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NCT06572917 · ClinicalTrials.gov registry record · Phase 2
Single-dose Prophylactic INdomethacin in Extremely Preterm Infants
A Phase 2 study, sponsored by University of British Columbia.
- Not yet
- Registry status
- Phase 2
- Development phase
- 500
- Enrollment target
NCT06572917: Clinical Trial Phase 2 study, sponsored by University of British Columbia.
NCT06572917 is a Phase 2 study that has not yet begun recruiting, run by University of British Columbia. The registered enrollment target is 500 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (276% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06572917, a Phase 2 study, has not yet begun recruiting, sponsored by University of British Columbia.
- NOT YET RECRUITING
- Registry status
- Phase 2
- Development phase
- 500 participants
- Enrollment target
Study Summary
In Canada, about 900 babies each year are born very early (\<26 weeks of gestation) and have a high chance of dying or having a serious bleed in the brain. Families of these extremely preterm babies consider preventing severe brain bleeding as critical to their child's health and well-being. A medicine called indomethacin, when given intravenously in 3-doses, is known to reduce severe brain bleeding. But use of this drug is variable among clinicians working in the neonatal intensive care unit (NICU) due to (a) its side effects on the gut; (b) possible harm when used with other medications; (c) a notion that despite reducing brain bleeds, the child's long-term brain development is not improved. Emerging evidence suggests that a single low-dose indomethacin regimen may be equally effective in reducing severe brain bleeding as compared to a traditional 3-dose regimen. The investigators propose a blinded randomized controlled trial, a study design where babies born \<26 weeks will be randomly assigned within 12 hours of birth to either a single dose of intravenous indomethacin or similar looking placebo in the form a saline solution. The study will test if a single dose indomethacin regimen is effective in improving survival of these babies without the devastating complication of severe brain bleeding. In this study the care providers and researchers will be unaware as to which baby receives indomethacin and which baby receives placebo to ensure no one's expectations or biases can influence the results. The investigators will conduct the study in multiple NICUs across Canada, the United States and Australia in 2 phases: First, an internal pilot phase that will enroll 104 babies born \<26 weeks or \<750 g birth weight over a period of 1 year. If the investigators are successful in achieving their target enrolment in the pilot phase, they will move on to the second phase and continue enrollment up to a total of 500 babies born \<26 weeks or \<750 g birth weight over a p
Primary Outcome
Any IVH more than grade 2 (i.e., grade 3, grade 4/intraparenchymal hemorrhage/perventricular hemorrhagic infarction is classified as sIVH
Interventions
- DRUG Placebo
- DRUG Indomethacin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2025-11-01 |
| Est. Completion | 2031-03-31 |
| Phase | Phase 2 |
What is known before NCT06572917 opens enrollment
NCT06572917 is an interventional study that assigns participants to a tested intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (276% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06572917 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06572917 about?
NCT06572917 is a clinical study titled "Single-dose Prophylactic INdomethacin in Extremely Preterm Infants". In Canada, about 900 babies each year are born very early (\<26 weeks of gestation) and have a high chance of dying or having a serious bleed in the brain. Families of these extremely preterm babies consider preventing severe brain bleeding as critical to their child's health and well-being. A medic...
What is the current status of trial NCT06572917?
This trial is currently not yet recruiting. It is a Phase 2 study. The enrollment target is 500 participants. The study started on 2025-11-01. Estimated completion is 2031-03-31.
What interventions are being tested in trial NCT06572917?
The interventions under investigation include: Placebo (DRUG), Indomethacin (DRUG).
Who is sponsoring clinical trial NCT06572917?
This trial is sponsored by University of British Columbia, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06572917's enrollment target sits among peer trials
500 70th of 2000 higher than 1,927 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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