Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome (NCT07278375)
🩺 Plain-English Summary (8th-Grade Level)
The goal of this observational study is to learn how two medicines used in routine care-buprenorphine and morphine-affect recovery in newborns (≥36 weeks' gestation) with Neonatal Opioid Withdrawal Syndrome (NOWS). The main questions it aims to answer are: 1. Do infants treated with buprenorphine become medically ready for discharge sooner than those treated with morphine? 2. Does one treatment lead to better overall clinical outcomes than the other? Researchers will compare infants who received buprenorphine with infants who received morphine to see whether one treatment helps babies recover more quickly. Participants will not be asked to do anything. Instead, the study team will collect information already documented in the infant's and mother's medical records securely without any contact or changes to clinical care. No new medicines, procedures, or visits are involved. This study only reviews existing clinical data to better understand which commonly used treatment may support faster recovery for newborns with NOWS.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (7 items).
Location: University of Alabama at Birmingham — Birmingham, Alabama
Age range: 0 Minutes
📋 "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:
- Infant has major congenital anomalies.
- Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed prior to the initiation of pharmacologic treatment.
- Infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.
- Infant has undergone major surgical intervention prior to or at 48 hours of age.
- Infant has postnatal opioid exposure prior to the initiation of pharmacologic treatment for NOWS.
- Infant was outborn and pharmacologic treatment was initiated at the transferring hospital.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (22 Sites)
- University of Alabama at Birmingham — Birmingham, Alabama
- University of Arkansas for Medical Sciences — Little Rock, Arkansas
- ChristianaCare — Wilmington, Delaware
- University of South Florida Health — Tampa, Florida
- Riley Hospital for Children at IU Health — Indianapolis, Indiana
- Sidney & Lois Eskenazi Hospital — Indianapolis, Indiana
- University of Louisville Hospital — Jeffersonville, Indiana
- St. Elizabeth Healthcare — Edgewood, Kentucky
- Kentucky Children's Hospital — Lexington, Kentucky
- Norton Children's Hospital — Louisville, Kentucky
- Norton Women's and Children's Hospital — Louisville, Kentucky
- Children's Regional Hospital, Cooper University Health Care — Camden, New Jersey
- University of New Mexico Health Sciences Center — Albuquerque, New Mexico
- University of Rochester Medical Center — Rochester, New York
- Good Samaritan Hospital — Cincinnati, Ohio
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
- Rainbow Babies and Children's Hospital — Cleveland, Ohio
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
- Pennsylvania Hospital — Philadelphia, Pennsylvania
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania
- University of Utah Health — Salt Lake City, Utah
- University of Vermont Medical Center — Burlington, Vermont
📞 Contact the Study Coordinator
Phone: (215) 955-9077
Email: Walter.Kraft@jefferson.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 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
- ACT NOW Longitudinal Study: Outcomes of Babies With Opioid Exposure Study — Birmingham, Alabama
- Neurostimulation to Improve NOWS Outcomes — Charleston, South Carolina
- Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS) — Birmingham, Alabama
Explore by condition: All Neonatal Opioid Withdrawal Syndrome clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.