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Blood transfusion showdown: can more red cells save preemie brains?

NCT ID NCT01702805

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looked at whether giving more red blood cell transfusions (liberal strategy) to extremely low birth weight babies (under 1000 grams) helps them survive without brain damage compared to a more restrictive approach. Over 1800 infants from NICUs were followed until 22-26 months of age. The goal was to see if higher hemoglobin levels improve survival and reduce neurodevelopmental problems like cerebral palsy or cognitive delays.

What this could mean

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

Active substance
Red blood cell transfusion
What this could lead to
If it works, this could help doctors decide the best transfusion strategy to improve survival and brain development in extremely premature babies.
What could go wrong
This trial is completed, but results may not apply to all hospitals or infants. Transfusions carry risks like infection or transfusion reactions.

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

1,824 people

The number who actually took part.

Started

Dec 2012

Finished

Apr 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

Up to 48 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: * Birth weight less than or equal to 1000 grams. * Gestational age at least 22 weeks but less than 29 weeks * Admitted to the NICU within 48 hours of life Exclusion Criteria: * Considered nonviable by the attending neonatologist * Cyanotic congenital heart disease * Parents opposed to the transfusion of blood * Parents with hemoglobinopathy or congenital anemia * In-utero fetal transfusion * Twin-to-twin transfusion syndrome * Isoimmune hemolytic disease * Lack of parental consent * Severe acute hemorrhage, acute shock, sepsis with coagulopathy, or need for perioperative transfusion. * Prior blood transfusion on clinical grounds beyond the first 6 hours of life * Infant has received erythropoietin prior to randomization, or is intended to receive erythropoietin through the neonatal course * Congenital condition, other than premature birth, that adversely affects life expectancy or neurodevelopment. * High probability that the family is socially disorganized to the point of being unable to attend follow-up at 22-26 months.

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Conditions

The condition(s) this trial relates to.

anemia bronchopulmonary dysplasia fetal growth restriction Infant, Newborn, Diseases perinatal disease

As listed by the trial registrant

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

Anemia Bronchopulmonary dysplasia (BPD) Infant, extremely low birth weight Infant, newborn, diseases Infant, small for gestational age

Contacts and locations

Locations

  • Brown University, Women & 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

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108, 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

  • Indiana University

    Indianapolis, Indiana, 46202, 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 California - Los Angeles

    Los Angeles, California, 90025, 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

  • Wayne State University

    Detroit, Michigan, 48201, United States

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