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NIH launches HEAL Initiative to combat opioid crisis
The NIH HEAL (Helping to End Addiction Long-term) Initiative aims to bring together agencies across the federal government, as well as academic institutions, private industry, and patient advocates to find new solutions to address the current national health emergency.
“There are 15 initiatives altogether that are being put out that we think are pretty bold and should make a big difference in our understanding of what to do about this national public health crisis,” NIH Director Francis Collins, MD, said in an interview.
HEAL will investigate ways to reformulate existing treatments for opioid use disorder (OUD), to improve efficacy and extend their availability to more patients.
“Although there are effective medications for OUD (methadone, buprenorphine, and naltrexone), only a small percentage of individuals in the United States who would benefit receive these medications,” according to an editorial introducing the NIH HEAL Initiative published in JAMA (doi:10.1001/jama.2018.8826). “Even among those who have initiated these medications, about half will relapse within 6 months.”
The editorial was authored by Dr. Collins, Walter J. Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke, and Nora Volkow, MD, director of the National Institute on Drug Abuse.
For example, the current formulation of naltrexone lasts about a month within the body, Dr. Collins said in an interview. “If we had a 6-month version of that, I think it would be much more effective because oftentimes the relapses happen after a month or so, before people have fully gotten themselves on the ground.”
Better overdose antidotes are needed as well, he said, particularly for fentanyl overdose. “Narcan may not be strong enough for those long-lasting and very potent opioids like fentanyl,” he said.
HEAL also will seek a better understanding of neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome, which has become alarmingly common as more women of childbearing potential struggle with opioid addiction.
“Innovative methods to identify and treat newborns exposed to opioids, often along with other drugs, have the potential to improve both short- and long-term developmental outcomes in such children,” Dr. Collins and colleagues noted. “To determine better approaches, HEAL will expand Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW). This pilot study is designed to assess the prevalence of NOWS, understand current approaches to managing NOWS , and develop common approaches for larger-scale studies that will determine best practices for clinical care of infants with NOWS throughout the country.”
HEAL efforts also seek to find integrated approaches to OUD treatment.
“One particularly bold element is to put together a number of pilot projects that enable bringing together all of the ways in which we are trying to turn this epidemic around by making it possible to assess whether individuals who are addicted can be successfully treated and maintained in abstinence for long periods of time,” Dr. Collins said. “Right now, the success is not so great.
“Suppose we brought together all of the treatment programs – the primary care facilities, the emergency rooms, the fire departments, the social work experts, the health departments in the states, the local communities, the criminal justice system. We brought together all of those players in a research design where we can really see what was working. Could we do a lot more to turn this around than basically doing one of those at a time? There is this multisite idea of a national research effort, still somewhat in development, but to do integration of all of these efforts. I am pretty excited about that one.”
In looking for better ways to treat pain safely and effectively, “we need to understand how it is that people transition from acute pain to chronic pain … and what can we do increase the likelihood of recovery from acute pain without making that transition,” Dr. Collins said. “Then we need to identify additional novel targets for developing pain therapies, both devices and pharmaceuticals. We need better means of testing those ideas.”
In addition to gaining a better understanding of chronic pain, HEAL aims to investigate new nonaddictive pain treatments and find ways to expedite those treatments through the clinical pipeline, according to Dr. Collins and colleagues.
HEAL “lays the foundation for an innovative therapy-development pipeline through a planned new public-private partnership. In collaboration with biopharmaceutical groups, the Food and Drug Administration, and the Foundation for the NIH, the NIH will collect and evaluate treatment assets from academia and biopharmaceutical and device companies to coordinate and accelerate the development of effective treatments for pain and addiction,” they wrote.
SOURCE: Collins F et al, JAMA doi: 10.1001/jama.2018.8826.
The NIH HEAL (Helping to End Addiction Long-term) Initiative aims to bring together agencies across the federal government, as well as academic institutions, private industry, and patient advocates to find new solutions to address the current national health emergency.
“There are 15 initiatives altogether that are being put out that we think are pretty bold and should make a big difference in our understanding of what to do about this national public health crisis,” NIH Director Francis Collins, MD, said in an interview.
HEAL will investigate ways to reformulate existing treatments for opioid use disorder (OUD), to improve efficacy and extend their availability to more patients.
“Although there are effective medications for OUD (methadone, buprenorphine, and naltrexone), only a small percentage of individuals in the United States who would benefit receive these medications,” according to an editorial introducing the NIH HEAL Initiative published in JAMA (doi:10.1001/jama.2018.8826). “Even among those who have initiated these medications, about half will relapse within 6 months.”
The editorial was authored by Dr. Collins, Walter J. Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke, and Nora Volkow, MD, director of the National Institute on Drug Abuse.
For example, the current formulation of naltrexone lasts about a month within the body, Dr. Collins said in an interview. “If we had a 6-month version of that, I think it would be much more effective because oftentimes the relapses happen after a month or so, before people have fully gotten themselves on the ground.”
Better overdose antidotes are needed as well, he said, particularly for fentanyl overdose. “Narcan may not be strong enough for those long-lasting and very potent opioids like fentanyl,” he said.
HEAL also will seek a better understanding of neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome, which has become alarmingly common as more women of childbearing potential struggle with opioid addiction.
“Innovative methods to identify and treat newborns exposed to opioids, often along with other drugs, have the potential to improve both short- and long-term developmental outcomes in such children,” Dr. Collins and colleagues noted. “To determine better approaches, HEAL will expand Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW). This pilot study is designed to assess the prevalence of NOWS, understand current approaches to managing NOWS , and develop common approaches for larger-scale studies that will determine best practices for clinical care of infants with NOWS throughout the country.”
HEAL efforts also seek to find integrated approaches to OUD treatment.
“One particularly bold element is to put together a number of pilot projects that enable bringing together all of the ways in which we are trying to turn this epidemic around by making it possible to assess whether individuals who are addicted can be successfully treated and maintained in abstinence for long periods of time,” Dr. Collins said. “Right now, the success is not so great.
“Suppose we brought together all of the treatment programs – the primary care facilities, the emergency rooms, the fire departments, the social work experts, the health departments in the states, the local communities, the criminal justice system. We brought together all of those players in a research design where we can really see what was working. Could we do a lot more to turn this around than basically doing one of those at a time? There is this multisite idea of a national research effort, still somewhat in development, but to do integration of all of these efforts. I am pretty excited about that one.”
In looking for better ways to treat pain safely and effectively, “we need to understand how it is that people transition from acute pain to chronic pain … and what can we do increase the likelihood of recovery from acute pain without making that transition,” Dr. Collins said. “Then we need to identify additional novel targets for developing pain therapies, both devices and pharmaceuticals. We need better means of testing those ideas.”
In addition to gaining a better understanding of chronic pain, HEAL aims to investigate new nonaddictive pain treatments and find ways to expedite those treatments through the clinical pipeline, according to Dr. Collins and colleagues.
HEAL “lays the foundation for an innovative therapy-development pipeline through a planned new public-private partnership. In collaboration with biopharmaceutical groups, the Food and Drug Administration, and the Foundation for the NIH, the NIH will collect and evaluate treatment assets from academia and biopharmaceutical and device companies to coordinate and accelerate the development of effective treatments for pain and addiction,” they wrote.
SOURCE: Collins F et al, JAMA doi: 10.1001/jama.2018.8826.
The NIH HEAL (Helping to End Addiction Long-term) Initiative aims to bring together agencies across the federal government, as well as academic institutions, private industry, and patient advocates to find new solutions to address the current national health emergency.
“There are 15 initiatives altogether that are being put out that we think are pretty bold and should make a big difference in our understanding of what to do about this national public health crisis,” NIH Director Francis Collins, MD, said in an interview.
HEAL will investigate ways to reformulate existing treatments for opioid use disorder (OUD), to improve efficacy and extend their availability to more patients.
“Although there are effective medications for OUD (methadone, buprenorphine, and naltrexone), only a small percentage of individuals in the United States who would benefit receive these medications,” according to an editorial introducing the NIH HEAL Initiative published in JAMA (doi:10.1001/jama.2018.8826). “Even among those who have initiated these medications, about half will relapse within 6 months.”
The editorial was authored by Dr. Collins, Walter J. Koroshetz, MD, director of the National Institute of Neurological Disorders and Stroke, and Nora Volkow, MD, director of the National Institute on Drug Abuse.
For example, the current formulation of naltrexone lasts about a month within the body, Dr. Collins said in an interview. “If we had a 6-month version of that, I think it would be much more effective because oftentimes the relapses happen after a month or so, before people have fully gotten themselves on the ground.”
Better overdose antidotes are needed as well, he said, particularly for fentanyl overdose. “Narcan may not be strong enough for those long-lasting and very potent opioids like fentanyl,” he said.
HEAL also will seek a better understanding of neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence syndrome, which has become alarmingly common as more women of childbearing potential struggle with opioid addiction.
“Innovative methods to identify and treat newborns exposed to opioids, often along with other drugs, have the potential to improve both short- and long-term developmental outcomes in such children,” Dr. Collins and colleagues noted. “To determine better approaches, HEAL will expand Advancing Clinical Trials in Neonatal Opioid Withdrawal Syndrome (ACT NOW). This pilot study is designed to assess the prevalence of NOWS, understand current approaches to managing NOWS , and develop common approaches for larger-scale studies that will determine best practices for clinical care of infants with NOWS throughout the country.”
HEAL efforts also seek to find integrated approaches to OUD treatment.
“One particularly bold element is to put together a number of pilot projects that enable bringing together all of the ways in which we are trying to turn this epidemic around by making it possible to assess whether individuals who are addicted can be successfully treated and maintained in abstinence for long periods of time,” Dr. Collins said. “Right now, the success is not so great.
“Suppose we brought together all of the treatment programs – the primary care facilities, the emergency rooms, the fire departments, the social work experts, the health departments in the states, the local communities, the criminal justice system. We brought together all of those players in a research design where we can really see what was working. Could we do a lot more to turn this around than basically doing one of those at a time? There is this multisite idea of a national research effort, still somewhat in development, but to do integration of all of these efforts. I am pretty excited about that one.”
In looking for better ways to treat pain safely and effectively, “we need to understand how it is that people transition from acute pain to chronic pain … and what can we do increase the likelihood of recovery from acute pain without making that transition,” Dr. Collins said. “Then we need to identify additional novel targets for developing pain therapies, both devices and pharmaceuticals. We need better means of testing those ideas.”
In addition to gaining a better understanding of chronic pain, HEAL aims to investigate new nonaddictive pain treatments and find ways to expedite those treatments through the clinical pipeline, according to Dr. Collins and colleagues.
HEAL “lays the foundation for an innovative therapy-development pipeline through a planned new public-private partnership. In collaboration with biopharmaceutical groups, the Food and Drug Administration, and the Foundation for the NIH, the NIH will collect and evaluate treatment assets from academia and biopharmaceutical and device companies to coordinate and accelerate the development of effective treatments for pain and addiction,” they wrote.
SOURCE: Collins F et al, JAMA doi: 10.1001/jama.2018.8826.
FROM JAMA
App found to improve quality of life for families of premature infants
TORONTO – Significant improvement in quality of life was observed in neonatal ICU families using the PreeMe+You app, preliminary results from a two-center study showed.
“NICU time is stressful,” one of the study authors, Abigail Whitney, said at the Pediatric Academic Societies annual meeting. “With the birth of a preterm infant, parents are often quickly transitioned into the role of becoming a parent much sooner and in much different circumstances than they might have anticipated. Parents have reported feelings of isolation, alienation, and insecurity in the parental role while in the NICU. Studies have shown that interventions that engage parents in their infant’s progress can decrease parental stress and anxiety, increase positive parent-infant interaction, and even reduce the infant’s length of stay. Also, with advancing technology there has been a push to find ways to use mobile technology to help parents balance engaging with their infant with the rest of their busy lives.”
In a study overseen by PreeMe+You’s chief medical expert, Bree Andrews, MD, MPH, Ms. Whitney and her associates administered the app to 48 families at either the University of Chicago Medicine Comer Children’s Hospital NICU or the Evanston Hospital NICU to assess readiness for using mobile technologies at the bedside. All families were recommended by a child life specialist who identified families who might be interested in using something like PreeMe+You. They excluded any families that were currently involved with child and family services, those with an infant younger than 7 days old, those whose child required escalation of care or upcoming surgeries, and those whose infant was over 37 weeks’ gestation.
