practices varied by maternal demographics; nonsupine sleep positioning was more likely among non-Hispanic blacks, individuals aged 25 years or younger, those with 12 years or less of education, and those participating in the Special Supplemental Nutrition Program for Women, Infants, and Children.
“These findings highlight the need to implement and evaluate interventions to continue improving safe sleep practices,” Ms. Bombard and her associates said.
They cited the Study of Attitudes and Factors Effecting Infant Care Practices, in which caregivers who received appropriate advice on safe sleep practices were significantly less likely to place infants in a nonsupine position to sleep. “Evidence-based approaches to increase use of safe sleep practices include developing health messages and educational tools for caregivers and educating health and child care professionals on safe sleep practices,” they noted.
The study was limited by several factors, including reliance on self reports and inclusion of only states with Pregnancy Risk Assessment Monitoring System records, the researchers said.
Ms. Bombard and her associates had no relevant financial disclosures.
SOURCE: Bombard J et al. MMWR. 2018 Jan 9. doi: 10.15585/mmwr.mm6701e1.
FROM MMWR
Key clinical point: Health care providers can improve safe sleep for babies by counseling caregivers.
Major finding: Of respondents from 32 states and New York City in 2015, 22% reported placing babies in a position other than their backs to sleep.
Study details: The data come from the 2009-2015 Pregnancy Risk Assessment Monitoring System.
Disclosures: The researchers had no relevant financial disclosures.
Source: Bombard J et al. MMWR 2018 Jan 9. doi: 10.15585/mmwr.mm6701e1.