Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05980260 · ClinicalTrials.gov registry record · Phase 3
Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach
A Phase 3 study, sponsored by HELP for NOWS Consortium.
- Completed
- Registry status
- Phase 3
- Development phase
- 626
- Enrollment target
NCT05980260 is a Phase 3 study that has completed, run by HELP for NOWS Consortium. The registered enrollment target is 626 participants.
The verdict
NCT05980260, a Phase 3 study, has completed, sponsored by HELP for NOWS Consortium.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 626 participants
- Enrollment target
Study Summary
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.
Interventions
- OTHER Symptom-based Dosing Approach
- OTHER Scheduled Opioid Taper Approach
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 626 participants |
| Start Date | 2024-03-25 |
| Est. Completion | 2025-07-15 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05980260
The ClinicalTrials.gov registry entry for NCT05980260 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 626 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 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Symptom-based Dosing Approach is the first listed.
NCT05980260 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05980260 about?
NCT05980260 is a clinical study titled "Optimizing Pharmacologic Treatment for Neonatal Opioid Withdrawal Syndrome (OPTimize NOW): A Symptom-Based Dosing Approach". 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 ...
What is the current status of trial NCT05980260?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 626 participants. The study started on 2024-03-25. Estimated completion is 2025-07-15.
What interventions are being tested in trial NCT05980260?
The interventions under investigation include: Symptom-based Dosing Approach (OTHER), Scheduled Opioid Taper Approach (OTHER).
Who is sponsoring clinical trial NCT05980260?
This trial is sponsored by HELP for NOWS Consortium, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.