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: Completed Phase 3 study, sponsored by HELP for NOWS Consortium.
NCT05980260 is a Phase 3 study that has completed, run by HELP for NOWS Consortium. The registered enrollment target is 626 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time from birth until infant meets criteria for medically ready for discharge (days). An infant is considered medically ready for discharge when they are discharged by the medical provider or when they meet the following criteria the following criteria: * ≥ 96 hours of age * ≥ 48 hours since last dose of opioid treatment (i.e., morphine, methadone, or buprenorphine) This primary outcome is for infants assessed and managed using ESC.
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 |
What the finished NCT05980260 record still lists
NCT05980260 is an interventional study that assigns participants to a tested intervention. The registered 626 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (19% lower).
The record links to 0 conditions, and to 2 interventions - of which Symptom-based Dosing Approach is the first listed.
NCT05980260 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT05980260's enrollment target sits among peer trials
626 586th of 2000 higher than 1,415 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06040827 · 626 participants
A Multicenter, Postmarket Surveillance Study of Subjects With the Canary canturioTM te Tibial Extension
- NCT05349227 · 625 participants · NA
Comprehensive Outcomes for After Cancer Health
- NCT06103864 · 625 participants · Phase 3
A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer
- NCT06230510 · 625 participants · NA
Milk-Tot Study: Impact of Whole Versus Low-fat Milk on Child Health
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI