One dose may shield tiniest preemies from devastating brain bleeds
NCT ID NCT06572917
First seen Nov 01, 2025 · Last updated Jun 22, 2026 · Updated 35 times
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 indomethacin or a placebo. The goal is to find a safer, effective way to protect the smallest newborns from a life-threatening complication.
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This is a summary of
the original study
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Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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Contacts and locations
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Study contacts
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Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
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BC Women's Hospital
Vancouver, British Columbia, V6H 3N1, Canada
Contact Phone: •••-•••-•••• Email: •••••@•••••
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CHU de Quebec
Québec, Quebec, Canada
Contact Email: •••••@•••••
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Foothills Medical Center & Alberta Children's Hospital
Calgary, Alberta, Canada
Contact Email: •••••@•••••
Contact
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IWK Health
Halifax, Nova Scotia, Canada
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Kaiser Roseville
Roseville, California, 95661, United States
Contact Email: •••••@•••••
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Mercy Hospital for Women
Melbourne, Victoria, Australia
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Monash Children's Hospital
Melbourne, Victoria, Australia
Contact Email: •••••@•••••
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Montreal Children's Hospital
Montreal, Quebec, Canada
Contact Email: •••••@•••••
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Royal Alexandra Hospital
Edmonton, Alberta, Canada
Contact Email: •••••@•••••
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Royal Columbian Hospital
New Westminster, British Columbia, Canada
Contact Email: •••••@•••••
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Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
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Texas Health Harris Methodist Hospital Fort Worth
Fort Worth, Texas, 76104, United States
Contact Phone: •••-•••-••••
Contact Email: •••••@•••••
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UC Davis Health
Sacramento, California, 95817, United States
Contact Email: •••••@•••••
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University of Pittsburgh School of Medicine
Pittsburgh, Pennsylvania, 15224-1334, United States
Contact Email: •••••@•••••
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Welcome to Baylor Scott & White Health
Fort Worth, Texas, 76104, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
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 safer, simpler way to prevent severe brain bleeding in extremely preterm babies, potentially improving survival without long-term disability.
What could go wrong
This is a Phase 2 trial, so it is still early. The single dose may not be as effective as the standard 3-dose regimen, and side effects like gut injury or kidney problems remain possible.
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.