First, the researchers briefed NICU staff about the study at charge nurse meetings, faculty meetings, and daily huddles for 2 weeks before first enrollment. “We did this knowing that parents might go to their nurses or doctors about how to answer specific questions within the app, or maybe want to learn more about a certain topic they learned from PreeMe+You,” Ms. Whitney said.
Data measurements included the PreeMe+You composite survey, which pulled questions from the Fragile Infant Parent Readiness Evaluation (FIPRE) and the NICU Parent Risk Evaluation and Engagement Model and Instrument (PREEMI). “We also included additional questions about technology use and capacity, as well as the PedsQL [Pediatric Quality of Life Inventory] Family Impact Module to assess parental quality of life throughout the study,” she said.
Over a period of 9 months, the researchers collected 153 quality of life measurements from 48 families. Of these, 48 occurred at enrollment, 23 occurred less than 1 week after enrollment, 30 occurred 1-2 weeks after enrollment, 28 occurred 3-4 weeks after enrollment, and 24 occurred 4 weeks or more after enrollment. By study closure, the researchers had follow-up data on 44 of the 48 families. The average gestational age at birth was 29.3 weeks, the average day of life at enrollment was 25.4, and the average birth weight was 1,280 grams.
On the app’s composite survey, 14.6% “agreed” and 79.2% “strongly agreed” that they were currently using a smart phone or tablet to look for information about preemies/NICU on the Internet, and about half “agreed” or “strongly agreed” (27.1% and 33.3%, respectively) that they spent more than 30 minutes per week looking up information about their NICU baby online. Nearly all families “agreed” or “strongly agreed” (14.6% and 85.4%) that they had a smart phone or tablet for Internet use in the NICU, and nearly all “agreed” or “strongly agreed” (33.3% and 62.5%) that having an app at the NICU bedside/home would be helpful. “This showed us that families were ready to use technology and interested in something like PreeMe+You at the bedside,” Ms. Whitney said.
At the time of study enrollment, 12 were in the purple stage, 8 were in the blue stage, 19 infants were in the orange stage, and 9 were in the yellow stage. Ms. Whitney reported that based on the PedsQL Family Impact Module, 35 of the 44 families showed increased quality of life functionality after participating in the study. This change was significant, with a P value of .001. Improvements were seen in the measure’s eight domains (physical, emotional, social, cognitive, communication, worry, daily activities, and family relationship functionality). “We saw increases across all of the domains based on how long the parents had been using the app,” Ms. Whitney said. “We found the biggest increase in quality of life in families of babies born less than 25 weeks’ gestational age, those born 25-26 weeks gestational age, those born 27-28 weeks gestational age, and those born 33-37 weeks gestational age. We are encouraged to see some of these quality of life changes in some of the earliest-born gestation babies because these are presumably the families that would have the longest time to go in the NICU and could benefit the most from using an app like PreeMe+You.”
She acknowledged certain limitations of the study, including the fact that it was conducted in two NICUs, “and we definitely need more comparisons to look at the natural trajectory of quality of life changes while families are in the NICU. Also, all of the families enrolled in our study had access to a research team that checked in with them weekly. In the real world, PreeMe+You would probably be self-guided.” Going forward, PreeMe+You plans to include additional features to give parents more self-guidance, making it easier for them to interact and partner with their baby’s medical team.
Funding for the study was provided by the Bucksbaum Institute for Clinical Excellence. Ms. Whitney was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases.
TORONTO – Significant improvement in quality of life was observed in neonatal ICU families using the PreeMe+You app, preliminary results from a two-center study showed.
“NICU time is stressful,” one of the study authors, Abigail Whitney, said at the Pediatric Academic Societies annual meeting. “With the birth of a preterm infant, parents are often quickly transitioned into the role of becoming a parent much sooner and in much different circumstances than they might have anticipated. Parents have reported feelings of isolation, alienation, and insecurity in the parental role while in the NICU. Studies have shown that interventions that engage parents in their infant’s progress can decrease parental stress and anxiety, increase positive parent-infant interaction, and even reduce the infant’s length of stay. Also, with advancing technology there has been a push to find ways to use mobile technology to help parents balance engaging with their infant with the rest of their busy lives.”
In a study overseen by PreeMe+You’s chief medical expert, Bree Andrews, MD, MPH, Ms. Whitney and her associates administered the app to 48 families at either the University of Chicago Medicine Comer Children’s Hospital NICU or the Evanston Hospital NICU to assess readiness for using mobile technologies at the bedside. All families were recommended by a child life specialist who identified families who might be interested in using something like PreeMe+You. They excluded any families that were currently involved with child and family services, those with an infant younger than 7 days old, those whose child required escalation of care or upcoming surgeries, and those whose infant was over 37 weeks’ gestation.
First, the researchers briefed NICU staff about the study at charge nurse meetings, faculty meetings, and daily huddles for 2 weeks before first enrollment. “We did this knowing that parents might go to their nurses or doctors about how to answer specific questions within the app, or maybe want to learn more about a certain topic they learned from PreeMe+You,” Ms. Whitney said.
Data measurements included the PreeMe+You composite survey, which pulled questions from the Fragile Infant Parent Readiness Evaluation (FIPRE) and the NICU Parent Risk Evaluation and Engagement Model and Instrument (PREEMI). “We also included additional questions about technology use and capacity, as well as the PedsQL [Pediatric Quality of Life Inventory] Family Impact Module to assess parental quality of life throughout the study,” she said.
Over a period of 9 months, the researchers collected 153 quality of life measurements from 48 families. Of these, 48 occurred at enrollment, 23 occurred less than 1 week after enrollment, 30 occurred 1-2 weeks after enrollment, 28 occurred 3-4 weeks after enrollment, and 24 occurred 4 weeks or more after enrollment. By study closure, the researchers had follow-up data on 44 of the 48 families. The average gestational age at birth was 29.3 weeks, the average day of life at enrollment was 25.4, and the average birth weight was 1,280 grams.
On the app’s composite survey, 14.6% “agreed” and 79.2% “strongly agreed” that they were currently using a smart phone or tablet to look for information about preemies/NICU on the Internet, and about half “agreed” or “strongly agreed” (27.1% and 33.3%, respectively) that they spent more than 30 minutes per week looking up information about their NICU baby online. Nearly all families “agreed” or “strongly agreed” (14.6% and 85.4%) that they had a smart phone or tablet for Internet use in the NICU, and nearly all “agreed” or “strongly agreed” (33.3% and 62.5%) that having an app at the NICU bedside/home would be helpful. “This showed us that families were ready to use technology and interested in something like PreeMe+You at the bedside,” Ms. Whitney said.
At the time of study enrollment, 12 were in the purple stage, 8 were in the blue stage, 19 infants were in the orange stage, and 9 were in the yellow stage. Ms. Whitney reported that based on the PedsQL Family Impact Module, 35 of the 44 families showed increased quality of life functionality after participating in the study. This change was significant, with a P value of .001. Improvements were seen in the measure’s eight domains (physical, emotional, social, cognitive, communication, worry, daily activities, and family relationship functionality). “We saw increases across all of the domains based on how long the parents had been using the app,” Ms. Whitney said. “We found the biggest increase in quality of life in families of babies born less than 25 weeks’ gestational age, those born 25-26 weeks gestational age, those born 27-28 weeks gestational age, and those born 33-37 weeks gestational age. We are encouraged to see some of these quality of life changes in some of the earliest-born gestation babies because these are presumably the families that would have the longest time to go in the NICU and could benefit the most from using an app like PreeMe+You.”
She acknowledged certain limitations of the study, including the fact that it was conducted in two NICUs, “and we definitely need more comparisons to look at the natural trajectory of quality of life changes while families are in the NICU. Also, all of the families enrolled in our study had access to a research team that checked in with them weekly. In the real world, PreeMe+You would probably be self-guided.” Going forward, PreeMe+You plans to include additional features to give parents more self-guidance, making it easier for them to interact and partner with their baby’s medical team.
Funding for the study was provided by the Bucksbaum Institute for Clinical Excellence. Ms. Whitney was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases.
TORONTO – Significant improvement in quality of life was observed in neonatal ICU families using the PreeMe+You app, preliminary results from a two-center study showed.
“NICU time is stressful,” one of the study authors, Abigail Whitney, said at the Pediatric Academic Societies annual meeting. “With the birth of a preterm infant, parents are often quickly transitioned into the role of becoming a parent much sooner and in much different circumstances than they might have anticipated. Parents have reported feelings of isolation, alienation, and insecurity in the parental role while in the NICU. Studies have shown that interventions that engage parents in their infant’s progress can decrease parental stress and anxiety, increase positive parent-infant interaction, and even reduce the infant’s length of stay. Also, with advancing technology there has been a push to find ways to use mobile technology to help parents balance engaging with their infant with the rest of their busy lives.”
In a study overseen by PreeMe+You’s chief medical expert, Bree Andrews, MD, MPH, Ms. Whitney and her associates administered the app to 48 families at either the University of Chicago Medicine Comer Children’s Hospital NICU or the Evanston Hospital NICU to assess readiness for using mobile technologies at the bedside. All families were recommended by a child life specialist who identified families who might be interested in using something like PreeMe+You. They excluded any families that were currently involved with child and family services, those with an infant younger than 7 days old, those whose child required escalation of care or upcoming surgeries, and those whose infant was over 37 weeks’ gestation.
First, the researchers briefed NICU staff about the study at charge nurse meetings, faculty meetings, and daily huddles for 2 weeks before first enrollment. “We did this knowing that parents might go to their nurses or doctors about how to answer specific questions within the app, or maybe want to learn more about a certain topic they learned from PreeMe+You,” Ms. Whitney said.
Data measurements included the PreeMe+You composite survey, which pulled questions from the Fragile Infant Parent Readiness Evaluation (FIPRE) and the NICU Parent Risk Evaluation and Engagement Model and Instrument (PREEMI). “We also included additional questions about technology use and capacity, as well as the PedsQL [Pediatric Quality of Life Inventory] Family Impact Module to assess parental quality of life throughout the study,” she said.
Over a period of 9 months, the researchers collected 153 quality of life measurements from 48 families. Of these, 48 occurred at enrollment, 23 occurred less than 1 week after enrollment, 30 occurred 1-2 weeks after enrollment, 28 occurred 3-4 weeks after enrollment, and 24 occurred 4 weeks or more after enrollment. By study closure, the researchers had follow-up data on 44 of the 48 families. The average gestational age at birth was 29.3 weeks, the average day of life at enrollment was 25.4, and the average birth weight was 1,280 grams.
On the app’s composite survey, 14.6% “agreed” and 79.2% “strongly agreed” that they were currently using a smart phone or tablet to look for information about preemies/NICU on the Internet, and about half “agreed” or “strongly agreed” (27.1% and 33.3%, respectively) that they spent more than 30 minutes per week looking up information about their NICU baby online. Nearly all families “agreed” or “strongly agreed” (14.6% and 85.4%) that they had a smart phone or tablet for Internet use in the NICU, and nearly all “agreed” or “strongly agreed” (33.3% and 62.5%) that having an app at the NICU bedside/home would be helpful. “This showed us that families were ready to use technology and interested in something like PreeMe+You at the bedside,” Ms. Whitney said.
At the time of study enrollment, 12 were in the purple stage, 8 were in the blue stage, 19 infants were in the orange stage, and 9 were in the yellow stage. Ms. Whitney reported that based on the PedsQL Family Impact Module, 35 of the 44 families showed increased quality of life functionality after participating in the study. This change was significant, with a P value of .001. Improvements were seen in the measure’s eight domains (physical, emotional, social, cognitive, communication, worry, daily activities, and family relationship functionality). “We saw increases across all of the domains based on how long the parents had been using the app,” Ms. Whitney said. “We found the biggest increase in quality of life in families of babies born less than 25 weeks’ gestational age, those born 25-26 weeks gestational age, those born 27-28 weeks gestational age, and those born 33-37 weeks gestational age. We are encouraged to see some of these quality of life changes in some of the earliest-born gestation babies because these are presumably the families that would have the longest time to go in the NICU and could benefit the most from using an app like PreeMe+You.”
