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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 is a Phase 2 study that has not yet begun recruiting, run by University of British Columbia. The registered enrollment target is 500 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06572917
The ClinicalTrials.gov registry entry for NCT06572917 describes a study currently listed as not yet recruiting, categorized as Phase 2. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of British Columbia, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT06572917 reports 0 study locations.
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.
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