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Symptom-Based Dosing for Neonatal Opioid Withdrawal: The OPTimize NOW Randomized Clinical Trial.

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Title: Symptom-Based Dosing for Neonatal Opioid Withdrawal: The OPTimize NOW Randomized Clinical Trial.
Authors: Devlin LA; Norton Children's Neonatology, affiliated with the University of Louisville School of Medicine, Louisville, Kentucky., Babineau DC; Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina., Merhar SL; Department of Pediatrics, University of Cincinnati College of Medicine and Perinatal Institute, Division of Neonatology, Cincinnati Children's Hospital Medical Center, Good Samaritan Hospital, Cincinnati, Ohio.; St Elizabeth Healthcare Edgewood Hospital, Edgewood, Kentucky., DeMauro SB; Division of Neonatology, Children's Hospital of Philadelphia, Pennsylvania.; Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia., Kraft WK; Department of Pharmacology, Physiology & Cancer Biology, Thomas Jefferson University, Philadelphia, Pennsylvania., Lorch SA; Division of Neonatology, Children's Hospital of Philadelphia, Pennsylvania.; Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia., Das A; Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina., McDonald SA; Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina., Rhodes E; Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina., Schmidt AF; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland., Trochinski L; Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina., Crawford M; Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina., Sithisarn T; Department of Pediatrics, Golisano Children's at University of Kentucky, Lexington., Leeman L; Department of Family and Community Medicine, The University of New Mexico School of Medicine, Albuquerque., Kovatis KZ; Division of Neonatology, Department of Pediatrics, ChristianaCare, Newark, Delaware., Ambalavanan N; Division of Neonatology, Department of Pediatrics, The University of Alabama at Birmingham., Smith RW; Department of Pediatrics, University of Louisville School of Medicine/Norton Women's and Children's Hospital, Louisville, Kentucky., Telang S; Department of Pediatrics, University of Louisville School of Medicine/Norton Children's Hospital, Louisville, Kentucky., Tioseco JA; Children's Hospital of Philadelphia Newborn Care, AtlantiCare Regional Medical Center, Pomona, New Jersey., McAllister JM; Department of Pediatrics, University of Cincinnati College of Medicine and Perinatal Institute, Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio., Wexelblatt SL; Department of Pediatrics, University of Cincinnati College of Medicine and Perinatal Institute, Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio., Muniyappa B; Department of Pediatrics, Division of General Pediatrics, University of Utah School of Medicine, Salt Lake City., Williams PK; Section of Neonatology, Department of Pediatrics, Oklahoma Children's Hospital, OU Health, University of Oklahoma Health Center, Oklahoma City., Adeniyi-Jones SC; Department of Pediatrics, Sidney Kimmel Medical College, Thomas Jefferson University/Nemours Children's Health, Philadelphia, Pennsylvania., Hill CD; Kettering Health, Kettering, Ohio.; Perinatal Institute, Division of Neonatology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio., Wright T; Department of Pediatrics, University of South Florida, Tampa., Sokol GM; Department of Pediatrics, Indiana University School of Medicine, Indianapolis., Johnson L; University of Rochester School of Medicine & Dentistry, Rochester, New York., Hall RW; Department of Pediatrics/Neonatology, University of Arkansas for Medical Sciences, Little Rock., Duncan SD; Department of Pediatrics, University of Louisville School of Medicine/University of Louisville Hospital, Louisville, Kentucky., Puopolo K; Division of Neonatology, Children's Hospital of Philadelphia, Pennsylvania.; Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia., Dummula K; Department of Pediatrics, University of Kansas Medical Center, Kansas City.; Children's Mercy Hospital, Kansas City, Missouri., Anderson-Berry A; Department of Pediatrics, University of Nebraska Medical Center, Omaha., Davis JM; Department of Pediatrics and Tufts Clinical and Translational Science Institute, Tufts Medical Center, Boston, Massachusetts., Poindexter B; Division of Neonatology, Emory University School of Medicine, Atlanta, Georgia., Young LW; Larner College of Medicine at the University of Vermont, Burlington.
Corporate Authors: HEAL Evaluation of Limited Pharmacotherapies for Neonatal Opioid Withdrawal Syndrome (HELP for NOWS) Consortium
Source: JAMA [JAMA] 2026 Jun 23; Vol. 335 (24), pp. 2114-2125.
Publication Type: Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial
Journal Info: Publisher: American Medical Association Country of Publication: United States NLM ID: 7501160 Publication Model: Print Cited Medium: Internet ISSN: 1538-3598 (Electronic) Linking ISSN: 00987484 NLM ISO Abbreviation: JAMA Subsets: MEDLINE
Database: MEDLINE Ultimate
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Department of Pharmacology, Physiology & Cancer Biology, Thomas Jefferson University, Philadelphia, Pennsylvania.<br /><searchLink fieldCode="AU" term="%22Lorch+SA%22">Lorch SA</searchLink>; Division of Neonatology, Children's Hospital of Philadelphia, Pennsylvania.; Department of Pediatrics, Perelman School of Medicine, University of Pennsylvania, Philadelphia.<br /><searchLink fieldCode="AU" term="%22Das+A%22">Das A</searchLink>; Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina.<br /><searchLink fieldCode="AU" term="%22McDonald+SA%22">McDonald SA</searchLink>; Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina.<br /><searchLink fieldCode="AU" term="%22Rhodes+E%22">Rhodes E</searchLink>; Data Analytics and Digital Solutions, RTI International, Research Triangle Park, North Carolina.<br /><searchLink fieldCode="AU" term="%22Schmidt+AF%22">Schmidt AF</searchLink>; Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.<br /><searchLink fieldCode="AU" term="%22Trochinski+L%22">Trochinski L</searchLink>; 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