She acknowledged certain limitations of the study, including the fact that it was conducted in two NICUs, “and we definitely need more comparisons to look at the natural trajectory of quality of life changes while families are in the NICU. Also, all of the families enrolled in our study had access to a research team that checked in with them weekly. In the real world, PreeMe+You would probably be self-guided.” Going forward, PreeMe+You plans to include additional features to give parents more self-guidance, making it easier for them to interact and partner with their baby’s medical team.
Funding for the study was provided by the Bucksbaum Institute for Clinical Excellence. Ms. Whitney was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases.
REPORTING FROM PAS 2018
Key clinical point:
Major finding: In all, 35 of the 44 families showed increased quality of life functionality, based on the PedsQL Family Impact Module (P = .001).
Study details: A two-center study of 44 families with premature infants intended to assess readiness for using mobile technologies at the bedside.
Disclosures: Funding for the study was provided by the Bucksbaum Institute for Clinical Excellence. Ms. Whitney was supported by a grant from the National Institute of Diabetes and Digestive and Kidney Diseases.
Neonatal deaths lower in high-volume hospitals
AUSTIN, TEX. – A first look at the timing of neonatal deaths showed an association with weekend deliveries in one Texas county. However, birth weight and ethnicity attenuated the association, according to a recent study. Higher hospital volumes were associated with lower risk of neonatal deaths.
The retrospective, population-based cohort study, presented during the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, used data from birth certificates and infant death certificates in the state of Texas. The investigators, said Elizabeth Restrepo, PhD, chose to examine data from Tarrant County, Tex., which has historically had persistently high infant mortality rates; in 2013, she said, the infant mortality rate in that county was 7.11/1,000 births – the highest in the state for that year.
The first question Dr. Restrepo and her colleagues at Texas Women’s University, Denton, wanted to answer was whether there was an association between the risk of neonatal mortality and the day of the week of the birth. For this and the study’s other research questions, she and her colleagues looked at 2012 data, matching 32,140 birth certificate records with 92 infant death certificates.
The investigators found an independent association between the risk of neonatal death and whether the birth happened on a weekday (Monday at 7:00 a.m. through Friday at 6:59 p.m.), or on a weekend (Friday at 7:00 p.m. through Monday at 6:59 a.m.). However, once birth weight and ethnicity were controlled in the statistical analysis, the association was not statistically significant despite an odds ratio of 1.44 (95% confidence interval, 0.911-2.27; P = .119).
“Births in the 12 hospitals studied appear to have been organized to take place more frequently on the working weekday rather than weekend days,” wrote Dr. Restrepo and her colleagues in the poster accompanying the presentation. Although the study wasn’t designed to answer this particular question, Dr. Restrepo said in discussion during the poster session that planned deliveries, such as inductions and cesarean deliveries, are likely to happen during the week, while the case mix is wider on weekends. Patient characteristics, as well as staffing patterns, may come into play.
The researchers also asked whether birth volume at a given institution increases the odds of neonatal death on weekends. Here, they found a significant inverse relationship between hospital birth volume and neonatal deaths (r = –0.021; P less than .001). With each additional increase of 1% in the weekday birth rate, the odds of neonatal death dropped by approximately 7.4%.
Examining the Tarrant County data further, Dr. Restrepo and her colleagues found that the hospitals with higher birth volumes had a more even distribution of births across the days of the week, with resulting lower concentrations of births during the week (r = –.394; P less than .001).
To classify infant deaths, the investigators included only ICD-10 diagnoses classified as P-codes to capture deaths occurring in the first 28 days after birth, but excluding congenital problems that are incompatible with life or that usually cause early death.
The researchers reported that they had no conflicts of interest; the study was funded by a research enhancement program award from the Texas Women’s University Office of Research and Sponsored Programs.
SOURCE: Restrepo E et al. ACOG 2018, Abstract 22R.
AUSTIN, TEX. – A first look at the timing of neonatal deaths showed an association with weekend deliveries in one Texas county. However, birth weight and ethnicity attenuated the association, according to a recent study. Higher hospital volumes were associated with lower risk of neonatal deaths.
The retrospective, population-based cohort study, presented during the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, used data from birth certificates and infant death certificates in the state of Texas. The investigators, said Elizabeth Restrepo, PhD, chose to examine data from Tarrant County, Tex., which has historically had persistently high infant mortality rates; in 2013, she said, the infant mortality rate in that county was 7.11/1,000 births – the highest in the state for that year.
The first question Dr. Restrepo and her colleagues at Texas Women’s University, Denton, wanted to answer was whether there was an association between the risk of neonatal mortality and the day of the week of the birth. For this and the study’s other research questions, she and her colleagues looked at 2012 data, matching 32,140 birth certificate records with 92 infant death certificates.
The investigators found an independent association between the risk of neonatal death and whether the birth happened on a weekday (Monday at 7:00 a.m. through Friday at 6:59 p.m.), or on a weekend (Friday at 7:00 p.m. through Monday at 6:59 a.m.). However, once birth weight and ethnicity were controlled in the statistical analysis, the association was not statistically significant despite an odds ratio of 1.44 (95% confidence interval, 0.911-2.27; P = .119).
“Births in the 12 hospitals studied appear to have been organized to take place more frequently on the working weekday rather than weekend days,” wrote Dr. Restrepo and her colleagues in the poster accompanying the presentation. Although the study wasn’t designed to answer this particular question, Dr. Restrepo said in discussion during the poster session that planned deliveries, such as inductions and cesarean deliveries, are likely to happen during the week, while the case mix is wider on weekends. Patient characteristics, as well as staffing patterns, may come into play.
The researchers also asked whether birth volume at a given institution increases the odds of neonatal death on weekends. Here, they found a significant inverse relationship between hospital birth volume and neonatal deaths (r = –0.021; P less than .001). With each additional increase of 1% in the weekday birth rate, the odds of neonatal death dropped by approximately 7.4%.
Examining the Tarrant County data further, Dr. Restrepo and her colleagues found that the hospitals with higher birth volumes had a more even distribution of births across the days of the week, with resulting lower concentrations of births during the week (r = –.394; P less than .001).
To classify infant deaths, the investigators included only ICD-10 diagnoses classified as P-codes to capture deaths occurring in the first 28 days after birth, but excluding congenital problems that are incompatible with life or that usually cause early death.
The researchers reported that they had no conflicts of interest; the study was funded by a research enhancement program award from the Texas Women’s University Office of Research and Sponsored Programs.
SOURCE: Restrepo E et al. ACOG 2018, Abstract 22R.
AUSTIN, TEX. – A first look at the timing of neonatal deaths showed an association with weekend deliveries in one Texas county. However, birth weight and ethnicity attenuated the association, according to a recent study. Higher hospital volumes were associated with lower risk of neonatal deaths.
The retrospective, population-based cohort study, presented during the annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists, used data from birth certificates and infant death certificates in the state of Texas. The investigators, said Elizabeth Restrepo, PhD, chose to examine data from Tarrant County, Tex., which has historically had persistently high infant mortality rates; in 2013, she said, the infant mortality rate in that county was 7.11/1,000 births – the highest in the state for that year.
The first question Dr. Restrepo and her colleagues at Texas Women’s University, Denton, wanted to answer was whether there was an association between the risk of neonatal mortality and the day of the week of the birth. For this and the study’s other research questions, she and her colleagues looked at 2012 data, matching 32,140 birth certificate records with 92 infant death certificates.
The investigators found an independent association between the risk of neonatal death and whether the birth happened on a weekday (Monday at 7:00 a.m. through Friday at 6:59 p.m.), or on a weekend (Friday at 7:00 p.m. through Monday at 6:59 a.m.). However, once birth weight and ethnicity were controlled in the statistical analysis, the association was not statistically significant despite an odds ratio of 1.44 (95% confidence interval, 0.911-2.27; P = .119).
“Births in the 12 hospitals studied appear to have been organized to take place more frequently on the working weekday rather than weekend days,” wrote Dr. Restrepo and her colleagues in the poster accompanying the presentation. Although the study wasn’t designed to answer this particular question, Dr. Restrepo said in discussion during the poster session that planned deliveries, such as inductions and cesarean deliveries, are likely to happen during the week, while the case mix is wider on weekends. Patient characteristics, as well as staffing patterns, may come into play.
The researchers also asked whether birth volume at a given institution increases the odds of neonatal death on weekends. Here, they found a significant inverse relationship between hospital birth volume and neonatal deaths (r = –0.021; P less than .001). With each additional increase of 1% in the weekday birth rate, the odds of neonatal death dropped by approximately 7.4%.
Examining the Tarrant County data further, Dr. Restrepo and her colleagues found that the hospitals with higher birth volumes had a more even distribution of births across the days of the week, with resulting lower concentrations of births during the week (r = –.394; P less than .001).
To classify infant deaths, the investigators included only ICD-10 diagnoses classified as P-codes to capture deaths occurring in the first 28 days after birth, but excluding congenital problems that are incompatible with life or that usually cause early death.
The researchers reported that they had no conflicts of interest; the study was funded by a research enhancement program award from the Texas Women’s University Office of Research and Sponsored Programs.
SOURCE: Restrepo E et al. ACOG 2018, Abstract 22R.
REPORTING FROM ACOG 2018
Key clinical point: Neonatal deaths were lower in hospitals with higher delivery volumes.
Major finding: Higher weekday birth volumes were associated with lower risk of neonatal death (P = .002).
Study details: Retrospective cohort study of 92 neonatal deaths in a single Texas county in 2012.
Disclosures: The study was funded by Texas Women’s University. The authors reported that they had no relevant disclosures.
Source: Restrepo E et al. ACOG 2018, Abstract 22R.
Jump start immunizations in NICU
MALMO, SWEDEN – The neonatal intensive care unit often represents a lost opportunity to bring an infant fully up to date for recommended age-appropriate immunizations – but it needn’t be that way, Raymond C. Stetson, MD, declared at the annual meeting of the European Society for Paediatric Infectious Diseases.
“We were able to find that within our unit a small number of quality improvement measures enabled us to drastically increase our vaccination rate in this population. I think this shows that other units ought to be auditing their immunization rates, and if they find similar root causes of low rates our experience could be generalized to those units as well,” Dr. Stetson said.
It’s well established that premature infants are at increased risk for underimmunization. Dr. Stetson and his coinvestigators deemed the baseline 56% on-time immunization rate in their NICU patients to be unacceptable, because underimmunized infants are more vulnerable to vaccine-preventable illnesses after discharge. So using the quality improvement methodology known as DMAIC – for Define, Measure, Analyze, Improve, Control – the investigators surveyed Mayo NICU physicians and nurses and identified three root causes of the quality gap: lack of staff knowledge of the routine immunization schedule, lack of awareness of when a NICU patient’s vaccines were actually due, and parental vaccine hesitancy.
Session chair Karina Butler, MD, was clearly impressed.
“You make it sound so easy to get such an increment. What were the barriers and obstacles you ran into?” asked Dr. Butler of Temple Street Children’s University Hospital, Dublin.
“Certain providers in our group were a bit more hesitant about giving vaccines,” Dr. Stetson replied. “There had to be a lot of provider education to get them to use the resources we’d created. And parental vaccine hesitancy was a barrier for us. Of that 6% of infants who weren’t fully up to date at discharge, the majority of those were due to parental vaccine hesitancy. I think that’s still a barrier that’s going to need more work.”
Dr. Stetson reported having no relevant financial disclosures.
MALMO, SWEDEN – The neonatal intensive care unit often represents a lost opportunity to bring an infant fully up to date for recommended age-appropriate immunizations – but it needn’t be that way, Raymond C. Stetson, MD, declared at the annual meeting of the European Society for Paediatric Infectious Diseases.
“We were able to find that within our unit a small number of quality improvement measures enabled us to drastically increase our vaccination rate in this population. I think this shows that other units ought to be auditing their immunization rates, and if they find similar root causes of low rates our experience could be generalized to those units as well,” Dr. Stetson said.
