Monday, April 27, 2026
NIH-funded clinical trial shows that the new approach could also decrease time in the hospital.
A National Institutes of Health (NIH)-funded clinical study shows that a symptom-based treatment for babies with neonatal opioid withdrawal syndrome (NOWS) — a highly prevalent condition wherein opioid exposure during pregnancy leads to withdrawal after birth — could speed up their recovery.
To treat babies with moderate to severe symptoms of NOWS, doctors often administer opioid medication, lowering the dose over time. Many doctors commonly use this scheduled dosing approach, however, the new study found that providing “as-needed” doses of opioid medications based on each baby’s signs of withdrawal helped them stop the medicine sooner and go home earlier.
“Scheduled opioid dosing, which includes a taper, is necessary for some infants with NOWS, however it may overtreat others,” said corresponding author Lori Devlin, D.O., a professor of pediatrics at the University of Louisville and Norton Children’s Neonatology. “The idea is that by matching treatment to disease severity, we can accelerate recovery and minimize exposure.”
Through a clinical trial, called Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW), Devlin and her colleagues compared a symptom-based approach to a traditional scheduled dosing approach.
In this study, 383 infants with moderate to severe NOWS who were cared for with the family-centered Eat, Sleep, Console (ESC) approach were split into two groups.
One group of 194 infants received scheduled opioids which were tapered after signs of withdrawal were well controlled. The other group of 189 infants received doses of opioid medication when their signs of withdrawal reached a prespecified threshold and only received additional doses if their withdrawal severity once again reached the threshold for treatment. Established guardrails prevented undertreatment for infants whose withdrawal did not improve with symptom-based opioid dosing.
The researchers recorded the length of time until each newborn was ready to go home. They found that babies receiving the symptom-based dosing were ready to go home two days earlier than babies receiving the scheduled dosing. The researchers also found that the symptom-based group stopped medication sooner.
The researchers did not find that symptom-based dosing conferred the same benefits to infants with NOWS who were initially cared for through the traditional, healthcare provider-centric Finnegan approach instead of ESC.
Since the trial, several hospitals involved in the study have adopted the symptom-based strategy — and the authors believe their results may inform broader adoption.
“The opioid epidemic is still a huge problem, but this is a simple and powerful way we can get these babies ready to go home faster. This is best for their family and for their own development,” said study co-author Augusto Schmidt, M.D., Ph.D., a program officer at NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
The trial is part of the Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative® and was supported by NICHD grants U24HD107621, UG1HD107580, UG1HD107616, UG1HD107627, UG1HD107628, UG1HD107631, UG1HD107649, UG1HD107650, and UG1HD107653.
NIH HEAL Initiative and Helping to End Addiction Long-term are registered service marks of the U.S. Department of Health and Human Services.
About the National Institutes of Health (NIH): NIH, the nation’s medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.
NIH…Turning Discovery Into Health®
Reference
Lori A. Devlin et al. Symptom-Based Dosing for Neonatal Opioid Withdrawal: Outcomes from the OPTimize NOW Study. The Journal of the American Medical Association. 2026. DOI: 10.1001/jama.2026.5782