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Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
NCT07278375 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07278375
The ClinicalTrials.gov registry entry for NCT07278375 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 796 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is HELP for NOWS Consortium, which has 28 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Neonatal Opioid Withdrawal Syndrome appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07278375 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Kentucky, Indiana, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT07278375?
This trial is sponsored by HELP for NOWS Consortium, which has 28 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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