It’s well established that premature infants are at increased risk for underimmunization. Dr. Stetson and his coinvestigators deemed the baseline 56% on-time immunization rate in their NICU patients to be unacceptable, because underimmunized infants are more vulnerable to vaccine-preventable illnesses after discharge. So using the quality improvement methodology known as DMAIC – for Define, Measure, Analyze, Improve, Control – the investigators surveyed Mayo NICU physicians and nurses and identified three root causes of the quality gap: lack of staff knowledge of the routine immunization schedule, lack of awareness of when a NICU patient’s vaccines were actually due, and parental vaccine hesitancy.
Session chair Karina Butler, MD, was clearly impressed.
“You make it sound so easy to get such an increment. What were the barriers and obstacles you ran into?” asked Dr. Butler of Temple Street Children’s University Hospital, Dublin.
“Certain providers in our group were a bit more hesitant about giving vaccines,” Dr. Stetson replied. “There had to be a lot of provider education to get them to use the resources we’d created. And parental vaccine hesitancy was a barrier for us. Of that 6% of infants who weren’t fully up to date at discharge, the majority of those were due to parental vaccine hesitancy. I think that’s still a barrier that’s going to need more work.”
Dr. Stetson reported having no relevant financial disclosures.
MALMO, SWEDEN – The neonatal intensive care unit often represents a lost opportunity to bring an infant fully up to date for recommended age-appropriate immunizations – but it needn’t be that way, Raymond C. Stetson, MD, declared at the annual meeting of the European Society for Paediatric Infectious Diseases.
“We were able to find that within our unit a small number of quality improvement measures enabled us to drastically increase our vaccination rate in this population. I think this shows that other units ought to be auditing their immunization rates, and if they find similar root causes of low rates our experience could be generalized to those units as well,” Dr. Stetson said.
It’s well established that premature infants are at increased risk for underimmunization. Dr. Stetson and his coinvestigators deemed the baseline 56% on-time immunization rate in their NICU patients to be unacceptable, because underimmunized infants are more vulnerable to vaccine-preventable illnesses after discharge. So using the quality improvement methodology known as DMAIC – for Define, Measure, Analyze, Improve, Control – the investigators surveyed Mayo NICU physicians and nurses and identified three root causes of the quality gap: lack of staff knowledge of the routine immunization schedule, lack of awareness of when a NICU patient’s vaccines were actually due, and parental vaccine hesitancy.
Session chair Karina Butler, MD, was clearly impressed.
“You make it sound so easy to get such an increment. What were the barriers and obstacles you ran into?” asked Dr. Butler of Temple Street Children’s University Hospital, Dublin.
“Certain providers in our group were a bit more hesitant about giving vaccines,” Dr. Stetson replied. “There had to be a lot of provider education to get them to use the resources we’d created. And parental vaccine hesitancy was a barrier for us. Of that 6% of infants who weren’t fully up to date at discharge, the majority of those were due to parental vaccine hesitancy. I think that’s still a barrier that’s going to need more work.”
Dr. Stetson reported having no relevant financial disclosures.
REPORTING FROM ESPID 2018
Key clinical point:
Major finding: Only 56% of 754 NICU patients from 2015 through mid-2017 were up to date for the ACIP-recommended vaccinations at discharge or transfer. After an intervention, the on-time immunization rate rose to 94% in 155 patients discharged during the first 6 months.
Study details: A study comparing 754 NICU patients prior to intervention and 155 after intervention.
Disclosures: Dr. Stetson reported having no relevant financial disclosures.
Source: Stetson R. E-Poster Discussion Session 04.
Behavioral sleep intervention linked to sleep improvement in infants
(BSI) in a real-world setting, Sarah M. Honaker, PhD, of Indiana University, Indianapolis, and her associates, reported in the Journal of Pediatrics.
In a study of 652 parents who participated, parents started BSI when their infants were as young as less than 1 month of age and as late as 18 months of age. Most parents started BSI at 3-5 months.
Crying generally was greatest the first night, occurring in 45% of cases when all BSI approaches were considered. It lasted a mean 43 minutes, which dropped significantly after 1 week to a mean 9 minutes (P less than .001). Crying was considered most intense (on a 1-5 scale) on the initial night of BSI, a mean 4.42, and this “was equally true for all of the BSI approaches,” Dr. Honaker and her colleagues wrote.
In most cases, the parents’ first attempt at BSI worked (83%). Success varied by BSI approach, with the highest first attempt success rate in the unmodified extinction group (90%), followed by parental presence without support (83%), modified extinction (81%), and parental presence with support (65%). Eventually, 27% of parents were successful with a different approach than the one with which they started. Most commonly, they changed from modified extinction to unmodified extinction (66% of those who changed approaches).
“The majority of parents report successfully implementing BSI at a variety of ages across infancy, primarily using extinction-based approaches,” the researchers concluded. “Few significant differences were found between approaches, suggesting that health providers should offer parents options for BSI implementation.”
SOURCE: Honaker SM et al., J Pediatr. 2018. doi: 10.1016/j.jpeds.2018.04.009.
(BSI) in a real-world setting, Sarah M. Honaker, PhD, of Indiana University, Indianapolis, and her associates, reported in the Journal of Pediatrics.
In a study of 652 parents who participated, parents started BSI when their infants were as young as less than 1 month of age and as late as 18 months of age. Most parents started BSI at 3-5 months.
Crying generally was greatest the first night, occurring in 45% of cases when all BSI approaches were considered. It lasted a mean 43 minutes, which dropped significantly after 1 week to a mean 9 minutes (P less than .001). Crying was considered most intense (on a 1-5 scale) on the initial night of BSI, a mean 4.42, and this “was equally true for all of the BSI approaches,” Dr. Honaker and her colleagues wrote.
In most cases, the parents’ first attempt at BSI worked (83%). Success varied by BSI approach, with the highest first attempt success rate in the unmodified extinction group (90%), followed by parental presence without support (83%), modified extinction (81%), and parental presence with support (65%). Eventually, 27% of parents were successful with a different approach than the one with which they started. Most commonly, they changed from modified extinction to unmodified extinction (66% of those who changed approaches).
“The majority of parents report successfully implementing BSI at a variety of ages across infancy, primarily using extinction-based approaches,” the researchers concluded. “Few significant differences were found between approaches, suggesting that health providers should offer parents options for BSI implementation.”
SOURCE: Honaker SM et al., J Pediatr. 2018. doi: 10.1016/j.jpeds.2018.04.009.
(BSI) in a real-world setting, Sarah M. Honaker, PhD, of Indiana University, Indianapolis, and her associates, reported in the Journal of Pediatrics.
In a study of 652 parents who participated, parents started BSI when their infants were as young as less than 1 month of age and as late as 18 months of age. Most parents started BSI at 3-5 months.
Crying generally was greatest the first night, occurring in 45% of cases when all BSI approaches were considered. It lasted a mean 43 minutes, which dropped significantly after 1 week to a mean 9 minutes (P less than .001). Crying was considered most intense (on a 1-5 scale) on the initial night of BSI, a mean 4.42, and this “was equally true for all of the BSI approaches,” Dr. Honaker and her colleagues wrote.
In most cases, the parents’ first attempt at BSI worked (83%). Success varied by BSI approach, with the highest first attempt success rate in the unmodified extinction group (90%), followed by parental presence without support (83%), modified extinction (81%), and parental presence with support (65%). Eventually, 27% of parents were successful with a different approach than the one with which they started. Most commonly, they changed from modified extinction to unmodified extinction (66% of those who changed approaches).
“The majority of parents report successfully implementing BSI at a variety of ages across infancy, primarily using extinction-based approaches,” the researchers concluded. “Few significant differences were found between approaches, suggesting that health providers should offer parents options for BSI implementation.”
SOURCE: Honaker SM et al., J Pediatr. 2018. doi: 10.1016/j.jpeds.2018.04.009.
FROM THE JOURNAL OF PEDIATRICS
Drug-related deaths continue to rise in United States
TORONTO – Drug-related deaths in America are rising faster than ever.
Rear Adm. Wanda D. Barfield, MD shared recent data from the U.S. National Center for Health Statistics on people aged 15 years and older at the Pediatric Academic Societies annual meeting. Between 1999 and 2016, for example, the number of drug overdose deaths rose more than threefold, from 6.1/100,000 standard population in 1999 to 19.8/100,000 in 2016. For males, the rate increased from 8.2/100,000 in 1999 to 26.2/100,000 in 2016. For females, the rate increased from 3.9/100,000 in 1999 to 13.4/100,000 in 2016.
Dr. Barfield, director of the division of reproductive health at the Centers for Disease Control and Prevention, said that in 2016, the NCHS also found that 22 states and the District of Columbia had drug overdoses that were significantly higher than the national average. The states with the highest number of drug overdose deaths were the District of Columbia, New Hampshire, Pennsylvania, and West Virginia while the states with the lowest observed rates were Nebraska, North Dakota, South Dakota, and Texas.
“Many of these drug overdose deaths are linked to opioids, but not exclusively,” Dr. Barfield said. “In the past, the overall opioid-related overdose deaths were mainly attributed to commonly prescribed opioid medications. However, in recent years, we’re seeing more deaths due to illicit drugs such as heroin and fentanyl.”
The NCHS found that the age-adjusted rate for drug overdose deaths involving synthetic opioids other than methadone doubled from 2015 to 2016, and that drug overdose deaths involving synthetic opioids other than methadone increased from 0.3/100,000 in 1999 to 6.2/100,000 in 2016. The rate increased an average of 18% per year from 1999 to 2006, remained steady from 2006 to 2013, but increased by 88% per year from 2013 to 2016. At the same time, drug overdose deaths involving heroin increased from 0.7/100,000 in 1999 to 1/100,000 in 2010, to 4.9/100,000 in 2016.
According to Dr. Barfield, the spike in opioid use since 1999 stems directly from increased prescribing rates. “In 2015, the number of opioids prescribed was enough so that every American could be medicated around the clock for 3 weeks,” she said. “In addition to the number of prescriptions, the average day’s supply of prescription opioids increased from 2006 to 2015, from 13.3 days in 2006 to 17.7 days in 2015.” What’s more, a recent CDC Vital Signs found that the amount of opioids prescribed per person varied widely among U.S. counties in 2015. “The wide variation among counties suggests a lack of consistency among providers when prescribing opioids,” Dr. Barfield said. “It’s concerning, as higher opioid prescribing puts patients at risk for addiction.”
At the same time, opioid overdose ED visits continue to rise. Data from the CDC’s National Syndromic Surveillance Program found that from July 2016 to September 2017, opioid overdose ED visits increased by 30% for men, by 24% for women, and for all adult age groups (31% among those aged 25-34 years, 36% among those aged 35-54 years, and 32% among those aged 55 years and older).
There’s a problem of prescription opioid use among pregnant women. Published estimates indicate that 14%-22% of women filled an opioid prescription during pregnancy, Dr. Barfield said. Among pregnant women, the prevalence of maternal opioid use or dependence during hospitalization for delivery has increased 127%, from 1.7 /1,000 delivery admissions in 1998 to 3.9/1,000 delivery admissions in 2011 (Anesthesiology 2014;121[6]:1158-65). There also has been a significant increase in neonatal abstinence syndrome (NAS), which is most commonly attributed to opioid exposure during pregnancy, from 1.2/1,000 U.S. hospital births in 2000 to 8/1,000 U.S. hospital births in 2014. “NAS is still on the rise,” Dr. Barfield said. “In 2012, we saw one baby with NAS born every 25 minutes. In 2014, that number jumped to one baby born with NAS every 15 minutes. That means about 96 infants with NAS are born daily,” she said. “Where do you think we’re going to be when we look at 2018 data?”
Role for pediatricians
Dr. Barfield closed her presentation by underscoring the role pediatricians play in counseling patients about opioid abuse or dependence during pregnancy. “We know that providers have a tremendous impact on patients and their families,” she said. “We also know that issues leading to a newborn having NAS are complex, so adopting a public health approach focused on prevention, expansion of treatment, and improvements in child welfare systems is vital.” Specifically, she said, health care providers can “bridge the gap” between clinical care and public health; lead in their communities, not just within their hospital or practice; work as a team member with colleagues in other fields of medicine such as obstetrics, family medicine, and addiction care when caring for infants with NAS, and by considering the social determinants of health.
