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One shot to save tiny brains: new trial for preemies

NCT ID NCT06572917

Prevention Sponsor: University of British Columbia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2025

An estimate. Start dates often move.

Expected to finish

Mar 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 12 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Extremely preterm infants born \<26 completed weeks of GA and/or extremely low BW infants born \<750g Exclusion Criteria: * 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

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.