Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial

Author(s): Lori A. Devlin, Zhuopei Hu, Stephanie L. Merhar, et al.

Why was this study conducted?

This secondary analysis of infants enrolled in the Eating, Sleeping and Consoling for Neonatal Opioid Withdrawal (ESC-NOW) trial, which was conducted at 26 hospitals across the U.S., focused specifically on infants who received opioid treatment for NOWS after birth. The analysis was conducted to identify whether the ESC care approach decreased total postnatal opioid exposure when compared to sites’ usual care practices, which included the use of the Finnegan Neonatal Abstinence Scoring Tool (FNAST).

What was done?

The authors analyzed data from 463 infants who were enrolled in the ESC-NOW trial. All infants were born at 36 weeks’ gestation or later and received pharmacologic treatment for NOWS after birth. Three hundred and twenty infants were assessed and managed for NOWS with usual care, and 143 infants were assessed and managed with the ESC care approach.

What was found?

In this subgroup analysis, the authors found that total postnatal opioid exposure was substantially less for infants who were assessed and managed with the ESC care approach when compared to usual care.

The absolute mean difference in total opioid exposure was 4.1 morphine milligram equivalents (MME)/kilogram (kg) less for infants in the ESC group when compared to the usual care group (4.8 vs. 8.9 MME/kg respectively). Infants in the ESC group also received an average of 48.7 fewer opioid doses than those in the usual care group (67.5 vs. 116.1 doses respectively). In addition, the mean length of opioid treatment was 6.3 days less in the ESC group than in the usual care group (11.8 vs. 18.1 days respectively), and the mean length of hospital stay was 6.2 days less in the ESC group than in the usual care group.

The authors also found that the mean time from birth to the initiation of pharmacologic care was 22.4 hours longer in the ESC group than in the usual care group (75.4 vs. 53.0 hours respectively), but there was no difference in the mean peak opioid dose between groups.

What do the results mean?

Infants who were assessed and managed with the ESC care approach received less opioid medication for the treatment of NOWS after birth when compared to those who were assessed and managed with usual care, including the FNAST.
Infants assessed and managed with the ESC care approach also had fewer days of opioid treatment and a shorter length of hospital stay when compared to usual care.
The time from birth to the initiation of opioid treatment was longer in infants who were assessed and managed with the ESC care approach, but there was no difference in the peak dose of opioid medication, which suggests that the ESC care approach aptly assesses and supports acute opioid withdrawal.

Who sponsored this study?

This clinical trial is a collaboration between the NIH Environmental influences on Child Health Outcomes (ECHO) Program and the NIH’s Eunice Kennedy Shriver Institute of Child Health and Human Development (NICHD), funded through the NIH Helping to End Addiction Long-term® Initiative (HEAL).

Where can I learn more?

Access the full journal article, titled “Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial,” in JAMA Pediatrics.

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Download this summary

Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial

Read Related Research Summaries

“Eat, Sleep, Console” approach shown to be more effective in caring for newborns with neonatal opioid withdrawal syndrome

Authors: Leslie Young, Lori Devlin, Stephanie Merhar, et al.

How does prenatal opioid exposure affect child outcomes?

Author(s): Elisabeth Conradt, Sheila Crowell and Barry Lester

Understanding characteristics associated with opioid use during pregnancy

Authors: Ruby H.N. Nguyen, Monica McGrath, et al.

Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome

Author(s): Stephanie Merhar, Songthip Ounpraseuth, Lori Devlin, et al.

Site-Level Variation in the Characteristics and Care of Infants with Neonatal Opioid Withdrawal

Author(s): Leslie Young, Zhuopei Hu, Robert Annett, et al.

The ACT NOW Clinical Practice Survey: Gaps in the Care of Infants With Neonatal Opioid Withdrawal Syndrome

Author(s): Jessica Snowden, Akshatha, Robert Annett, et al.

