Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
Public ClinicalTrials.gov record NCT04214834. 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.
Official title
Pragmatic, Randomized, Blinded Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04214834
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 189 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 36 Weeks 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
- Sep 28, 2020 (Actual)
- Primary completion
- Jan 31, 2024 (Actual)
- Completion
- Jun 30, 2026 (Estimated)
- Last update posted
- Jun 30, 2026
2020 – 2026
United States locations
- U.S. sites
- 24
- U.S. states
- 17
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| University of Arizona | Tucson | Arizona | 85724 | — |
| University of Arkansas Medical Sciences | Little Rock | Arkansas | 72202 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| Sharp Mary Birch Hospital for Women and Newborns | San Diego | California | 92123 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Ochsner Medical Regional Hospital | Kenner | Louisiana | 70065 | — |
| Tulane University Health Science Center | New Orleans | Louisiana | 70001 | — |
| Ochsner Baptist Clinical Trials Unit | New Orleans | Louisiana | 70115 | — |
| MedStar Franklin Square | Hyattsville | Maryland | 20782 | — |
| University of Massachusetts Memorial Medical Center-West Campus | Worcester | Massachusetts | 01605 | — |
| Central Michigan University | Detroit | Michigan | 48201 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| University of New Mexico | Albuquerque | New Mexico | 87131 | — |
| RTI International | Durham | North Carolina | 27705 | — |
| Metrohealth | Cleveland | Ohio | 44109 | — |
| Nationwide Childeren's Hospital | Columbus | Ohio | 43205 | — |
| Ohio State University Hospital | Columbus | Ohio | 43210 | — |
| Women & Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | — |
| Sanford Health | Sioux Falls | South Dakota | 57104 | — |
| University of Tennessee Health Science Center | Memphis | Tennessee | 38119 | — |
| The University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | — |
| West Virginia University Hospital | Morgantown | West Virginia | 26506 | — |
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 NCT04214834, 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 Jun 30, 2026 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04214834 live on ClinicalTrials.gov.