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Premature baby brain drug fails in large trial

NCT ID NCT01378273

Disease control Sponsor: University of Washington 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested whether giving erythropoietin (Epo) soon after birth could reduce death or severe disability in extremely premature infants (born at 24-27 weeks). Over 900 babies were enrolled and followed until age 2. Unfortunately, Epo did not significantly lower the risk of death or severe neurodevelopmental impairment compared to placebo.

What this could mean

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

Active substance
erythropoietin (Epo)
What this could lead to
If it worked, this could reduce the risk of death or severe developmental problems in extremely premature babies.
What could go wrong
This large Phase 3 trial found no significant benefit on the primary outcome. The treatment also carries risks like blood clots and high red blood cell counts.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

941 people

The number who actually took part.

Start date

Dec 2013

Finished

Feb 2020

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

24 to 27 weeks

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: 1. NICU inpatients between 24-0/7 and 27-6/7 weeks of gestation 2. Less than twenty four hours of age 3. Parental informed consent Exclusion Criteria: 1. Major life-threatening anomalies (brain, cardiac, chromosomal anomalies) 2. Hematologic crises such as DIC, or hemolysis due to blood group incompatibilities 3. Polycythemia (hematocrit \> 65) 4. Congenital infection

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Conditions

The condition(s) this trial relates to.

Premature Birth

As listed by the trial registrant

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

Extreme prematurity

Contacts and locations

Locations

  • All Childrens Hospital

    St. Petersburg, Florida, 33701, United States

  • Beth Israel Deaconess Hospital

    Boston, Massachusetts, 02215, United States

  • Children's Hospital of Minnesota, MN

    Minneapolis, Minnesota, 55404, United States

  • Children's Hospital of Minnesota, St. Paul

    Saint Paul, Minnesota, 55102, United States

  • Children's Hospital of the University of Illinois

    Chicago, Illinois, 60612, United States

  • Florida Hospital

    Orlando, Florida, 32804, United States

  • Johns Hopkins

    Baltimore, Maryland, 21224, United States

  • Maia Fareri Children's Hospital

    Valhalla, New York, 10595, United States

  • Methodist Children's Hospital

    San Antonio, Texas, 78229, United States

  • Prentice Women's Hospital

    Chicago, Illinois, 60611, United States

  • South Miami Hospital

    Miami, Florida, 33146, United States

  • University of Arkansas

    Little Rock, Arkansas, 72202, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Minnesota Amplatz Children's Hospital

    Minneapolis, Minnesota, 55455, United States

  • University of New Mexico Children's Hospital

    Albuquerque, New Mexico, 87131, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina, 27157, United States

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