New Collaborative ECHO Research Demonstrates Effectiveness of “Eat, Sleep, Console” Approach in Caring for Newborns with Neonatal Opioid Withdrawal Syndrome

Posted on April 30, 2023May 1, 2023 by Jodi Snare

A collaborative effort between the NIH’s Eunice Kennedy Shriver Institute of Child Health and Human Development (NICHD) Neonatal Research Network and the Environmental influences on Child Health Outcomes (ECHO) Program’s Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN) found that the “Eat, Sleep, Console” (ESC) care approach is more effective for the treatment of newborns with neonatal opioid withdrawal syndrome (NOWS) than usual approaches to care. This research was led by ISPCTN investigators Leslie Young, MD of the University of Vermont; and Lori Devlin, DO, MHA, MS of the University of Louisville School of Medicine, Department of Pediatrics; along with Stephanie Merhar, MD, MS of Cincinnati Children’s Hospital and the NICHD Neonatal Research Network.

ESC prioritizes nonpharmacologic care, including holding, swaddling, and rocking in low-stimulus environments, as first-line treatment for neonatal opioid withdrawal symptoms. This research, funded through the NIH Helping to End Addiction Long-term^® Initiative (HEAL), showed that infants cared for with ESC were medically ready for discharge after an average of 8.2 days, whereas infants cared for with usual approaches were medically ready for discharge after 14.9 days. That means that babies were, on average, able to go home 6.7 days sooner. Newborns cared for with ESC were also 63% less likely to receive medication as part of their treatment. Safety outcomes at three months of age were similar in both groups. This research, titled “Eat, sleep, console approach versus usual care for neonatal opioid withdrawal,” is published in the New England Journal of Medicine.

“The study included rural and medically underserved communities that have been hard hit by the opioid crisis,” said Matthew W. Gillman, MD, director of the ECHO program. “These findings promise to improve outcomes and address the long-term needs of opioid-exposed infants and their families.”

Newborns exposed to opioids before birth may develop symptoms of NOWS, including tremors, excessive crying and irritability, and problems with sleeping and feeding. In the United States, at least one newborn is diagnosed with NOWS every 24 minutes. There has not previously been strong evidence to support a standard approach to the care of babies with NOWS, and medical care for these babies has varied widely across hospitals.

Hospitals often use the Finnegan Neonatal Abstinence Scoring Tool (FNAST) to assess newborns with NOWS. The FNAST is an extensive scoring system that assesses signs of withdrawal in more than 20 areas. However, concerns have been raised about its subjectivity and overestimation of the need for opioid medication. The ESC care approach, developed about eight years ago, assesses an infant’s ability to eat, sleep, and be consoled without the introduction of medications. This approach keeps mother and baby together, empowering families to play a larger role in the care of their infants.

The study examined the hospital outcomes of a diverse group of 1,305 opioid-exposed infants from 26 hospitals across the U.S. that were randomized to transition from FNAST-based care to the ESC care approach at different times. These findings are based on three-month outcomes, and a two-year follow-up study of a subset of the infants is ongoing. This follow-up is critical to further inform the safety of the ESC care approach.

This study is part of the Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Collaborative.

Learn more about this clinical trial and the NIH Helping to End Addiction Long-term^® Initiative on the NIH HEAL Initiative^® website.

Read the research summary.

“Eat, Sleep, Console” approach shown to be more effective in caring for newborns with neonatal opioid withdrawal syndrome

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“Eat, Sleep, Console” approach shown to be more effective in caring for newborns with neonatal opioid withdrawal syndrome

Author(s): Leslie Young, Lori Devlin, Stephanie Merhar, et al.

Who sponsored this study?

This clinical trial is a collaboration between the National Institutes of Health (NIH) Environmental influences on Child Health Outcomes (ECHO) Program and the NIH’s Eunice Kennedy Shriver Institute of Child Health and Human Development (NICHD), funded through the NIH Helping to End Addiction Long-term® Initiative (HEAL).

What were the study results?

Researchers found that the “Eat, Sleep, Console” (ESC) care approach is more effective for the treatment of infants with neonatal opioid withdrawal syndrome (NOWS) than usual approaches to care. ESC focuses on care without the use of medications, and includes holding, swaddling, and rocking the baby in a quiet, calm environment.

In this clinical trial, infants cared for with ESC were medically ready for discharge after an average of 8.2 days, whereas infants cared for with usual approaches were medically ready for discharge after 14.9 days. That means that babies were, on average, able to go home 6.7 days sooner. Newborns cared for with ESC were also 63% less likely to receive medication as part of their treatment (19.5% in the ESC group received opioid therapy, compared to 52% in the Finnegan Neonatal Abstinence Scoring Tool [FNAST] group). Safety outcomes at three months of age were similar between both groups.

