Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
Public ClinicalTrials.gov record NCT07278375. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07278375
- Recruitment status
- Recruiting
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 796 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 0 Minutes and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 8, 2025
- Primary completion
- Jun 18, 2026
- Completion
- Aug 29, 2026
- Last update posted
- Feb 24, 2026
2025 – 2026
United States locations
- U.S. sites
- 22
- U.S. states
- 13
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | Recruiting |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205-7199 | Recruiting |
| ChristianaCare | Wilmington | Delaware | 19801 | Not yet recruiting |
| University of South Florida Health | Tampa | Florida | 33606 | Recruiting |
| Riley Hospital for Children at IU Health | Indianapolis | Indiana | 46202-5119 | Recruiting |
| Sidney & Lois Eskenazi Hospital | Indianapolis | Indiana | 46202 | Recruiting |
| University of Louisville Hospital | Jeffersonville | Indiana | 47130 | Not yet recruiting |
| St. Elizabeth Healthcare | Edgewood | Kentucky | 41017 | Not yet recruiting |
| Kentucky Children's Hospital | Lexington | Kentucky | 40536 | Recruiting |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | Not yet recruiting |
| Norton Women's and Children's Hospital | Louisville | Kentucky | 40207 | Not yet recruiting |
| Children's Regional Hospital, Cooper University Health Care | Camden | New Jersey | 08103 | Not yet recruiting |
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | 87131 | Recruiting |
| University of Rochester Medical Center | Rochester | New York | 14642 | Not yet recruiting |
| Good Samaritan Hospital | Cincinnati | Ohio | 45202 | Not yet recruiting |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | Not yet recruiting |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | Not yet recruiting |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | Not yet recruiting |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | Recruiting |
| University of Utah Health | Salt Lake City | Utah | 84158 | Not yet recruiting |
| University of Vermont Medical Center | Burlington | Vermont | 05401 | Not yet recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07278375, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 24, 2026 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07278375 live on ClinicalTrials.gov.