Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach
Public ClinicalTrials.gov record NCT05980260. 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.
This clinical trial will help us learn more about how to best care for babies with Neonatal Opioid Withdrawal Syndrome, also called NOWS. Babies with NOWS often have tremors, a hard time sleeping, excessive crying, and trouble feeding. Some babies that have NOWS need medicine. Doctors have two ways of providing medicine that are widely used today: 1. Scheduled opioid taper approach. The baby gets medicine at regular times. As symptoms get better, the amount of medicine the baby gets decreases until the baby no longer needs medicine. This is called a medicine taper. 2. Symptom-based approach. The baby will only get medicine when they show signs of NOWS, instead of at regular times. If the baby is showing no signs of NOWS, no medicine will be given. We are doing the OPTimize NOW study to figure out the best way to give medicine to babies with NOWS.
Study identification
- NCT ID
- NCT05980260
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 626 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 1 Hour to 48 Hours
- 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
- Mar 25, 2024 (Actual)
- Primary completion
- May 27, 2025 (Actual)
- Completion
- Jul 15, 2025 (Actual)
- Last update posted
- Oct 29, 2026
2024 – 2025
United States locations
- U.S. sites
- 23
- U.S. states
- 15
- U.S. cities
- 19
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | — |
| ChristianaCare | Wilmington | Delaware | 19801 | — |
| University of South Florida Health | Tampa | Florida | 33606 | — |
| Sidney & Lois Eskenazi Hospital | Indianapolis | Indiana | 46202 | — |
| University of Louisville Hospital | Jeffersonville | Indiana | 47130 | — |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | — |
| St. Elizabeth Healthcare | Edgewood | Kentucky | 41017 | — |
| Kentucky Children's Hospital | Lexington | Kentucky | 40536 | — |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | — |
| Norton Women's and Children's Hospital | Louisville | Kentucky | 40207 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| AtlantiCare Regional Medical Center | Atlantic City | New Jersey | 08401 | — |
| University of New Mexico Health Sciences Center | Albuquerque | New Mexico | 87131 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Good Samaritan Hospital | Cincinnati | Ohio | 45202 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Kettering Health Main Campus | Kettering | Ohio | 45429 | — |
| Oklahoma Children's Hospital OU Health | Oklahoma City | Oklahoma | 73104 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19107 | — |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | — |
| University of Utah Health | Salt Lake City | Utah | 84158 | — |
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 NCT05980260, 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 Oct 29, 2026 · Synced Oct 31, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05980260 live on ClinicalTrials.gov.