What was the study's impact?

Newborns exposed to opioids before birth may develop symptoms of NOWS. These symptoms may include tremors, excessive crying and irritability, and problems with sleeping and feeding. In the United States, at least one newborn is diagnosed with NOWS every 24 minutes. There has not previously been strong evidence to support a standard approach to the care of babies with NOWS, and medical care for these babies has varied widely across hospitals.

This study gives hospitals an evidence-based approach to care for babies with NOWS. Compared with usual care using traditional scoring approaches, the ESC care approach substantially shortens the time infants spend in the hospital. The ESC approach has also been shown as safe as usual care approaches after discharge through early infancy.

Why was this study needed?

Hospitals have different approaches for caring for these babies. They often use FNAST to assess newborns with NOWS. The FNAST is an extensive scoring system that assesses signs of withdrawal in more than 20 areas. Concerns have been raised about its subjectivity and overestimation of the need for opioid medication.

The ESC care approach was developed about eight years ago and is growing in popularity in some nurseries, but this method had not previously been rigorously tested. ESC assessments are centered on an infant’s ability to eat, sleep and be consoled without the introduction of medications, and this approach keeps mother and baby together, empowering families to play a larger role in the care of their infants. However, the widespread adoption of ESC without solid evidence of its effectiveness and safety has raised concerns about potentially undertreating infants or discharging them too early. This study tested the extent to which ESC might be a better way to care for babies with NOWS.

Who was involved?

The study examined the hospital outcomes of a diverse group of 1,305 opioid-exposed infants from 26 hospitals across the U.S. The study is part of the Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Collaborative, which brings together two existing pediatric research networks: the NICHD Neonatal Research Network and the ECHO Program’s Institutional Development Award (IDeA) States Pediatric Clinical Trials Network (ISPCTN).

What happened during the study?

The researchers randomized 26 hospitals to transition from FNAST-based care to the ESC care approach at different times. They then evaluated each method based on how soon infants were ready to leave the hospital and whether infants were treated with opioid medication to manage their symptoms.

Footnote: Results reported here are for a single study. Other or future studies may provide new information or different results. You should not make changes to your healthcare without first consulting your healthcare professional.

What happens next?

The researchers will continue to follow up with a subset of the participating infants for two more years to see if the ESC approach has any effect on infant and family well-being.

Where can I learn more?

Access the full journal article, titled “Eat, sleep, console approach versus usual care for neonatal opioid withdrawal,” in the New England Journal of Medicine.

Learn more about this clinical trial and the NIH Helping to End Addiction Long-term^® Initiative on the NIH HEAL Initiative^® website.

The content is the responsibility of the authors and does not necessarily represent the official views of the NIH.

Access the associated article.

Published: April 30, 2023

Download this summary

“Eat, Sleep, Console” approach shown to be more effective in caring for newborns with neonatal opioid withdrawal syndrome

Read Related Research Summaries

How does prenatal opioid exposure affect child outcomes?

Author(s): Elisabeth Conradt, Sheila Crowell and Barry Lester

Understanding characteristics associated with opioid use during pregnancy

Authors: Ruby H.N. Nguyen, Monica McGrath, et al.

Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome

Author(s): Stephanie Merhar, Songthip Ounpraseuth, Lori Devlin, et al.

Site-Level Variation in the Characteristics and Care of Infants with Neonatal Opioid Withdrawal

Author(s): Leslie Young, Zhuopei Hu, Robert Annett, et al.

The ACT NOW Clinical Practice Survey: Gaps in the Care of Infants With Neonatal Opioid Withdrawal Syndrome

Author(s): Jessica Snowden, Akshatha, Robert Annett, et al.

The Influence of Opioid Use Disorder Medications During Pregnancy on the Severity of Neonatal Opioid Withdrawal Syndrome

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The Influence of Mediators on the Relationship Between Antenatal Opioid Agonist Exposure and the Severity of Neonatal Opioid Withdrawal Syndrome

Author(s): Lori A. Devlin, Zhuopei Hu, Songthip Ounpraseuth, Alan E. Simon, Robert D. Annett, Abhik Das, Janell F. Fuller, Rosemary D. Higgins, Stephanie L. Merhar, P. Brian Smith, Margaret M. Crawford, Lesley E. Cottrell, Adam J. Czynski, Sarah Newman, David A. Paul, Pablo J. Sánchez, Erin O. Semmens, M. Cody Smith, Bonny L. Whalen, Jessica N. Snowden, Leslie W. Young

Why was this study conducted?

