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NCT07278375 · ClinicalTrials.gov registry record
Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
A clinical trial of Neonatal Opioid Withdrawal Syndrome, sponsored by HELP for NOWS Consortium.
- Recruiting
- Registry status
- 796
- Enrollment target
- 20
- Study locations
NCT07278375: Recruiting study of Neonatal Opioid Withdrawal Syndrome, sponsored by HELP for NOWS Consortium.
NCT07278375 is a study of Neonatal Opioid Withdrawal Syndrome that is actively recruiting participants, run by HELP for NOWS Consortium. The registered enrollment target is 796 participants, above the 121-participant average among 7 other Neonatal Opioid Withdrawal Syndrome trials with a reported enrollment target (558% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07278375, a study of Neonatal Opioid Withdrawal Syndrome, is actively recruiting participants, sponsored by HELP for NOWS Consortium.
- RECRUITING
- Registry status
- 796 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Number of days from birth until infant meets criteria for medically ready for discharge. An infant is considered medically ready for discharge when they are discharged by the medical provider or when they meet both of the following criteria: * 96 hours of age * 48 hours since last dose of treatment with morphine or buprenorphine
Conditions Studied
Study Locations (20)
Kentucky
- St. Elizabeth Healthcare - Edgewood
- Kentucky Children's Hospital - Lexington
- Norton Children's Hospital - Louisville
- Norton Women's and Children's Hospital - Louisville
Indiana
- Riley Hospital for Children at IU Health - Indianapolis
- Sidney & Lois Eskenazi Hospital - Indianapolis
- University of Louisville Hospital - Jeffersonville
Ohio
- Good Samaritan Hospital - Cincinnati
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Rainbow Babies and Children's Hospital - Cleveland
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- Pennsylvania Hospital - Philadelphia
- Thomas Jefferson University Hospital - Philadelphia
Alabama
- University of Alabama at Birmingham - Birmingham
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Delaware
- ChristianaCare - Wilmington
Florida
- University of South Florida Health - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 796 participants |
| Start Date | 2025-12-09 |
| Est. Completion | 2026-08-30 |
What NCT07278375 shows while recruiting
NCT07278375 is an observational study that tracks outcomes without assigning an intervention. The registered 796 participants enrollment target is mid-sized for trials with a published cap, above the 121-participant average among 7 other Neonatal Opioid Withdrawal Syndrome trials with a reported enrollment target (558% higher).
The record links to 1 condition, with Neonatal Opioid Withdrawal Syndrome appearing as the primary indexed condition, and to 0 interventions.
NCT07278375 names 20 study sites across 11 states, led by Kentucky, Indiana, Ohio.
Frequently Asked Questions
What is clinical trial NCT07278375 about?
NCT07278375 is a clinical study titled "Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome". 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 b...
What is the current status of trial NCT07278375?
This trial is currently recruiting. The enrollment target is 796 participants. The study started on 2025-12-09. Estimated completion is 2026-08-30.
What conditions does trial NCT07278375 study?
This clinical trial studies the following conditions: Neonatal Opioid Withdrawal Syndrome.
Who is sponsoring clinical trial NCT07278375?
This trial is sponsored by HELP for NOWS Consortium, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07278375 being conducted?
This trial has 20 study locations across Alabama, Arkansas, Delaware, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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