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.