Opioid use disorder is a treatable disease that can be managed with medicine for opioid use disorder (MOUD). This type of treatment is recommended for pregnant individuals by healthcare professionals to improve pregnancy and newborn outcomes.

Babies who were exposed to opioids during pregnancy may develop signs of neonatal opioid withdrawal syndrome (NOWS), including tremors; excessive crying and irritability; and problems with sleeping and feeding. This study looked at how MOUD use during pregnancy influenced the severity of NOWS symptoms.

What was done?

Data were collected from the medical records’ of 1294 opioid-exposed infants born at or cared for in 30 U.S. hospitals between July 2016 and June 2017. There were 859 infants exposed to MOUD (methadone or buprenorphine) and 435 infants exposed to opioids other than MOUD. We looked to see if infants needed medication to treat NOWS and how long they stayed in the hospital.

What was found?

The results suggest that exposure to MOUD (buprenorphine or methadone) during pregnancy increased the severity of NOWS. Infants exposed to MOUD were two times more likely to need an opioid medication to treat withdrawal. They also remained in the hospital 1.7 days longer than infants not exposed to MOUD. Some factors that reduced the severity of NOWS in infants treated with MOUD were adequate prenatal care, exposure to a single type of opioid, and not being exposed to other mood-changing drugs simultaneously. These factors also decreased the likelihood that infant would need opioid medicine to treat their NOWS symptoms and shortened their hospital stay. Infants exposed to buprenorphine instead of methadone had a shorter length of hospital stay and needed less treatment with opioid medication.

What do the results mean?

Medical experts recommend that pregnant women with an opioid use disorder use MOUD for healthier pregnancies. MOUD can reduce the chances of pregnancy loss, premature birth, infection, and poor growth of the infant. However, using MOUD may be related to increases in the severity of NOWS. Learning more about how MOUD affects the severity of NOWS can help doctors improve the health of mothers using MOUD and their babies. These results also suggest that adequate prenatal care can help improve pregnancy and birth outcomes, and highlight the importance of identifying barriers to receiving sufficient prenatal care as an opportunity to improve infant outcomes.

Who sponsored the study?

This research was supported by the Environmental Influences on Child Health Outcomes Program, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Center for Advancing Translational Sciences, and the National Institutes of Health.

Appreciation:

You may learn more about this publication here: https://link.springer.com/article/10.1007/s10995-022-03521-3

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published: March 11, 2023

Download this summary

The Influence of Mediators on the Relationship Between Antenatal Opioid Agonist Exposure and the Severity of Neonatal Opioid Withdrawal Syndrome

Read Related Research Summaries

“Eat, Sleep, Console” approach shown to be more effective in caring for newborns with neonatal opioid withdrawal syndrome

Author(s): Leslie Young, Lori Devlin, Stephanie Merhar, et al.

How does prenatal opioid exposure affect child outcomes?

Author(s): Elisabeth Conradt, Sheila Crowell and Barry Lester

Understanding characteristics associated with opioid use during pregnancy

Authors: Ruby H.N. Nguyen, Monica McGrath, et al.

Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome

Author(s): Stephanie Merhar, Songthip Ounpraseuth, Lori Devlin, et al.

Site-Level Variation in the Characteristics and Care of Infants with Neonatal Opioid Withdrawal

Author(s): Leslie Young, Zhuopei Hu, Robert Annett, et al.

The ACT NOW Clinical Practice Survey: Gaps in the Care of Infants With Neonatal Opioid Withdrawal Syndrome

Author(s): Jessica Snowden, Akshatha, Robert Annett, et al.

