One shot to save tiny brains: new trial for preemies

NCT ID NCT06572917

Not yet recruiting Prevention Sponsor: University of British Columbia Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tests whether a single low dose of the drug indomethacin, given within 12 hours of birth, can prevent severe brain bleeding and improve survival in extremely preterm infants (born before 26 weeks or weighing under 750 grams). About 500 babies across Canada, the US, and Australia will be randomly assigned to receive either the drug or a placebo. Researchers and caregivers will not know which baby gets what, to keep the results unbiased.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: indomethacin
What this could lead to: If it works, this could offer a simple, one-time treatment to prevent severe brain bleeding and improve survival in the tiniest newborns.
What could go wrong: This is a Phase 2 trial, so it is still early. The drug may not work as hoped, and there are known risks like gut problems or harm when used with other medications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

perinatal disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

EXTREME PREMATURITY INTRAVENTRICULAR HEMORRHAGE MORBIDITY;NEWBORN

Contacts and locations

Locations

BC Women's Hospital

Vancouver, British Columbia, V6H 3N1, Canada
CHU de Quebec

Québec, Quebec, Canada
Foothills Medical Center & Alberta Children's Hospital

Calgary, Alberta, Canada
IWK Health

Halifax, Nova Scotia, Canada
Kaiser Roseville

Roseville, California, 95661, United States
Mercy Hospital for Women

Melbourne, Victoria, Australia
Monash Children's Hospital

Melbourne, Victoria, Australia
Montreal Children's Hospital

Montreal, Quebec, Canada
Royal Alexandra Hospital

Edmonton, Alberta, Canada
Royal Columbian Hospital

New Westminster, British Columbia, Canada
Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada
Texas Health Harris Methodist Hospital Fort Worth

Fort Worth, Texas, 76104, United States
UC Davis Health

Sacramento, California, 95817, United States
University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15224-1334, United States
Welcome to Baylor Scott & White Health

Fort Worth, Texas, 76104, United States

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