“One way to adopt a public health perspective is to remember that the health of the fetus and baby rely on more than just prenatal care,” Dr. Barfield said. “We’re all part of a larger whole, surrounded by our families, communities, regions, state, and even our countries of origin. What’s going on with the mom, her family, and the larger community impacts the baby’s health. In other words, the social determinants of health matter, and are an important part of the conversation on NAS.”
She reported having no financial disclosures.
TORONTO – Drug-related deaths in America are rising faster than ever.
Rear Adm. Wanda D. Barfield, MD shared recent data from the U.S. National Center for Health Statistics on people aged 15 years and older at the Pediatric Academic Societies annual meeting. Between 1999 and 2016, for example, the number of drug overdose deaths rose more than threefold, from 6.1/100,000 standard population in 1999 to 19.8/100,000 in 2016. For males, the rate increased from 8.2/100,000 in 1999 to 26.2/100,000 in 2016. For females, the rate increased from 3.9/100,000 in 1999 to 13.4/100,000 in 2016.
Dr. Barfield, director of the division of reproductive health at the Centers for Disease Control and Prevention, said that in 2016, the NCHS also found that 22 states and the District of Columbia had drug overdoses that were significantly higher than the national average. The states with the highest number of drug overdose deaths were the District of Columbia, New Hampshire, Pennsylvania, and West Virginia while the states with the lowest observed rates were Nebraska, North Dakota, South Dakota, and Texas.
“Many of these drug overdose deaths are linked to opioids, but not exclusively,” Dr. Barfield said. “In the past, the overall opioid-related overdose deaths were mainly attributed to commonly prescribed opioid medications. However, in recent years, we’re seeing more deaths due to illicit drugs such as heroin and fentanyl.”
The NCHS found that the age-adjusted rate for drug overdose deaths involving synthetic opioids other than methadone doubled from 2015 to 2016, and that drug overdose deaths involving synthetic opioids other than methadone increased from 0.3/100,000 in 1999 to 6.2/100,000 in 2016. The rate increased an average of 18% per year from 1999 to 2006, remained steady from 2006 to 2013, but increased by 88% per year from 2013 to 2016. At the same time, drug overdose deaths involving heroin increased from 0.7/100,000 in 1999 to 1/100,000 in 2010, to 4.9/100,000 in 2016.
According to Dr. Barfield, the spike in opioid use since 1999 stems directly from increased prescribing rates. “In 2015, the number of opioids prescribed was enough so that every American could be medicated around the clock for 3 weeks,” she said. “In addition to the number of prescriptions, the average day’s supply of prescription opioids increased from 2006 to 2015, from 13.3 days in 2006 to 17.7 days in 2015.” What’s more, a recent CDC Vital Signs found that the amount of opioids prescribed per person varied widely among U.S. counties in 2015. “The wide variation among counties suggests a lack of consistency among providers when prescribing opioids,” Dr. Barfield said. “It’s concerning, as higher opioid prescribing puts patients at risk for addiction.”
At the same time, opioid overdose ED visits continue to rise. Data from the CDC’s National Syndromic Surveillance Program found that from July 2016 to September 2017, opioid overdose ED visits increased by 30% for men, by 24% for women, and for all adult age groups (31% among those aged 25-34 years, 36% among those aged 35-54 years, and 32% among those aged 55 years and older).
There’s a problem of prescription opioid use among pregnant women. Published estimates indicate that 14%-22% of women filled an opioid prescription during pregnancy, Dr. Barfield said. Among pregnant women, the prevalence of maternal opioid use or dependence during hospitalization for delivery has increased 127%, from 1.7 /1,000 delivery admissions in 1998 to 3.9/1,000 delivery admissions in 2011 (Anesthesiology 2014;121[6]:1158-65). There also has been a significant increase in neonatal abstinence syndrome (NAS), which is most commonly attributed to opioid exposure during pregnancy, from 1.2/1,000 U.S. hospital births in 2000 to 8/1,000 U.S. hospital births in 2014. “NAS is still on the rise,” Dr. Barfield said. “In 2012, we saw one baby with NAS born every 25 minutes. In 2014, that number jumped to one baby born with NAS every 15 minutes. That means about 96 infants with NAS are born daily,” she said. “Where do you think we’re going to be when we look at 2018 data?”
Role for pediatricians
Dr. Barfield closed her presentation by underscoring the role pediatricians play in counseling patients about opioid abuse or dependence during pregnancy. “We know that providers have a tremendous impact on patients and their families,” she said. “We also know that issues leading to a newborn having NAS are complex, so adopting a public health approach focused on prevention, expansion of treatment, and improvements in child welfare systems is vital.” Specifically, she said, health care providers can “bridge the gap” between clinical care and public health; lead in their communities, not just within their hospital or practice; work as a team member with colleagues in other fields of medicine such as obstetrics, family medicine, and addiction care when caring for infants with NAS, and by considering the social determinants of health.
“One way to adopt a public health perspective is to remember that the health of the fetus and baby rely on more than just prenatal care,” Dr. Barfield said. “We’re all part of a larger whole, surrounded by our families, communities, regions, state, and even our countries of origin. What’s going on with the mom, her family, and the larger community impacts the baby’s health. In other words, the social determinants of health matter, and are an important part of the conversation on NAS.”
She reported having no financial disclosures.
TORONTO – Drug-related deaths in America are rising faster than ever.
Rear Adm. Wanda D. Barfield, MD shared recent data from the U.S. National Center for Health Statistics on people aged 15 years and older at the Pediatric Academic Societies annual meeting. Between 1999 and 2016, for example, the number of drug overdose deaths rose more than threefold, from 6.1/100,000 standard population in 1999 to 19.8/100,000 in 2016. For males, the rate increased from 8.2/100,000 in 1999 to 26.2/100,000 in 2016. For females, the rate increased from 3.9/100,000 in 1999 to 13.4/100,000 in 2016.
Dr. Barfield, director of the division of reproductive health at the Centers for Disease Control and Prevention, said that in 2016, the NCHS also found that 22 states and the District of Columbia had drug overdoses that were significantly higher than the national average. The states with the highest number of drug overdose deaths were the District of Columbia, New Hampshire, Pennsylvania, and West Virginia while the states with the lowest observed rates were Nebraska, North Dakota, South Dakota, and Texas.
“Many of these drug overdose deaths are linked to opioids, but not exclusively,” Dr. Barfield said. “In the past, the overall opioid-related overdose deaths were mainly attributed to commonly prescribed opioid medications. However, in recent years, we’re seeing more deaths due to illicit drugs such as heroin and fentanyl.”
The NCHS found that the age-adjusted rate for drug overdose deaths involving synthetic opioids other than methadone doubled from 2015 to 2016, and that drug overdose deaths involving synthetic opioids other than methadone increased from 0.3/100,000 in 1999 to 6.2/100,000 in 2016. The rate increased an average of 18% per year from 1999 to 2006, remained steady from 2006 to 2013, but increased by 88% per year from 2013 to 2016. At the same time, drug overdose deaths involving heroin increased from 0.7/100,000 in 1999 to 1/100,000 in 2010, to 4.9/100,000 in 2016.
According to Dr. Barfield, the spike in opioid use since 1999 stems directly from increased prescribing rates. “In 2015, the number of opioids prescribed was enough so that every American could be medicated around the clock for 3 weeks,” she said. “In addition to the number of prescriptions, the average day’s supply of prescription opioids increased from 2006 to 2015, from 13.3 days in 2006 to 17.7 days in 2015.” What’s more, a recent CDC Vital Signs found that the amount of opioids prescribed per person varied widely among U.S. counties in 2015. “The wide variation among counties suggests a lack of consistency among providers when prescribing opioids,” Dr. Barfield said. “It’s concerning, as higher opioid prescribing puts patients at risk for addiction.”
At the same time, opioid overdose ED visits continue to rise. Data from the CDC’s National Syndromic Surveillance Program found that from July 2016 to September 2017, opioid overdose ED visits increased by 30% for men, by 24% for women, and for all adult age groups (31% among those aged 25-34 years, 36% among those aged 35-54 years, and 32% among those aged 55 years and older).
There’s a problem of prescription opioid use among pregnant women. Published estimates indicate that 14%-22% of women filled an opioid prescription during pregnancy, Dr. Barfield said. Among pregnant women, the prevalence of maternal opioid use or dependence during hospitalization for delivery has increased 127%, from 1.7 /1,000 delivery admissions in 1998 to 3.9/1,000 delivery admissions in 2011 (Anesthesiology 2014;121[6]:1158-65). There also has been a significant increase in neonatal abstinence syndrome (NAS), which is most commonly attributed to opioid exposure during pregnancy, from 1.2/1,000 U.S. hospital births in 2000 to 8/1,000 U.S. hospital births in 2014. “NAS is still on the rise,” Dr. Barfield said. “In 2012, we saw one baby with NAS born every 25 minutes. In 2014, that number jumped to one baby born with NAS every 15 minutes. That means about 96 infants with NAS are born daily,” she said. “Where do you think we’re going to be when we look at 2018 data?”
Role for pediatricians
Dr. Barfield closed her presentation by underscoring the role pediatricians play in counseling patients about opioid abuse or dependence during pregnancy. “We know that providers have a tremendous impact on patients and their families,” she said. “We also know that issues leading to a newborn having NAS are complex, so adopting a public health approach focused on prevention, expansion of treatment, and improvements in child welfare systems is vital.” Specifically, she said, health care providers can “bridge the gap” between clinical care and public health; lead in their communities, not just within their hospital or practice; work as a team member with colleagues in other fields of medicine such as obstetrics, family medicine, and addiction care when caring for infants with NAS, and by considering the social determinants of health.
“One way to adopt a public health perspective is to remember that the health of the fetus and baby rely on more than just prenatal care,” Dr. Barfield said. “We’re all part of a larger whole, surrounded by our families, communities, regions, state, and even our countries of origin. What’s going on with the mom, her family, and the larger community impacts the baby’s health. In other words, the social determinants of health matter, and are an important part of the conversation on NAS.”
She reported having no financial disclosures.
EXPERT ANALYSIS FROM PAS 2018
Which infants with invasive bacterial infections are at risk for adverse outcomes?
TORONTO – Among infants up to 60 days old with an invasive bacterial infection, adverse outcomes are associated with prematurity, ill appearance, and bacterial meningitis, a multicenter retrospective analysis found.
“Young infants are susceptible to serious bacterial infections, particularly when they’re less than 60 days of age,” Christopher Pruitt, MD, said at the annual Pediatric Academic Societies meeting. “Among these infants, bacteremia and bacterial meningitis, also referred to as invasive bacterial infections, are associated with higher rates of morbidity and mortality.”
The primary outcome measure was occurrence of an adverse clinical outcome within 30 days following the index ED visit. Adverse outcomes were defined as use of mechanical ventilation, vasoactive medications, any neurologic sequelae, and death. The researchers used a mixed-effects logistic regression model and retained covariates with a P value of less than .10. Covariates analyzed included age less than 28 days, prematurity, presence or absence of a complex chronic condition, presence of fever, ill appearance, bacterial meningitis, and concordant empiric antimicrobial therapy.
Of the 442 infants included in the final analysis, the majority (80%) had bacteremia, 14% had bacterial meningitis plus bacteremia, and 6% had bacterial meningitis only. “For purposes of this study, patients with bacterial meningitis with or without bacteremia were categorized as having bacterial meningitis,” Dr. Pruitt said. He and his associates found that 14.5% of infants had one or more adverse outcomes. Adverse outcomes occurred in 39% of infants with bacterial meningitis, compared with 8.2% of infants with isolated bacteremia. Need for mechanical ventilation, vasoactive medications, and neurologic disability also was more common among infants with bacterial meningitis than it was among children with isolated bacteremia. There were 10 deaths overall, which amounted to about 2% in both groups.
