Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS) (NCT04214834)
Pragmatic, Randomized, Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (12 items).
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 36 Weeks
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Hospital Level 1\. Hospitals discharge \> 10% of infants from the hospital on opioid replacement therapy on average per year
- Infant Level
- Major birth defect (e.g. gastroschisis)
- Any major surgery (minor surgery \[e.g., circumcision, digit ligation, frenulectomy\] is not an exclusion criterion)
- Hypoxic-ischemic encephalopathy
- Seizures from etiologies other than NOWS
- Treatment with opioids for reasons other than NOWS
- Respiratory support (nasal cannula or greater) for \> 72 hours
- Planned discharge from the hospital on opioids
- Use of other opioids (e.g., buprenorphine) as primary drugs for treatment of NOWS
- Weaning of morphine or methadone as the primary treatment of NOWS has started
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (24 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- University of Arizona — Tucson, Arizona
- University of Arkansas Medical Sciences — Little Rock, Arkansas
- Loma Linda University Medical Center — Loma Linda, California
- Sharp Mary Birch Hospital for Women and Newborns — San Diego, California
- University of Iowa — Iowa City, Iowa
- Ochsner Medical Regional Hospital — Kenner, Louisiana
- Tulane University Health Science Center — New Orleans, Louisiana
- Ochsner Baptist Clinical Trials Unit — New Orleans, Louisiana
- MedStar Franklin Square — Hyattsville, Maryland
- University of Massachusetts Memorial Medical Center-West Campus — Worcester, Massachusetts
- Central Michigan University — Detroit, Michigan
- Children's Mercy Hospital — Kansas City, Missouri
- Washington University School of Medicine — St Louis, Missouri
- University of New Mexico — Albuquerque, New Mexico
- RTI International — Durham, North Carolina
- Metrohealth — Cleveland, Ohio
- Nationwide Childeren's Hospital — Columbus, Ohio
- Ohio State University Hospital — Columbus, Ohio
- Women & Infants Hospital of Rhode Island — Providence, Rhode Island
- Sanford Health — Sioux Falls, South Dakota
- University of Tennessee Health Science Center — Memphis, Tennessee
- The University of Tennessee Health Science Center — Memphis, Tennessee
- West Virginia University Hospital — Morgantown, West Virginia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Neonatal Opioid Withdrawal Syndrome
- MicroRNA Biomarkers for Neonatal Opioid Withdrawal Syndrome — Hershey, Pennsylvania
- Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome — Birmingham, Alabama
- ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study — Birmingham, Alabama
- Neurostimulation to Improve NOWS Outcomes — Charleston, South Carolina
Explore by condition: All Neonatal Opioid Withdrawal Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.