A major new study shows that individualized treatment for babies born with opioid withdrawal can speed recovery and reduce time spent in the hospital.
The clinical trial led by Lori A. Devlin , professor in the University of Louisville School of Medicine Department of Pediatrics and neonatologist with Norton Children’s, found a customized approach to treating babies with opioid withdrawal helps them recover faster than current standardized practices.
The findings were recently published in the Journal of the American Medical Association (JAMA) , one of the nation’s leading medical journals. More than 100 researchers across the country contributed to the study.
Every year, over 1,000 Kentucky babies are born with neonatal opioid withdrawal syndrome (NOWS ). The syndrome can develop when mothers ingest opioids during pregnancy, causing the infant to experience withdrawal symptoms after birth. Those symptoms can include irritability, difficulty with feeding and sleeping concerns.
The study compared two treatments: a fixed medication schedule and a symptom-based approach that adjusts care based on the severity of each infant’s symptoms. Results showed babies treated with the symptom-based approach recovered faster.
When this individualized treatment was combined with the Eat, Sleep, Console (ESC) model of care – which includes family involvement, holding and swaddling before prescribing medication – infants with NOWS left the hospital an average of 2.3 days sooner. Notably, 65% of babies treated with this approach did not need scheduled opioid medications and gradual weaning.
“These findings confirm that ESC, combined with symptom-based dosing, helps babies recover faster and reduces unnecessary medication exposure,” Devlin said. “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.”
Nearly two dozen hospitals nationwide participated in the study, including neonatal intensive care units (NICU) at Norton Children’s Hospital, Norton Women’s & Children’s Hospital and UofL Hospital.
The study builds on more than a decade of research aimed at improving care for infants with NOWS. Devlin previously led the ESC-NOW trial that showed using the family-centered ESC approach reduced hospital stays by about a week and decreased the need for medication from 52% to 19%.
“This research is actively changing how babies with NOWS are treated around the world,” Devlin said. “Our team is currently conducting another multicenter study to determine the best type of medication for NOWS.”
UofL faculty members Sucheta Telang, Scott Duncan and Ryan Smith were co-authors on the study.
The study was funded by the National Institutes of Health (NIH), with support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the NIH HEAL (Helping to End Addiction Long-term) Initiative.
JAMA
Randomized controlled/clinical trial
People
Symptom-Based Dosing for Neonatal Opioid Withdrawal
25-Apr-2026
Dr Devlin reported receiving grants from the National Institutes of Health (NIH) during the conduct of the study. Dr Babineau reported receiving grants from NIH during the conduct of the study. Dr Merhar reported receiving grants from NIH during the conduct of the study. Dr DeMauro reported receiving grants from NIH during the conduct of the study and outside the submitted work. Dr Kraft reported receiving grants from Thomas Jefferson University (UG1HD107628) during the conduct of the study; grants from Merck, Pfizer, and Rhoshan; personal fees from AbbVie, Johnson & Johnson, and Sun Pharma outside the submitted work; and having a patent pending (US-20200330455-A1). Dr Lorch reported receiving grants from NIH during the conduct of the study. Dr Das reported receiving grant funding from NIH to support this work. Mr McDonald reported receiving grant funding from NIH to support this work. Mr Rhodes reported receiving grant funding from NIH to support this work. Ms Crawford reported receiving grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) during the conduct of the study. Dr Sithisarn reported receiving grants from NIH during the conduct of the study; grants from NIH Non-Opiate Treatment After Prenatal Opiate Exposure to Prevent Postnatal Injury to the Young Brain (No-POPPY), National Institute on Drug Abuse POPI: Placenta, Opioids and Perinatal Implications study, and Research Triangle Institute/NIH Treat NOW Study – Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome outside the submitted work. Dr Ambalavanan reported receiving grants from NIH during the conduct of the study and having a patent pending for vital signs analysis for identification of opioid exposure in infants. Dr Smith reported receiving grants from NIH during the conduct of the study. Dr Wexelblatt reported receiving personal fees from Sanofi and Abbott for serving on the speakers bureau outside the submitted work. Dr Williams reported receiving grants from NIH during the conduct of the study. Dr Adeniyi-Jones reported receiving grants from NIH during the conduct of the study. Dr Hill reported receiving grants from NIH during the conduct of the study. Dr Wright reported receiving grants from NIH during the conduct of the study and grants from US Centers for Disease Control and Prevention, Hillsborough County, and NIH Helping to End Addiction Long-Term (HEAL) outside the submitted work. Dr Sokol reported receiving grants from NIH during the conduct of the study. Dr Hall reported receiving grants from NIH during the conduct of the study. Dr Duncan reported receiving grants from Medtronic, Pfizer, and Oak Hill Bio outside the submitted work. Dr Puopolo reported receiving grants from NIH during the conduct of the study. Dr Dummula reported receiving grants from NIH during the conduct of the study. Dr Davis reported receiving grants from NIH to his institution during the conduct of the study and consulting fees from Inflection Medicine outside the submitted work. Dr Young reported receiving grants from NIH during the conduct of the study. No other disclosures were reported.