Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a weekly shot boost brain health in preterm infants?

NCT ID NCT03169881

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 02, 2026 · Updated 2 times

Summary

This phase 3 trial tested whether giving preterm babies a drug called darbepoetin weekly could improve their brain development and reduce the need for blood transfusions. 650 infants born between 23 and 28 weeks of pregnancy were treated until they reached 35 weeks or went home. The study compared their cognitive scores at 22-26 months against a placebo group.

What this could mean

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

Active substance
Darbepoetin
What this could lead to
If it works, this could point toward a treatment that helps preterm babies have better brain development and need fewer blood transfusions.
What could go wrong
This trial is completed but results are not yet widely confirmed. The benefit may be small or not apply to all preterm infants. Risks include potential side effects from the drug.

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

650 people

The number who actually took part.

Started

Sep 2017

Finished

May 2025

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 24 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: * Inborn and outborn preterm infants * 23 0/7-28 6/7 weeks gestational age * ≤24 hours postnatal age Exclusion Criteria: * Hematocrit \> 60% * Infants with known congenital or chromosomal anomalies, including congenital heart disease and known brain anomalies * Hemorrhagic or hemolytic disease * EEG- confirmed seizures * Congenital thrombotic disease * Systolic blood pressures \>100 mm Hg while not on pressor support * Receiving Epo or Darbe clinically, or planning to receive Epo or Darbe during hospitalization * Infants in whom no aggressive therapy is planned * Family will NOT be available for follow-up at 22-26 months

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Neonatal are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

cognitive disorder

As listed by the trial registrant

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

Neonatal Neurocognitive Neurodevelopmental impairment Neuroprotective

Contacts and locations

Locations

  • Brown University - Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905, United States

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

    Cleveland, Ohio, 44106, United States

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio, 45267, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Emory University

    Atlanta, Georgia, 30303, United States

  • RTI International

    Durham, North Carolina, 27705, United States

  • Research Institute at Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • Univeristy of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75235, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

More trials for these conditions

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