ECHO Study Examines Characteristics Associated with Opioid Use During Pregnancy

Posted on November 14, 2022March 31, 2025 by Jodi Snare

Collaborative ECHO research led by Ruby Nguyen, PhD of the University of Minnesota and Monica McGrath, ScD of Johns Hopkins University Bloomberg School of Public Health, described characteristics that were associated with opioid using during pregnancy. The study included over 20,000 pregnant participants from across the United States and found that the majority of individuals who used opioids during pregnancy were non-Hispanic White and college educated. The researchers also found that opioid use was more common among people who used tobacco or illegal drugs and those who had a history of depression or anxiety. This research, titled “Characteristics of Individuals in the U.S. who Used Opioids during Pregnancy,” is published in the Journal of Women’s Health.

Opioids are a class of drugs commonly used as prescription pain relievers that can cause dependence or addiction. Opioid use has disproportionally impacted pregnant women and their fetuses and previous studies of opioid use during pregnancy have been limited in size and scope. The stigmatization of this population has also affected the collection of data on maternal opioid use during pregnancy. This study utilized a large, geographically diverse group of pregnant participants from 32 ECHO cohorts across the U.S. to investigate rare exposures and factors that may affect an individual’s risk for opioid use during pregnancy.

During this study, the researchers analyzed data from pregnant participants who were enrolled in ECHO cohorts between 1991 and 2021. They used medical records, laboratory tests, and self-reported information to assess opioid use and potentially related factors. Of the 21,905 pregnancies evaluated, only 591 (2.8%) involved opioid use. The majority of opioid use during pregnancy originated from a prescription.

“This was among the largest observational studies of opioid use in pregnancy, and the diverse sample of pregnant women better represents the U.S. population than previous studies,” said Dr. Nguyen. “These findings will help to inform further research on screening tools for opioid use during pregnancy, and the finding that most opioid use originates from prescriptions reinforces the need to better monitor the amount of circulating prescription drugs, particularly in pregnant women.”

Further research is needed to understand the factors that contribute to the use of multiple substances during pregnancy and the interrelationship between substance use and depression or anxiety. The results of this study can contribute to the development of screening tools and procedures for identifying individuals who are potentially at-risk for opioid use during pregnancy.

Read the research summary.

ECHO Study Identifies Depression, Anxiety, and Other Drug Use as Risk Factors for Opioid Use During Pregnancy

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ECHO Study Identifies Depression, Anxiety, and Other Drug Use as Risk Factors for Opioid Use During Pregnancy

Authors: Ruby H.N. Nguyen, Monica McGrath, et al.

Who sponsored this study?

This research was supported by the Environmental influences on Child Health Outcomes (ECHO) Program, Office of The Director, National Institutes of Health.

What were the study results?

Most of the participants who used opioids were non-Hispanic White and had at least some college education. Opioid use was more common among people who used tobacco or illegal drugs, and those with a history of depression or anxiety. Additionally, opioid use during pregnancy in this study was rare—only 2.8% of participants used opioids during pregnancy, and the majority of opioid use originated from a prescription.

Footnote: Results reported here are for a single study. Other or future studies may provide new information or different results. You should not make changes to your health without first consulting your healthcare professional.

What was the study's impact?

This is among the largest observational studies of opioid use during pregnancy thus far, and the diverse sample of pregnant participants is more representative of the U.S. population than previous studies. Results from this study strengthened evidence about the co-occurrence of opioid use in pregnancy with depression and use of multiple substances (such as tobacco and illegal drugs). These findings will help to inform further research on screening tools for opioid use during pregnancy. Additionally, the finding that most opioid use originated from prescriptions reinforces the need to reduce the amount of circulating prescription drugs and to better monitor over-prescription of opioids to pregnant women and provide them with alternative treatment solutions for pain management and opioid dependency.

Why was this study needed?

Opioids are a class of drugs used as prescription pain relievers that can cause dependence or addiction. The opioid crisis has disproportionately affected women, and use of these drugs can have detrimental effects on women of reproductive ages and on developing fetuses. Previous studies of opioid use during pregnancy have been limited to individuals in specific geographic locations or those with specific types of insurance. The stigmatization of this population has also complicated the collection of data on maternal opioid use during pregnancy. Using a large sample size, this study examined opioid use in a diverse population of pregnant women across the United States to investigate rare exposures – such as polysubstance use - and characteristics associated with opioid use during pregnancy.

Who was involved?

This study included over 20,000 pregnant participants from 32 ECHO cohorts across the U.S., creating a large and geographically diverse sample.

What happened during the study?

