Journal article
Accelerated Weaning of Opioids to Reduce Pharmacologic Exposure for Neonatal Opioid Withdrawal Syndrome: A Randomized Clinical Trial
The Journal of pediatrics, 114992
01/17/2026
DOI: 10.1016/j.jpeds.2026.114992
PMID: 41554434
Abstract
To determine if newborns receiving morphine or methadone as the primary pharmacologic treatment for neonatal opioid withdrawal syndrome (NOWS) tolerate and receive fewer days of opioid using an accelerated wean protocol (15% decrements) compared with using a slower wean protocol (10% decrements).
Newborns ≥ 36 weeks of gestation receiving morphine or methadone for NOWS were enrolled in a pragmatic blinded, randomized multicenter trial. Newborns underwent protocol-driven weaning with decreasing opioid doses of either 15% or 10% decrements. Weaning was encouraged every 24 hours and if signs of NOWS worsened, the preceding dose was resumed. To maintain blinding, the last 3 dose levels of the 15% decrements were placebo. The primary outcome was the number of days of opioid treatment from the first weaning dose to cessation of opioids.
Slow enrollment prompted early trial closure; 189 newborns were randomized, 98 (51.9%) to 15% decrements (mean ± standard deviation, 38.8±1.2 weeks gestation, 59.8% male) and 91 (48.1%) to 10% decrements (38.8±1.3 weeks gestation, 61.5% male). Morphine was used most commonly. Intention to treat analysis included all but 4 infants withdrawn in the 15% decrement group. The durations of opioid treatment during weaning were 8.2 (7.2, 9.5) (adjusted mean [95% confidence interval]) and 11.2 (9.7, 12.9) days for 15% and 10% decrement groups, respectively (p<0.001). Adverse events were few in both groups.
Pharmacologic treatment of NOWS using an accelerated wean protocol (15% decrements) was well tolerated with fewer days of opioid treatment compared with 10% decrements.
Details
- Title: Subtitle
- Accelerated Weaning of Opioids to Reduce Pharmacologic Exposure for Neonatal Opioid Withdrawal Syndrome: A Randomized Clinical Trial
- Creators
- Abbot R. Laptook - Brown UniversityAdam Czynski - Connecticut Children's Medical CenterRouba Chahine - RTI InternationalRachel G. Greenberg - Duke Clinical Research Institute, Durham, NCP Brian Smith - Duke UniversityErica Oliveira - Women & Infants Hospital of Rhode IslandJenna Gabrio - RTI InternationalBarry Eggleston - RTI InternationalAbhik Das - RTI InternationalJeannette Lee - University of Arkansas for Medical SciencesBarry Lester - Brown UniversityDave Clark - National Institute of Child HealthMichele Walsh - National Institute of Child HealthHelen Ko - University of New MexicoClare Campbell Asher - University of Arkansas for Medical SciencesHayley Friedman - Washington University in St. LouisSamuel Gentle - University of Alabama at BirminghamKarishma Rao - Children's Mercy HospitalAnup Katheria - Sharp Mary Birch Hospital for Women & NewbornsKristen Benninger - Nationwide Children's HospitalSanket Jani - Central Michigan UniversityMark Cody Smith - West Virginia University HospitalsAkram Khan - Sanford HealthAjay Talati - University of Tennessee Health Science CenterShaina Lodhi - Loma Linda UniversityFernando Mena - MedStar Franklin Square Medical CenterAmanda England - Ochsner Baptist Medical CenterPrabhu Parimi - MetroHealth Medical CenterRanjit Kylat - University of ArizonaHeidi Harmon - University of IowaJaved Mannan - UMass Memorial Medical CenterMeghan P. Howell - Tulane UniversityTanner Wright - University of South FloridaJessica Snowden - University of Tennessee Health Science CenterACT NOW Collaborative
- Resource Type
- Journal article
- Publication Details
- The Journal of pediatrics, 114992
- DOI
- 10.1016/j.jpeds.2026.114992
- PMID
- 41554434
- NLM abbreviation
- J Pediatr
- ISSN
- 0022-3476
- eISSN
- 1097-6833
- Publisher
- Elsevier Inc
- Language
- English
- Electronic publication date
- 01/17/2026
- Academic Unit
- Stead Family Department of Pediatrics; Neonatology
- Record Identifier
- 9985130059402771
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