On multivariate analysis, the rate of adverse outcomes was significantly higher for patients with bacterial meningitis than it was for those with isolated bacteremia (adjusted odds ratio, 8.8), for premature versus term infants (AOR, 5.9), for infants who were ill appearing versus non-ill appearing (AOR, 3.9), and for infants with no fever versus those with fever (AOR, 2.4). No significant associations with 30-day adverse outcomes were seen in patients with a complex chronic condition, compared with those without a complex chronic condition (AOR, 2.0), nor in the those aged 29-60 days versus those younger than 29 days (15% vs. 14%, respectively; AOR 0.7).
“When looking at the most common scenario – a full-term infant without an ill appearance, and bacteremia as opposed to bacterial meningitis – 3 of these 219 infants, or 1.4%, had an adverse outcome,” said Dr. Pruitt, who cares for patients in the ED at Children’s of Alabama in Birmingham. “And there were no deaths.” He also reported that 12 infants with invasive bacterial infections were discharged from the index ED visit without antimicrobial treatment. All had bacteremia and none had an adverse outcome.
Dr. Pruitt acknowledged certain limitations of the study, including its retrospective design, that the outcomes were limited to 30 days, and the fact that the findings may not be generalizable to nontertiary settings. “Our findings have important implications for the care of infants with invasive bacterial infections,” he concluded. “In particular, the high rate of adverse outcomes for infants with bacterial meningitis can provide some context for clinicians in assessing the need for diagnostic evaluation for invasive bacterial infection and discussing testing and treatment with parents. Our findings may also help to inform inpatient management for hospitalized infants with invasive bacterial infections, as well as anticipatory guidance for parents, particularly around follow-up. Further prospective studies evaluating the long-term outcomes of infants with invasive bacterial infections are needed.”
The study was supported in part by a grant from the National Institutes of Health. Dr. Pruitt reported having no financial disclosures.
TORONTO – Among infants up to 60 days old with an invasive bacterial infection, adverse outcomes are associated with prematurity, ill appearance, and bacterial meningitis, a multicenter retrospective analysis found.
“Young infants are susceptible to serious bacterial infections, particularly when they’re less than 60 days of age,” Christopher Pruitt, MD, said at the annual Pediatric Academic Societies meeting. “Among these infants, bacteremia and bacterial meningitis, also referred to as invasive bacterial infections, are associated with higher rates of morbidity and mortality.”
The primary outcome measure was occurrence of an adverse clinical outcome within 30 days following the index ED visit. Adverse outcomes were defined as use of mechanical ventilation, vasoactive medications, any neurologic sequelae, and death. The researchers used a mixed-effects logistic regression model and retained covariates with a P value of less than .10. Covariates analyzed included age less than 28 days, prematurity, presence or absence of a complex chronic condition, presence of fever, ill appearance, bacterial meningitis, and concordant empiric antimicrobial therapy.
Of the 442 infants included in the final analysis, the majority (80%) had bacteremia, 14% had bacterial meningitis plus bacteremia, and 6% had bacterial meningitis only. “For purposes of this study, patients with bacterial meningitis with or without bacteremia were categorized as having bacterial meningitis,” Dr. Pruitt said. He and his associates found that 14.5% of infants had one or more adverse outcomes. Adverse outcomes occurred in 39% of infants with bacterial meningitis, compared with 8.2% of infants with isolated bacteremia. Need for mechanical ventilation, vasoactive medications, and neurologic disability also was more common among infants with bacterial meningitis than it was among children with isolated bacteremia. There were 10 deaths overall, which amounted to about 2% in both groups.
On multivariate analysis, the rate of adverse outcomes was significantly higher for patients with bacterial meningitis than it was for those with isolated bacteremia (adjusted odds ratio, 8.8), for premature versus term infants (AOR, 5.9), for infants who were ill appearing versus non-ill appearing (AOR, 3.9), and for infants with no fever versus those with fever (AOR, 2.4). No significant associations with 30-day adverse outcomes were seen in patients with a complex chronic condition, compared with those without a complex chronic condition (AOR, 2.0), nor in the those aged 29-60 days versus those younger than 29 days (15% vs. 14%, respectively; AOR 0.7).
“When looking at the most common scenario – a full-term infant without an ill appearance, and bacteremia as opposed to bacterial meningitis – 3 of these 219 infants, or 1.4%, had an adverse outcome,” said Dr. Pruitt, who cares for patients in the ED at Children’s of Alabama in Birmingham. “And there were no deaths.” He also reported that 12 infants with invasive bacterial infections were discharged from the index ED visit without antimicrobial treatment. All had bacteremia and none had an adverse outcome.
Dr. Pruitt acknowledged certain limitations of the study, including its retrospective design, that the outcomes were limited to 30 days, and the fact that the findings may not be generalizable to nontertiary settings. “Our findings have important implications for the care of infants with invasive bacterial infections,” he concluded. “In particular, the high rate of adverse outcomes for infants with bacterial meningitis can provide some context for clinicians in assessing the need for diagnostic evaluation for invasive bacterial infection and discussing testing and treatment with parents. Our findings may also help to inform inpatient management for hospitalized infants with invasive bacterial infections, as well as anticipatory guidance for parents, particularly around follow-up. Further prospective studies evaluating the long-term outcomes of infants with invasive bacterial infections are needed.”
The study was supported in part by a grant from the National Institutes of Health. Dr. Pruitt reported having no financial disclosures.
TORONTO – Among infants up to 60 days old with an invasive bacterial infection, adverse outcomes are associated with prematurity, ill appearance, and bacterial meningitis, a multicenter retrospective analysis found.
“Young infants are susceptible to serious bacterial infections, particularly when they’re less than 60 days of age,” Christopher Pruitt, MD, said at the annual Pediatric Academic Societies meeting. “Among these infants, bacteremia and bacterial meningitis, also referred to as invasive bacterial infections, are associated with higher rates of morbidity and mortality.”
The primary outcome measure was occurrence of an adverse clinical outcome within 30 days following the index ED visit. Adverse outcomes were defined as use of mechanical ventilation, vasoactive medications, any neurologic sequelae, and death. The researchers used a mixed-effects logistic regression model and retained covariates with a P value of less than .10. Covariates analyzed included age less than 28 days, prematurity, presence or absence of a complex chronic condition, presence of fever, ill appearance, bacterial meningitis, and concordant empiric antimicrobial therapy.
Of the 442 infants included in the final analysis, the majority (80%) had bacteremia, 14% had bacterial meningitis plus bacteremia, and 6% had bacterial meningitis only. “For purposes of this study, patients with bacterial meningitis with or without bacteremia were categorized as having bacterial meningitis,” Dr. Pruitt said. He and his associates found that 14.5% of infants had one or more adverse outcomes. Adverse outcomes occurred in 39% of infants with bacterial meningitis, compared with 8.2% of infants with isolated bacteremia. Need for mechanical ventilation, vasoactive medications, and neurologic disability also was more common among infants with bacterial meningitis than it was among children with isolated bacteremia. There were 10 deaths overall, which amounted to about 2% in both groups.
On multivariate analysis, the rate of adverse outcomes was significantly higher for patients with bacterial meningitis than it was for those with isolated bacteremia (adjusted odds ratio, 8.8), for premature versus term infants (AOR, 5.9), for infants who were ill appearing versus non-ill appearing (AOR, 3.9), and for infants with no fever versus those with fever (AOR, 2.4). No significant associations with 30-day adverse outcomes were seen in patients with a complex chronic condition, compared with those without a complex chronic condition (AOR, 2.0), nor in the those aged 29-60 days versus those younger than 29 days (15% vs. 14%, respectively; AOR 0.7).
“When looking at the most common scenario – a full-term infant without an ill appearance, and bacteremia as opposed to bacterial meningitis – 3 of these 219 infants, or 1.4%, had an adverse outcome,” said Dr. Pruitt, who cares for patients in the ED at Children’s of Alabama in Birmingham. “And there were no deaths.” He also reported that 12 infants with invasive bacterial infections were discharged from the index ED visit without antimicrobial treatment. All had bacteremia and none had an adverse outcome.
Dr. Pruitt acknowledged certain limitations of the study, including its retrospective design, that the outcomes were limited to 30 days, and the fact that the findings may not be generalizable to nontertiary settings. “Our findings have important implications for the care of infants with invasive bacterial infections,” he concluded. “In particular, the high rate of adverse outcomes for infants with bacterial meningitis can provide some context for clinicians in assessing the need for diagnostic evaluation for invasive bacterial infection and discussing testing and treatment with parents. Our findings may also help to inform inpatient management for hospitalized infants with invasive bacterial infections, as well as anticipatory guidance for parents, particularly around follow-up. Further prospective studies evaluating the long-term outcomes of infants with invasive bacterial infections are needed.”
The study was supported in part by a grant from the National Institutes of Health. Dr. Pruitt reported having no financial disclosures.
REPORTING FROM PAS 2018
Key clinical point:
Major finding: The rate of adverse outcomes was significantly higher for patients with bacterial meningitis versus those with isolated bacteremia (adjusted odds ratio, 8.8) and for premature versus term infants (AOR, 5.9).
Study details: A multicenter, retrospective review of 442 infants with invasive bacterial infections who were initially evaluated in the ED.
Disclosures: The study was supported in part by a grant from the National Institutes of Health. Dr. Pruitt reported having no financial disclosures.
Babies exposed to SSRIs in utero have decreased LV size
TORONTO – according to a small study presented at the Pediatric Academic Societies annual meeting.
“Given the frequency of SSRI use during pregnancy and continued conflicting results regarding cardiac effects, it is an important area of study,” senior author Sarah Haskell, DO, said in an interview. Her group at the University of Iowa in Coralville, which includes first author Deidra Ansah, MD, previously demonstrated reduced ventricular size and cardiac function in sertraline-exposed animal models.
Compared with unexposed newborns, SSRI-exposed infants had a 16% reduction in right ventricular (RV) diameter in diastole (P = .02) and a 22% reduction in left ventricular (LV) volume in systole (P = .02). They also had decreased LV lengths in diastole and systole (P = .045 and .004, respectively), but no impact was noted on cardiac function, as measured by shortening fraction.
“While cardiac function was appropriate on the initial echocardiogram, there were significant differences in cardiac dimensions,” said Dr. Haskell. “Whether these differences influence health and disease susceptibility requires further, longer-term studies.”
Her group plans to continue investigating the effects of SSRIs on cardiac development and also plans to study the offspring of women who are depressed but not on pharmacologic treatment to determine the effects of depression alone on cardiac size and function.
Dr. Haskell and her colleagues studied 21 term infants without and 20 term infants with exposure to in utero SSRIs who underwent standard echocardiograms including four-chamber and M-mode views within 48 hours of life. Exclusion criteria included prematurity, large or small for gestational age, any respiratory or cardiac support, and any major congenital malformations.
The mothers of exposed infants had higher depression scores compared with controls (P = .004), and had minimal to mild depression. Otherwise, they were similar in terms of age, weight, and likelihood of having chronic or gestational hypertension or diabetes. There also were no differences in maternal conditions or infant birth weight, body surface area or gestational age.
In the infants, no differences were seen in the occurrence of patent foramen ovale, patent ductus arteriosus, ventricular septal defect, or peripheral pulmonary artery stenosis.
This research was supported by the Department of Pediatric K12 Child Health Research Career Development Award, the Stead Family Department of Pediatrics at the University of Iowa, an NIH T32 grant, and the Children’s Miracle Network. The authors reported no financial disclosures.
TORONTO – according to a small study presented at the Pediatric Academic Societies annual meeting.
“Given the frequency of SSRI use during pregnancy and continued conflicting results regarding cardiac effects, it is an important area of study,” senior author Sarah Haskell, DO, said in an interview. Her group at the University of Iowa in Coralville, which includes first author Deidra Ansah, MD, previously demonstrated reduced ventricular size and cardiac function in sertraline-exposed animal models.
Compared with unexposed newborns, SSRI-exposed infants had a 16% reduction in right ventricular (RV) diameter in diastole (P = .02) and a 22% reduction in left ventricular (LV) volume in systole (P = .02). They also had decreased LV lengths in diastole and systole (P = .045 and .004, respectively), but no impact was noted on cardiac function, as measured by shortening fraction.
“While cardiac function was appropriate on the initial echocardiogram, there were significant differences in cardiac dimensions,” said Dr. Haskell. “Whether these differences influence health and disease susceptibility requires further, longer-term studies.”
