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Could less be more? new trial aims to protect preemie brains from bleeding

NCT ID NCT06676904

Disease control Sponsor: NICHD Neonatal Research Network Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether giving platelet transfusions only when levels are very low can help extremely premature babies (born at 23-26 weeks) survive without major bleeding. About 2,400 infants will be randomly assigned to a lower or higher transfusion trigger. The goal is to find the safest balance to prevent harm while avoiding unnecessary transfusions.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,433 people

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

Started

Jun 2025

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

1 hour to 48 hours

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Gestational age of 23 0/7 to 26 6/7 weeks * Postnatal age of \< 48 hours Exclusion Criteria: * Comfort care or withdrawal of care planned * Neonatal alloimmune thrombocytopenia or suspected/confirmed congenital platelet or bleeding disorder * Receipt of platelet transfusion * No receipt of Vitamin K * Parents/guardian decline consent

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Conditions

The condition(s) this trial relates to.

fetal growth restriction Infant, Newborn, Diseases perinatal disease thrombocytopenia thrombotic disease

As listed by the trial registrant

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

Infant, extremely low birth weight Infant, newborn, diseases Infant, small for gestational age Neonatal Platelet transfusion Thrombocytopenia Thrombosis

How to take part

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

  1. The places running it

    20 sites. 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

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Case Western Reserve University, Rainbow Babies and Children's Hospital

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Cincinnati Children's Medical Center

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • Nationwide Children's Hospital

    RECRUITING

    Columbus, Ohio, 43205, United States

  • Northwestern Lurie Children's Hospital of Chicago

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Pediatrix Medical Group

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Sharp Mary Birch Hospital for Women & Newborns

    RECRUITING

    San Diego, California, 92123, United States

  • Stanford University

    RECRUITING

    Palo Alto, California, 94304, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of Colorado

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of New Mexico

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Texas Southwestern Medical Center at Dallas

    RECRUITING

    Dallas, Texas, 75235, United States

  • University of Utah

    RECRUITING

    Salt Lake City, Utah, 84108, United States

  • Vanderbilt University

    RECRUITING

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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