The researchers gathered data from pregnant women who were already participants in ECHO cohorts between 1991 and 2021. Medical records, laboratory tests, and self-reports were used to assess opioid use and potentially related factors, such as demographics, use of other substances, and history of anxiety or depression.

What happens next?

This study shows that further research is needed on the factors that may lead to use of multiple substances during pregnancy and the association between substance use and depression. This research can help inform the development of screening tools and procedures for identifying individuals who are potentially at risk for opioid use during pregnancy.

Where can I learn more?

Access the full journal article, titled “Characteristics of Individuals in the U.S. who Used Opioids during Pregnancy,” in the Journal of Women’s Health.

The content is the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Published November 9, 2022

Access the associated article.

Download this summary

ECHO Study Identifies Depression, Anxiety, and Other Drug Use as Risk Factors for Opioid Use During Pregnancy

Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome

<< Back to Research Summaries

Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome

Author(s): Stephanie Merhar, Songthip Ounpraseuth, Lori Devlin, et al.

What was done?

We reviewed medical records from 30 U.S. hospitals. There were 180 babies with NOWS treated with morphine (M) and a secondary drug [phenobarbital (P) or clonidine (C)]. We compared the two groups (M + P and M + C) and calculated the number of days spent in the hospital and the number of days they received morphine.

What was found?

Babies in the M + P group had fewer days of morphine treatment compared to babies in the M + C group. They also spent fewer days in the hospital than the M + C group. However, babies in the M + P group were more likely to continue taking phenobarbital at home.

What do the results mean?

In this study, babies treated with M + P had shorter hospital stays, and in some cases, fewer days of morphine treatment. But, some studies show that long-term use of phenobarbital could cause problems with the development of the nervous system. More research is needed on the benefits and risks of using this drug to treat NOWS symptoms.

Why was this study conducted?

Babies exposed to opioids (e.g., morphine, methadone, etc.) in the womb may have drug withdrawal symptoms called neonatal opioid withdrawal syndrome (NOWS) after birth. Some are given medicine for their symptoms. If the medicine doesn’t work, doctors may add other (secondary) medicine to the treatment. This study looked at two secondary drugs used most often to see if one was better than the other in NOWS treatment.

Appreciation:

We deeply appreciate the doctors, nurses, and hospitals that participated in the study and helped identify and extract information from the required medical records. Their enthusiastic collaboration made this study possible. The authors thank the Environmental Influences on Child Health Outcomes Program, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Center for Advancing Translational Sciences, and the National Institutes of Health for supporting this research.

Access the full journal article, titled "Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome," published in Pediatrics.

Published March, 2021

The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

Download this summary

Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome

Resources

Centers for Disease Control and Prevention (CDC)

About Opioid Use During Pregnancy

Related Research Summaries

Site-Level Variation in the Characteristics and Care of Infants with Neonatal Opioid Withdrawal

Author(s): Leslie Young, Zhuopei Hu, Robert Annett, et al.

The ACT NOW Clinical Practice Survey: Gaps in the Care of Infants With Neonatal Opioid Withdrawal Syndrome

Author(s): Jessica Snowden, Akshatha, Robert Annett, et al

How does prenatal opioid exposure affect child outcomes?

Author(s): Elisabeth Conradt, Sheila Crowell, Barry Lester

ECHO ACT NOW Current Experience Manuscript Published in Pediatrics

Posted on February 2, 2021June 7, 2023 by Jodi Snare

In December, the ECHO IDeA States Pediatric Clinical Trials Network (ISPCTN) published its first ACT NOW Current Experience manuscript, “Site-Level Variation in the Characteristics and Care of Infants with Neonatal Opioid Withdrawal,” in Pediatrics.

The ACT NOW (Advancing Clinical Trials in Neonatal Opioid Withdrawal) Current Experience Study is designed to describe variation in the care of infants with neonatal opioid withdrawal syndrome (NOWS). The data collected were used to inform two of the ACT NOW clinical trials which are currently enrolling and will shape policies, programs, and practices in the care of infants with NOWS.

This cross-sectional study of 1,377 infants with evidence of opioid exposure at 30 participating hospitals nationwide described variation in maternal-infant characteristics, infant management, and outcomes for infants with NOWS.