Her group plans to continue investigating the effects of SSRIs on cardiac development and also plans to study the offspring of women who are depressed but not on pharmacologic treatment to determine the effects of depression alone on cardiac size and function.
Dr. Haskell and her colleagues studied 21 term infants without and 20 term infants with exposure to in utero SSRIs who underwent standard echocardiograms including four-chamber and M-mode views within 48 hours of life. Exclusion criteria included prematurity, large or small for gestational age, any respiratory or cardiac support, and any major congenital malformations.
The mothers of exposed infants had higher depression scores compared with controls (P = .004), and had minimal to mild depression. Otherwise, they were similar in terms of age, weight, and likelihood of having chronic or gestational hypertension or diabetes. There also were no differences in maternal conditions or infant birth weight, body surface area or gestational age.
In the infants, no differences were seen in the occurrence of patent foramen ovale, patent ductus arteriosus, ventricular septal defect, or peripheral pulmonary artery stenosis.
This research was supported by the Department of Pediatric K12 Child Health Research Career Development Award, the Stead Family Department of Pediatrics at the University of Iowa, an NIH T32 grant, and the Children’s Miracle Network. The authors reported no financial disclosures.
TORONTO – according to a small study presented at the Pediatric Academic Societies annual meeting.
“Given the frequency of SSRI use during pregnancy and continued conflicting results regarding cardiac effects, it is an important area of study,” senior author Sarah Haskell, DO, said in an interview. Her group at the University of Iowa in Coralville, which includes first author Deidra Ansah, MD, previously demonstrated reduced ventricular size and cardiac function in sertraline-exposed animal models.
Compared with unexposed newborns, SSRI-exposed infants had a 16% reduction in right ventricular (RV) diameter in diastole (P = .02) and a 22% reduction in left ventricular (LV) volume in systole (P = .02). They also had decreased LV lengths in diastole and systole (P = .045 and .004, respectively), but no impact was noted on cardiac function, as measured by shortening fraction.
“While cardiac function was appropriate on the initial echocardiogram, there were significant differences in cardiac dimensions,” said Dr. Haskell. “Whether these differences influence health and disease susceptibility requires further, longer-term studies.”
Her group plans to continue investigating the effects of SSRIs on cardiac development and also plans to study the offspring of women who are depressed but not on pharmacologic treatment to determine the effects of depression alone on cardiac size and function.
Dr. Haskell and her colleagues studied 21 term infants without and 20 term infants with exposure to in utero SSRIs who underwent standard echocardiograms including four-chamber and M-mode views within 48 hours of life. Exclusion criteria included prematurity, large or small for gestational age, any respiratory or cardiac support, and any major congenital malformations.
The mothers of exposed infants had higher depression scores compared with controls (P = .004), and had minimal to mild depression. Otherwise, they were similar in terms of age, weight, and likelihood of having chronic or gestational hypertension or diabetes. There also were no differences in maternal conditions or infant birth weight, body surface area or gestational age.
In the infants, no differences were seen in the occurrence of patent foramen ovale, patent ductus arteriosus, ventricular septal defect, or peripheral pulmonary artery stenosis.
This research was supported by the Department of Pediatric K12 Child Health Research Career Development Award, the Stead Family Department of Pediatrics at the University of Iowa, an NIH T32 grant, and the Children’s Miracle Network. The authors reported no financial disclosures.
AT PAS 2018
Key clinical point: Babies exposed to SSRIs in utero have smaller hearts compared with babies not exposed to SSRIs.
Major finding: Compared with unexposed newborns, SSRI-exposed infants had a 16% reduction in right ventricular diameter in diastole (P = .02) and a 22% reduction in left ventricular volume in systole (P = .02).
Study details: A study of 20 babies exposed to SSRIs in utero and 21 not exposed.
Disclosures: This research was supported by the Department of Pediatric K12 Child Health Research Career Development Award, the Stead Family Department of Pediatrics at the University of Iowa, an NIH T32 grant, and the Children’s Miracle Network. The authors reported no financial disclosures.
Fewer preterm deliveries, and perinatal mortality down
Fewer infants are being delivered early, and there has been a decline in neonatal mortality, according to a retrospective cohort study of more than 34 million singleton live births.
Researchers presented the results of a study in the May 14 online edition of JAMA Pediatrics that attempted to quantify changes in gestational age distribution and gestational age–specific perinatal mortality in the United States between 2007 and 2015.
However the proportion of births at a gestational age of 39-40 weeks increased from 54.5% to 60.2% in that same time period.
“The decreasing proportion of births at gestational ages of 34-36 and 37-38 weeks may be associated with changes in the timing of elective delivery, with hospital policies and quality initiatives effectively reducing unindicated deliveries before 39 completed weeks of gestation,” wrote Cande V. Ananth, PhD, of Columbia University, New York, and coauthors.
“Increased use of low-dose aspirin in women with ischemic placental disease may additionally have resulted in decreased need for indicated delivery before 39 weeks.”
At the same time, perinatal mortality rates decreased overall, from 9 per 1,000 births in 2007 to 8.6 per 1,000 births in 2015, but increased significantly in gestational ages 32-33 weeks (7%), 34-36 weeks (15%), and 37-38 weeks (23%) over that period. There was also a significant 31% increase in perinatal mortality at gestational age 42-44 weeks, but decreases at 20-27 weeks and 39-40 weeks.
Stillbirth rates also increased for gestational ages of 20-27 weeks, 28-31 weeks, 32-33 weeks, 34-36 weeks, 37-38 weeks, and 42-44 weeks.
Commenting on the changes in perinatal and neonatal mortality rates at gestational ages of 34-36 weeks and 37-38 weeks, the authors suggested this may have been the result of recommendations to postpone elective deliveries until 39 weeks.
“A possible reason for the increased mortality at a gestational age of 37-38 weeks could be that physicians may be more likely to defer to 39 weeks for delivery for women at moderately increased risk for adverse perinatal outcomes,” they wrote.
“We found that the decrease in neonatal mortality rates from 2007 to 2015 in the United States was largely associated with changes in the underlying gestational age distribution and less associated with changes in gestational age–specific mortality.”
The researchers reported that they had no conflicts of interest.
SOURCE: Ananth C et al. JAMA Pediatrics. 2018 May 14. doi: 10.1001/jamapediatrics.2018.0249.
Fewer infants are being delivered early, and there has been a decline in neonatal mortality, according to a retrospective cohort study of more than 34 million singleton live births.
Researchers presented the results of a study in the May 14 online edition of JAMA Pediatrics that attempted to quantify changes in gestational age distribution and gestational age–specific perinatal mortality in the United States between 2007 and 2015.
However the proportion of births at a gestational age of 39-40 weeks increased from 54.5% to 60.2% in that same time period.
“The decreasing proportion of births at gestational ages of 34-36 and 37-38 weeks may be associated with changes in the timing of elective delivery, with hospital policies and quality initiatives effectively reducing unindicated deliveries before 39 completed weeks of gestation,” wrote Cande V. Ananth, PhD, of Columbia University, New York, and coauthors.
“Increased use of low-dose aspirin in women with ischemic placental disease may additionally have resulted in decreased need for indicated delivery before 39 weeks.”
At the same time, perinatal mortality rates decreased overall, from 9 per 1,000 births in 2007 to 8.6 per 1,000 births in 2015, but increased significantly in gestational ages 32-33 weeks (7%), 34-36 weeks (15%), and 37-38 weeks (23%) over that period. There was also a significant 31% increase in perinatal mortality at gestational age 42-44 weeks, but decreases at 20-27 weeks and 39-40 weeks.
Stillbirth rates also increased for gestational ages of 20-27 weeks, 28-31 weeks, 32-33 weeks, 34-36 weeks, 37-38 weeks, and 42-44 weeks.
Commenting on the changes in perinatal and neonatal mortality rates at gestational ages of 34-36 weeks and 37-38 weeks, the authors suggested this may have been the result of recommendations to postpone elective deliveries until 39 weeks.
“A possible reason for the increased mortality at a gestational age of 37-38 weeks could be that physicians may be more likely to defer to 39 weeks for delivery for women at moderately increased risk for adverse perinatal outcomes,” they wrote.
“We found that the decrease in neonatal mortality rates from 2007 to 2015 in the United States was largely associated with changes in the underlying gestational age distribution and less associated with changes in gestational age–specific mortality.”
The researchers reported that they had no conflicts of interest.
SOURCE: Ananth C et al. JAMA Pediatrics. 2018 May 14. doi: 10.1001/jamapediatrics.2018.0249.
Fewer infants are being delivered early, and there has been a decline in neonatal mortality, according to a retrospective cohort study of more than 34 million singleton live births.
Researchers presented the results of a study in the May 14 online edition of JAMA Pediatrics that attempted to quantify changes in gestational age distribution and gestational age–specific perinatal mortality in the United States between 2007 and 2015.
However the proportion of births at a gestational age of 39-40 weeks increased from 54.5% to 60.2% in that same time period.
“The decreasing proportion of births at gestational ages of 34-36 and 37-38 weeks may be associated with changes in the timing of elective delivery, with hospital policies and quality initiatives effectively reducing unindicated deliveries before 39 completed weeks of gestation,” wrote Cande V. Ananth, PhD, of Columbia University, New York, and coauthors.
“Increased use of low-dose aspirin in women with ischemic placental disease may additionally have resulted in decreased need for indicated delivery before 39 weeks.”
At the same time, perinatal mortality rates decreased overall, from 9 per 1,000 births in 2007 to 8.6 per 1,000 births in 2015, but increased significantly in gestational ages 32-33 weeks (7%), 34-36 weeks (15%), and 37-38 weeks (23%) over that period. There was also a significant 31% increase in perinatal mortality at gestational age 42-44 weeks, but decreases at 20-27 weeks and 39-40 weeks.
Stillbirth rates also increased for gestational ages of 20-27 weeks, 28-31 weeks, 32-33 weeks, 34-36 weeks, 37-38 weeks, and 42-44 weeks.
Commenting on the changes in perinatal and neonatal mortality rates at gestational ages of 34-36 weeks and 37-38 weeks, the authors suggested this may have been the result of recommendations to postpone elective deliveries until 39 weeks.
“A possible reason for the increased mortality at a gestational age of 37-38 weeks could be that physicians may be more likely to defer to 39 weeks for delivery for women at moderately increased risk for adverse perinatal outcomes,” they wrote.
“We found that the decrease in neonatal mortality rates from 2007 to 2015 in the United States was largely associated with changes in the underlying gestational age distribution and less associated with changes in gestational age–specific mortality.”
The researchers reported that they had no conflicts of interest.
SOURCE: Ananth C et al. JAMA Pediatrics. 2018 May 14. doi: 10.1001/jamapediatrics.2018.0249.
FROM JAMA PEDIATRICS
Key clinical point: Preterm births and perinatal mortality decreased from 2007 to 2015.
Major finding: The proportion of births at 39-40 weeks increased from 54.5% to 60.2% between 2007 and 2015.
Study details: A retrospective cohort study of nearly 35 million singleton births.
Disclosures: The researchers reported that they had no conflicts of interest.
Source: Ananth C et al. JAMA Pediatrics. 2018 May 14. doi: 10.1001/jamapediatrics.2018.0249.
Responsive parenting intervention slows weight gain in infancy
TORONTO – Teaching parents of newborns to respond to eating and satiety cues in ways that promote self-regulation was associated with improvements in some weight outcomes at 3 years in a randomized clinical trial.
For the primary outcome of body mass index (BMI) z score at 3 years, a significant difference favoring the responsive parenting (RP) intervention was seen (–0.13 vs. 0.15 for controls; absolute difference, –0.28; P = .04). A longitudinal analysis examining the entire intervention period confirmed that the mean BMI group differences across seven study visits confirmed the effect of the RP intervention on BMI (P less than .001).
“We felt that the BMI z score and longitudinal growth analysis are probably the most sustained effects for an early-life intervention that have been recorded to date,” reported Ian M. Paul, MD, MSc, of Penn State University, Hershey. “While the differences between study groups were modest and not all achieved statistical significance, all favored the responsive-parenting intervention.”
