{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T03:21:00Z","timestamp":1788405660435,"version":"build-2803163510"},"reference-count":24,"publisher":"American Medical Association (AMA)","issue":"24","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA"],"published-print":{"date-parts":[[2026,6,23]]},"abstract":"\n Importance<\/jats:title>\n Infants with neonatal opioid withdrawal syndrome (NOWS) who receive pharmacologic treatment are traditionally treated with a scheduled opioid taper. An alternate approach, symptom-based dosing, may better align treatment with withdrawal severity.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To compare time from birth to medical readiness for discharge for infants with moderate to severe withdrawal treated with either a symptom-based dosing or scheduled opioid taper approach.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n In this cluster, crossover randomized clinical trial with run-in period, 23 US hospitals cared for infants using the Eat, Sleep, Console approach (ESC) or Finnegan-based care (a comprehensive scoring system to quantify severity of symptoms; 15 ESC and 8 Finnegan hospitals) and their preferred primary opioid. Opioid dosing was guided by study-approved, site-specific algorithms. Infants with NOWS with a gestational age at birth of at least 36 weeks and at risk for pharmacologic treatment were enrolled between March 25, 2024, and April 9, 2025, with the last 3-month assessment on July 15, 2025. Sample size analyses were conducted between August 1, 2024, and September 23, 2024.<\/jats:p>\n <\/jats:sec>\n \n Intervention<\/jats:title>\n Sites were randomized to 1 of 2 sequences: (1) symptom-based dosing followed by scheduled opioid taper or (2) scheduled opioid taper followed by symptom-based dosing.<\/jats:p>\n <\/jats:sec>\n \n Main Outcome and Measure<\/jats:title>\n Time from birth to medical readiness for discharge.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Of the 626 enrolled infants (mean [SD] gestational age, 38 [1] weeks; 49% male), 383 were cared for with ESC (primary outcome cohort). The mean time to medical readiness for discharge was significantly shorter in the symptom-based dosing group compared with the scheduled opioid taper group (9.18 vs 11.61 days; adjusted mean ratio [aMR], 0.79 [95% CI, 0.65-0.96]). There was no difference in the risk for initiation of pharmacologic treatment (0.4 vs 0.41; adjusted risk ratio, 0.99 [95% CI, 0.77-1.27]) or length of stay (10.91 vs 12.09 days; aMR, 0.9 [95% CI, 0.72-1.13]) between groups. For infants in the symptom-based group, 35% (95% CI, 25%-45%) required scheduled opioid dosing due to withdrawal severity that was not controlled with intermittent dosing. In the Finnegan cohort (n\u2009=\u2009243; planned secondary outcome), there were no significant differences in time to medical readiness for discharge (15.99 vs 17.56 days; aMR, 0.91 [95% CI, 0.72-1.15]) or length of stay (17.38 vs 19.39 days; aMR, 0.9 [95% CI, 0.69-1.16]). The inpatient composite safety outcome occurred rarely (in the ESC cohort, 3 of 188 in the symptom-based dosing vs 2 of 195 in the scheduled opioid taper groups).<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n Symptom-based dosing decreased time to medical readiness for discharge compared with a scheduled opioid taper approach among infants cared for with ESC.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT05980260<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jama.2026.5782","type":"journal-article","created":{"date-parts":[[2026,4,25]],"date-time":"2026-04-25T16:30:16Z","timestamp":1777134616000},"page":"2114","source":"Crossref","is-referenced-by-count":4,"title":["Symptom-Based Dosing for Neonatal Opioid Withdrawal"],"prefix":"10.1001","volume":"335","author":[{"given":"Lori A.","family":"Devlin","sequence":"first","affiliation":[{"name":"Norton Children\u2019s Neonatology, affiliated with the University of Louisville School of Medicine, Louisville, Kentucky"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Denise C.","family":"Babineau","sequence":"additional","affiliation":[{"name":"Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephanie L.","family":"Merhar","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Cincinnati College of Medicine and Perinatal Institute, Division of Neonatology, Cincinnati Children\u2019s Hospital Medical Center, Good Samaritan Hospital, Cincinnati, Ohio"},{"name":"St Elizabeth Healthcare Edgewood Hospital, Edgewood, Kentucky"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara B.","family":"DeMauro","sequence":"additional","affiliation":[{"name":"Division of Neonatology, Children\u2019s Hospital of Philadelphia, Pennsylvania"},{"name":"Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter K.","family":"Kraft","sequence":"additional","affiliation":[{"name":"Department of Pharmacology, Physiology & Cancer Biology, Thomas Jefferson University, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott A.","family":"Lorch","sequence":"additional","affiliation":[{"name":"Division of Neonatology, Children\u2019s Hospital of Philadelphia, Pennsylvania"},{"name":"Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abhik","family":"Das","sequence":"additional","affiliation":[{"name":"Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott A.","family":"McDonald","sequence":"additional","affiliation":[{"name":"Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evan","family":"Rhodes","sequence":"additional","affiliation":[{"name":"Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Augusto F.","family":"Schmidt","sequence":"additional","affiliation":[{"name":"Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lillian","family":"Trochinski","sequence":"additional","affiliation":[{"name":"Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Margaret","family":"Crawford","sequence":"additional","affiliation":[{"name":"Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thitinart","family":"Sithisarn","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Golisano Children\u2019s at University of Kentucky, Lexington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Leeman","sequence":"additional","affiliation":[{"name":"Department of Family and Community Medicine, The University of New Mexico School of Medicine, Albuquerque"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelley Zagol","family":"Kovatis","sequence":"additional","affiliation":[{"name":"Division of Neonatology, Department of Pediatrics, ChristianaCare, Newark, Delaware"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Namasivayam","family":"Ambalavanan","sequence":"additional","affiliation":[{"name":"Division of Neonatology, Department of Pediatrics, The University of Alabama at Birmingham"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan W.","family":"Smith","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Louisville School of Medicine\/Norton Women\u2019s and Children\u2019s Hospital, Louisville, Kentucky"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sucheta","family":"Telang","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Louisville School of Medicine\/Norton Children\u2019s Hospital, Louisville, Kentucky"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer A.","family":"Tioseco","sequence":"additional","affiliation":[{"name":"Children\u2019s Hospital of Philadelphia Newborn Care, AtlantiCare Regional Medical Center, Pomona, New Jersey"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer M.","family":"McAllister","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Cincinnati College of Medicine and Perinatal Institute, Division of Neonatology, Cincinnati Children\u2019s Hospital Medical Center, Cincinnati, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Scott L.","family":"Wexelblatt","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Cincinnati College of Medicine and Perinatal Institute, Division of Neonatology, Cincinnati Children\u2019s Hospital Medical Center, Cincinnati, Ohio"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bhanu","family":"Muniyappa","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Division of General Pediatrics, University of Utah School of Medicine, Salt Lake City"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patricia K.","family":"Williams","sequence":"additional","affiliation":[{"name":"Section of Neonatology, Department of Pediatrics, Oklahoma Children\u2019s Hospital, OU Health, University of Oklahoma Health Center, Oklahoma City"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan C.","family":"Adeniyi-Jones","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Sidney Kimmel Medical College, Thomas Jefferson University\/Nemours Children\u2019s Health, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Crystal D.","family":"Hill","sequence":"additional","affiliation":[{"name":"Kettering Health, Kettering, Ohio"},{"name":"Perinatal Institute, Division of Neonatology, Cincinnati Children\u2019s Hospital Medical Center, Cincinnati, 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D.","family":"Duncan","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Louisville School of Medicine\/University of Louisville Hospital, Louisville, Kentucky"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen","family":"Puopolo","sequence":"additional","affiliation":[{"name":"Division of Neonatology, Children\u2019s Hospital of Philadelphia, Pennsylvania"},{"name":"Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krishna","family":"Dummula","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Kansas Medical Center, Kansas City"},{"name":"Children\u2019s Mercy Hospital, Kansas City, Missouri"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ann","family":"Anderson-Berry","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, University of Nebraska 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