The study found that sites varied widely in the proportion of infants whose mothers received adequate prenatal care, medication-assisted treatment, and prenatal counseling. Sites also varied in the proportion of infants with toxicology screening and proportion of infants receiving pharmacologic therapy, secondary medications, and non-pharmacologic interventions, including fortified feeds and maternal breast milk. The mean length of stay varied across sites (from two to 29 days), as did the proportion of infants discharged with their parents.

The study concluded that the wide variation in characteristics and treatment makes it unlikely that all infants are receiving efficient and effective care for NOWS. The research suggests that this variation should be considered in future clinical trial development, practice implementation, and policy development.

“Understanding the current landscape of NOWS is critical for future research and the development of programs, policies, and practices to provide better care for these infants,” said Leslie Young, MD, of the University of Vermont. “The degree of variation among infants with NOWS observed in this study shows a significant opportunity to improve the care they receive.”

Also available is a commentary associated with the article, emphasizing the importance of ISPCTN’s work for the field.

Establishing a Standard of Care for Babies Born Dependent on Opioids

Posted on July 22, 2020June 7, 2023 by Jodi Snare

Lead Investigators: Leslie Young, University of Vermont, Lori Devlin, University of Louisville, Stephanie Merhar, University of Cincinnati

As the opioid epidemic continues to affect families across the United States, opioid exposure in the womb has attracted more attention. When a woman uses opioids while she is pregnant, her newborn baby can have symptoms of withdrawal such as intense fussiness, inability to eat well, and poor sleep. Neonatal Opioid Withdrawal Syndrome, or NOWS, has increased five-fold over the last decade, but evidence as to the best approach for assessing and treating these infants is lacking.

That’s why ECHO—in partnership with the NIH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)—is launching the Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) initiative. One intervention trial slated to begin in late summer 2020 is Eating, Sleeping, and Consoling for Neonatal Opioid Withdrawal (ESC-NOW). In this study, researchers will test the effectiveness of ESC, a new method that nurseries can adopt for assessing and treating infants with NOWS. Comparing ESC to the usual care NOWS babies receive, they’ll evaluate how the ESC approach affects the short term—being ready for discharge from the hospital–as well as longer-term: how this approach affects family and infant well-being, as well as how well the baby’s brain is developing, during the first 2 years of life.

The ESC approach engages parents and other primary caregivers in the treatment of NOWS. It emphasizes tactics like holding, swaddling, and rocking in low stimulus environments, thus potentially lowering the need for medication.

Up to 3,000 infants and their primary caregivers will be included in this clinical trial across 26 sites in the United States. By filling gaps in our knowledge of how to take care of these babies, the results of this study may very well set a standard for improving the care of infants with NOWS.

ESC-NOW is one of several ACT NOW studies funded through the National Institutes of Health Helping to End Addiction Long-term (HEAL) Initiative.

ECHO Researchers Identify Gaps in Prenatal Opioid Exposure Research

Posted on August 28, 2019June 7, 2023 by Jodi Snare

This week, Pediatrics published results from ECHO researcher Elisabeth Conradt and her team’s efforts to learn more about prenatal opioid exposure and its effects on child development. Conradt and her team reviewed 52 publications to summarize what is known and make suggestions on how to expand knowledge in this area. The resulting article includes perspectives on how the ECHO Program can help learn more about this important topic.

“The number one question mothers, fathers, and clinicians have when they see that a mother is using opioids while pregnant is ‘how will this opioid exposure affect the child’s health?’ We cannot answer that question right now with the existing data,” Conradt said.

The team analyzed existing publications on three age groups: birth, infancy, and 2 years and older. Because of inconsistent and limited data, Condradt’s team was not able to understand a connection between prenatal opioid exposure and how children’s minds develop throughout life. However, they predict that the effects of the exposure at birth and infancy are small and subtle, but may increase as children age and have more demands on their attention at home and school.

Current studies were limited because of small sample sizes and difficulty controlling for confounding factors such as where a person lives or how much money their family makes.

Moving forward, the team will use ECHO data to test how prenatal opioid exposure affects learning, understanding, behavior, and attention span in middle childhood. They will also consider other possible factors such as poverty. Conradt noted that the team will also look at whether newborns who have neonatal opioid withdrawal syndrome (NOWS) have worse effects compared with newborns exposed to opioids who do not have NAS/NOWS.

Read the study summary and full media release.