Mean BMI percentile, a secondary outcome, was 47th for the RP group and 54th for controls, narrowly missing statistical significance (P = .07). Similarly, the percent of children deemed overweight at 3 years was 11.2% for the RP group and 19.8% for controls (P = .07), while 2.6% and 7.8%, respectively, were obese (P = .08).
No significant differences were seen in growth-related adverse events, such a weight-for-age less than the 5th percentile. The issue of “inducing” failure-to-thrive with a feeding intervention is a concern, said Dr. Paul, but there was no evidence for it in their study.
“One could question whether [the small differences seen between groups] are clinically significant, but if we look at how small differences have changed in the population over time and how those equate as far as longitudinal risk for cardiovascular outcomes and metabolic syndrome, etc., the small differences [we saw] might be important on a population level,” said Dr. Paul at the Pediatric Academic Societies meeting.
Study details
With upwards of one-quarter of U.S. children aged 2-5 years being overweight or obese, interventions to prevent rapid weight gain and reduce risk for overweight status in infancy are needed, noted Dr. Paul. Another reason to consider very early intervention, he added, is that infancy is a time of both “metabolic and behavioral plasticity.” However, most efforts to intervene early have, thus far, had limited success.
“Our responses to a baby crying are to feed that baby,” said Dr. Paul. This urge, along with others (such as “clear your plate”), evolved during times of food scarcity but persist now that we have inexpensive and palatable food, and promote rapid infant weight gain and increased obesity risk.
An alternative to those traditional parenting practices are responsive feeding and responsive parenting, he explained. “Responsive feeding and parenting requires prompt, developmentally appropriate responses to a child’s behaviors including hunger and satiety cues.”
In other studies, RP has been shown to foster cognitive, social, and emotional development. “The question we had was: Can responsive parenting reduce obesity risk?” he said.
The INSIGHT (Intervention Nurses Start Infants Growing on Healthy Trajectories) study is an ongoing, randomized clinical trial started in January 2012 comparing an RP intervention designed to prevent childhood obesity with a safety control, with the interventions matched on intensity and length.
Parent-child dyads were randomized 2 weeks after birth and were told that the purpose of the study was “to see if nurse visits to your home during your baby’s infancy can improve your ability to either respond to your child’s cues related to feeding and fussiness or improve your ability to provide a safe environment for your child and prevent injuries.”
A total of 279 primiparous mother-newborn dyads were studied. Most were white (89%) and non-Hispanic (94%), and the majority were married (75%). Mean prepregnancy BMI was 25.5 kg/m2.
“We chose first-time mothers because we thought they were more likely to listen to the parenting advice that we had to offer,” said Dr. Paul.
INSIGHT’s curriculum focused on RP in domains of infant feeding, sleep, interactive play, and emotion regulation. “We tried to promote self-regulation by setting limits but still being responsive in a variety of behavior domains,” Dr. Paul said. “So, for example…, for feeding we talked about exposure to healthy foods, shared feeding responsibility, for those that were bottle feeding we gave tips on size of bottle appropriate for the child and also not using bottle finishing practices. In the emotional and social regulation domain, we talked about alternatives to food to soothe, and emphasized embracing each child’s temperament and how to respond to different temperaments.”
Dr. Paul reported no conflicts of interest. INSIGHT is supported by National Institute of Diabetes and Digestive and Kidney Diseases research grants, with additional support from the Children’s Miracle Network at Penn State Children’s Hospital.
TORONTO – Teaching parents of newborns to respond to eating and satiety cues in ways that promote self-regulation was associated with improvements in some weight outcomes at 3 years in a randomized clinical trial.
For the primary outcome of body mass index (BMI) z score at 3 years, a significant difference favoring the responsive parenting (RP) intervention was seen (–0.13 vs. 0.15 for controls; absolute difference, –0.28; P = .04). A longitudinal analysis examining the entire intervention period confirmed that the mean BMI group differences across seven study visits confirmed the effect of the RP intervention on BMI (P less than .001).
“We felt that the BMI z score and longitudinal growth analysis are probably the most sustained effects for an early-life intervention that have been recorded to date,” reported Ian M. Paul, MD, MSc, of Penn State University, Hershey. “While the differences between study groups were modest and not all achieved statistical significance, all favored the responsive-parenting intervention.”
Mean BMI percentile, a secondary outcome, was 47th for the RP group and 54th for controls, narrowly missing statistical significance (P = .07). Similarly, the percent of children deemed overweight at 3 years was 11.2% for the RP group and 19.8% for controls (P = .07), while 2.6% and 7.8%, respectively, were obese (P = .08).
No significant differences were seen in growth-related adverse events, such a weight-for-age less than the 5th percentile. The issue of “inducing” failure-to-thrive with a feeding intervention is a concern, said Dr. Paul, but there was no evidence for it in their study.
“One could question whether [the small differences seen between groups] are clinically significant, but if we look at how small differences have changed in the population over time and how those equate as far as longitudinal risk for cardiovascular outcomes and metabolic syndrome, etc., the small differences [we saw] might be important on a population level,” said Dr. Paul at the Pediatric Academic Societies meeting.
Study details
With upwards of one-quarter of U.S. children aged 2-5 years being overweight or obese, interventions to prevent rapid weight gain and reduce risk for overweight status in infancy are needed, noted Dr. Paul. Another reason to consider very early intervention, he added, is that infancy is a time of both “metabolic and behavioral plasticity.” However, most efforts to intervene early have, thus far, had limited success.
“Our responses to a baby crying are to feed that baby,” said Dr. Paul. This urge, along with others (such as “clear your plate”), evolved during times of food scarcity but persist now that we have inexpensive and palatable food, and promote rapid infant weight gain and increased obesity risk.
An alternative to those traditional parenting practices are responsive feeding and responsive parenting, he explained. “Responsive feeding and parenting requires prompt, developmentally appropriate responses to a child’s behaviors including hunger and satiety cues.”
In other studies, RP has been shown to foster cognitive, social, and emotional development. “The question we had was: Can responsive parenting reduce obesity risk?” he said.
The INSIGHT (Intervention Nurses Start Infants Growing on Healthy Trajectories) study is an ongoing, randomized clinical trial started in January 2012 comparing an RP intervention designed to prevent childhood obesity with a safety control, with the interventions matched on intensity and length.
Parent-child dyads were randomized 2 weeks after birth and were told that the purpose of the study was “to see if nurse visits to your home during your baby’s infancy can improve your ability to either respond to your child’s cues related to feeding and fussiness or improve your ability to provide a safe environment for your child and prevent injuries.”
A total of 279 primiparous mother-newborn dyads were studied. Most were white (89%) and non-Hispanic (94%), and the majority were married (75%). Mean prepregnancy BMI was 25.5 kg/m2.
“We chose first-time mothers because we thought they were more likely to listen to the parenting advice that we had to offer,” said Dr. Paul.
INSIGHT’s curriculum focused on RP in domains of infant feeding, sleep, interactive play, and emotion regulation. “We tried to promote self-regulation by setting limits but still being responsive in a variety of behavior domains,” Dr. Paul said. “So, for example…, for feeding we talked about exposure to healthy foods, shared feeding responsibility, for those that were bottle feeding we gave tips on size of bottle appropriate for the child and also not using bottle finishing practices. In the emotional and social regulation domain, we talked about alternatives to food to soothe, and emphasized embracing each child’s temperament and how to respond to different temperaments.”
Dr. Paul reported no conflicts of interest. INSIGHT is supported by National Institute of Diabetes and Digestive and Kidney Diseases research grants, with additional support from the Children’s Miracle Network at Penn State Children’s Hospital.
TORONTO – Teaching parents of newborns to respond to eating and satiety cues in ways that promote self-regulation was associated with improvements in some weight outcomes at 3 years in a randomized clinical trial.
For the primary outcome of body mass index (BMI) z score at 3 years, a significant difference favoring the responsive parenting (RP) intervention was seen (–0.13 vs. 0.15 for controls; absolute difference, –0.28; P = .04). A longitudinal analysis examining the entire intervention period confirmed that the mean BMI group differences across seven study visits confirmed the effect of the RP intervention on BMI (P less than .001).
“We felt that the BMI z score and longitudinal growth analysis are probably the most sustained effects for an early-life intervention that have been recorded to date,” reported Ian M. Paul, MD, MSc, of Penn State University, Hershey. “While the differences between study groups were modest and not all achieved statistical significance, all favored the responsive-parenting intervention.”
Mean BMI percentile, a secondary outcome, was 47th for the RP group and 54th for controls, narrowly missing statistical significance (P = .07). Similarly, the percent of children deemed overweight at 3 years was 11.2% for the RP group and 19.8% for controls (P = .07), while 2.6% and 7.8%, respectively, were obese (P = .08).
No significant differences were seen in growth-related adverse events, such a weight-for-age less than the 5th percentile. The issue of “inducing” failure-to-thrive with a feeding intervention is a concern, said Dr. Paul, but there was no evidence for it in their study.
“One could question whether [the small differences seen between groups] are clinically significant, but if we look at how small differences have changed in the population over time and how those equate as far as longitudinal risk for cardiovascular outcomes and metabolic syndrome, etc., the small differences [we saw] might be important on a population level,” said Dr. Paul at the Pediatric Academic Societies meeting.
Study details
With upwards of one-quarter of U.S. children aged 2-5 years being overweight or obese, interventions to prevent rapid weight gain and reduce risk for overweight status in infancy are needed, noted Dr. Paul. Another reason to consider very early intervention, he added, is that infancy is a time of both “metabolic and behavioral plasticity.” However, most efforts to intervene early have, thus far, had limited success.
“Our responses to a baby crying are to feed that baby,” said Dr. Paul. This urge, along with others (such as “clear your plate”), evolved during times of food scarcity but persist now that we have inexpensive and palatable food, and promote rapid infant weight gain and increased obesity risk.
An alternative to those traditional parenting practices are responsive feeding and responsive parenting, he explained. “Responsive feeding and parenting requires prompt, developmentally appropriate responses to a child’s behaviors including hunger and satiety cues.”
In other studies, RP has been shown to foster cognitive, social, and emotional development. “The question we had was: Can responsive parenting reduce obesity risk?” he said.
The INSIGHT (Intervention Nurses Start Infants Growing on Healthy Trajectories) study is an ongoing, randomized clinical trial started in January 2012 comparing an RP intervention designed to prevent childhood obesity with a safety control, with the interventions matched on intensity and length.
Parent-child dyads were randomized 2 weeks after birth and were told that the purpose of the study was “to see if nurse visits to your home during your baby’s infancy can improve your ability to either respond to your child’s cues related to feeding and fussiness or improve your ability to provide a safe environment for your child and prevent injuries.”
A total of 279 primiparous mother-newborn dyads were studied. Most were white (89%) and non-Hispanic (94%), and the majority were married (75%). Mean prepregnancy BMI was 25.5 kg/m2.
“We chose first-time mothers because we thought they were more likely to listen to the parenting advice that we had to offer,” said Dr. Paul.
INSIGHT’s curriculum focused on RP in domains of infant feeding, sleep, interactive play, and emotion regulation. “We tried to promote self-regulation by setting limits but still being responsive in a variety of behavior domains,” Dr. Paul said. “So, for example…, for feeding we talked about exposure to healthy foods, shared feeding responsibility, for those that were bottle feeding we gave tips on size of bottle appropriate for the child and also not using bottle finishing practices. In the emotional and social regulation domain, we talked about alternatives to food to soothe, and emphasized embracing each child’s temperament and how to respond to different temperaments.”
Dr. Paul reported no conflicts of interest. INSIGHT is supported by National Institute of Diabetes and Digestive and Kidney Diseases research grants, with additional support from the Children’s Miracle Network at Penn State Children’s Hospital.
REPORTING FROM PAS 2018
Key clinical point:
Major finding: For the primary outcome of body mass index z score at 3 years, a significant difference favoring the responsive parenting intervention was seen (–0.13 vs. 0.15 for controls; absolute difference, –0.28; P = .04).
Study details: A randomized clinical trial including 279 mother-newborn dyads.
Disclosures: Dr. Paul reported no conflicts of interest. INSIGHT is supported by National Institute of Diabetes and Digestive and Kidney Diseases research grants, with additional support from the Children’s Miracle Network at Penn State Children’s Hospital.