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Preventing Brain Bleeds in Extremely Preterm Infants with Indomethacin

This study is looking at whether a single dose of indomethacin can prevent serious brain bleeds (intraventricular hemorrhage or sIVH) in extremely premature babies. Indomethacin is a medicine that has been shown to reduce these bleeds when given in three doses, but doctors are concerned about its side effects and how it might affect long-term brain development. This study will compare a single dose of indomethacin to a placebo (a harmless inactive substance, like saline) in about 500 extremely preterm infants. We want to see if this single dose can prevent severe brain bleeds without the concerns of the three-dose treatment. You might be able to join if your baby is born very early (less than 26 weeks gestation) or weighs less than 750 grams, and is between 0 and 12 hours old.

Study design
This is an interventional study comparing a single dose of indomethacin to a placebo. About 500 infants are planned to be enrolled.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through hospital discharge, which is approximately 20 weeks postnatal age unless death occurs first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06572917

Single-dose Prophylactic INdomethacin in Extremely Preterm Infants

Not Yet Recruiting
PHASE2Ages 0–12InterventionalPrevention
University of British Columbia
~500 participants
Updated 2025-09-03 on ClinicalTrials.gov
What's tested:IndomethacinPlacebo

At a glance

Recruiting sites
0 of 15 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Survival without severe intraventricular hemorrhage (sIVH)
Measured over through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)

Conditions

Extreme Prematurity
Intraventricular Hemorrhage
Morbidity;Newborn

Explore related trials

Extreme prematurity of infantIntraventricular Brain Hemorrhage

Where it's being run

15 sites across 9 states
California2
Texas2
Victoria2
Alberta2
British Columbia2
Quebec2
Pennsylvania1
Nova Scotia1

Study leadership

  • Souvik Mitra, MD, PhD · PRINCIPAL_INVESTIGATOR · University of British Columbia

Who to contact

Souvik Mitra, MD, PhD
[email protected]
6048752000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Extremely preterm infants born \<26 completed weeks of GA and/or extremely low BW infants born \<750g

Exclusion

antenatal diagnosis of duct dependent CHD
acute hypoxic respiratory failure \[defined as fraction of inspired oxygen (FiO2)\>0.60 for ≥2h)
inhaled nitric oxide (iNO) therapy due to suspected or confirmed acute pulmonary hypertension (PH)
receipt of prophylactic or therapeutic hydrocortisone
antenatal diagnosis of renal anomalies
initial platelet count \<50x109/L
decision to withhold/withdraw life-sustaining treatments

What this trial measures

  • Survival without severe intraventricular hemorrhage (sIVH)through hospital discharge (approximately 20 weeks postnatal age unless death occurs first)

    Any IVH more than grade 2 (i.e., grade 3, grade 4/intraparenchymal hemorrhage/perventricular hemorrhagic infarction is classified as sIVH