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.

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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

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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

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

ECHO

Environmental Influences on Child Health Outcomes

ESC

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