KENTUCKY — The research indicated that 65% of babies treated with the symptom-based approach combined with the Eat, Sleep, Console model did not require scheduled opioid medications or gradual weaning. The 2026 JAMA study, titled 'Symptom-Based Dosing for Neonatal Opioid Withdrawal: The OPTimize NOW Randomized Clinical Trial,' involved 626 infants across 23 hospitals in the United States, with 383 infants in the primary outcome cohort who were cared for using the Eat, Sleep, Console approach. The clinical trial was a stepped-wedge cluster randomized controlled trial with a transition period. A clinical trial found that a symptom-based treatment approach reduced the need for opioid medication in infants.

More than 100 researchers across the United States contributed to the study, including nearly two dozen hospitals nationwide. Participating locations included neonatal intensive care units at Norton Children's Hospital, Norton Women's & Children's Hospital, and UofL Hospital. The study was funded by the National Institutes of Health, with support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the NIH HEAL Initiative. Sucheta Telang, Scott Duncan, and Ryan Smith, faculty members at the University of Louisville, were co-authors on the study.

Lori A. Devlin is a professor in the University of Louisville School of Medicine Department of Pediatrics and a neonatologist with Norton Children's. This work represents a true team effort involving researchers, nurses, administrators and families across the nation, including our team at Norton Children's Research Institute and the UofL Department of Pediatrics, Devlin said. Our team is currently conducting another multicenter study to determine the best type of medication for NOWS, Devlin said.

Neonatal opioid withdrawal syndrome can develop when mothers ingest opioids during pregnancy, causing infants to experience withdrawal symptoms such as irritability, difficulty with feeding, and sleeping concerns after birth. The Eat, Sleep, Console model of care includes family involvement, holding, and swaddling before prescribing medication. Over 1,000 babies are born with neonatal opioid withdrawal syndrome in Kentucky each year.

Lori A. Devlin previously led the ESC-NOW trial, which showed that the family-centered Eat, Sleep, Console approach reduced hospital stays by about a week. The ESC-NOW trial showed that the need for medication decreased from 52% to 19%.