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Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
Sponsor: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program
Summary
The objective of this study is to evaluate the efficacy of a rapid wean intervention compared with a slow-wean intervention in reducing the number of days of opioid treatment from the first dose of weaning to cessation of opioid among infants receiving an opioid (defined as morphine or methadone) as the primary treatment for neonatal opioid withdrawal syndrome (NOWS).
Official title: Pragmatic, Randomized, Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
Key Details
Gender
All
Age Range
36 Weeks - Any
Study Type
INTERVENTIONAL
Enrollment
189
Start Date
2020-09-28
Completion Date
2026-06-30
Last Updated
2025-03-13
Healthy Volunteers
No
Conditions
Interventions
Morphine
The dose interval for morphine will be either every 3 or 4 hours, per hospital practice. Clinical teams are asked to wean study drug at least every 24 hours.
Methadone
The dose interval for methadone will be every 8 or 12 hours, per hospital practice. Clinical teams are asked to wean study drug at least every 24 hours.
Locations (24)
University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Arizona
Tucson, Arizona, United States
University of Arkansas Medical Sciences
Little Rock, Arkansas, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States
University of Iowa
Iowa City, Iowa, United States
Ochsner Medical Regional Hospital
Kenner, Louisiana, United States
Tulane University Health Science Center
New Orleans, Louisiana, United States
Ochsner Baptist Clinical Trials Unit
New Orleans, Louisiana, United States
MedStar Franklin Square
Hyattsville, Maryland, United States
University of Massachusetts Memorial Medical Center-West Campus
Worcester, Massachusetts, United States
Central Michigan University
Detroit, Michigan, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of New Mexico
Albuquerque, New Mexico, United States
RTI International
Durham, North Carolina, United States
Metrohealth
Cleveland, Ohio, United States
Nationwide Childeren's Hospital
Columbus, Ohio, United States
Ohio State University Hospital
Columbus, Ohio, United States
Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
Sanford Health
Sioux Falls, South Dakota, United States
University of Tennessee Health Science Center
Memphis, Tennessee, United States
The University of Tennessee Health Science Center
Memphis, Tennessee, United States
West Virginia University Hospital
Morgantown, West Virginia, United States