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Massive baby registry aims to unlock secrets of premature infant care

NCT ID NCT00063063

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is a large registry that collects information on very low birth weight infants (weighing 401-1000 grams or born before 29 weeks) at multiple hospitals. Researchers track the babies' health, treatments, and outcomes to find patterns and improve future care. No experimental treatment is given—it is purely observational.

What this could mean

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

What this could lead to
If successful, this registry could help doctors understand what treatments work best for very small or premature babies, leading to better care guidelines.
What could go wrong
This is an observational study, not a treatment trial. It collects data but does not test any intervention, so it cannot directly improve outcomes.

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.

Participants

About 80,000 people

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

Started

Apr 1987

Expected to finish

Mar 2030

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.

Who is studied

Infants inborn at NICHD NRN centers that are 401-1000 grams birth weight, and/or \<29 weeks gestational age, OR infants enrolled in one or more additional NICHD NRN studies.

Ages

Up to 14 days

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: * Infants inborn at NICHD NRN centers that are: * 401-1000 grams birth weight, and/or * 20 0/7 to 28 6/7 weeks (\<29 weeks) gestational age * Infants enrolled in one or more additional NICHD NRN interventional trials or time-limited observational studies. For infants that do not meet the inclusion criteria above, inclusion and exclusion criteria for the Generic Database are determined by the criteria for the additional trial(s). In these cases, infants that are larger than 1,000 grams and/or older than 29 weeks may be included in the GDB. Exclusion Criteria: * Infants \>1,000 grams birth weight and/or \>29 weeks gestational age Note: These inclusion criteria were changed as of 1/1/2008. Prior to this date, all infants with birth weights between 401 and 1500 grams who are admitted to NRN NICUs within 14 days of birth were included in the database.

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Conditions

The condition(s) this trial relates to.

fetal growth restriction Premature Birth

As listed by the trial registrant

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

Infant, low birth weight Infant, newborn Infant, premature Infant, small for gestational age

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. 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

  • Brown University, Women & Infants Hospital of Rhode Island

    ACTIVE_NOT_RECRUITING

    Providence, Rhode Island, 02905, United States

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

    RECRUITING

    Cleveland, Ohio, 44106, United States

  • Children's Mercy Hospital

    COMPLETED

    Kansas City, Missouri, 64108, 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

  • George Washington University

    COMPLETED

    Washington D.C., District of Columbia, 20052, United States

  • Harvard University

    COMPLETED

    Cambridge, Massachusetts, 02138, United States

  • Indiana University

    COMPLETED

    Indianapolis, Indiana, 46202, United States

  • Northwestern Lurie Children's Hospital of Chicago

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

  • RTI International

    ACTIVE_NOT_RECRUITING

    Durham, North Carolina, 27705, United States

  • Research Institute at Nationwide Children's Hospital

    ACTIVE_NOT_RECRUITING

    Columbus, Ohio, 43205, 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

  • Tufts Medical Center

    COMPLETED

    Boston, Massachusetts, 02111, United States

  • Univeristy of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35233, United States

  • University of California - Los Angeles

    COMPLETED

    Los Angeles, California, 90025, United States

  • University of California at San Diego

    COMPLETED

    San Diego, California, 92103-8774, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Miami

    COMPLETED

    Miami, Florida, 33136, United States

  • University of Mississippi Medical Center - Children's of Mississippi

    NOT_YET_RECRUITING

    Jackson, Mississippi, 39216, United States

  • University of New Mexico

    RECRUITING

    Albuquerque, New Mexico, 87131, United States

  • University of Rochester

    ACTIVE_NOT_RECRUITING

    Rochester, New York, 14642, United States

  • University of Tennessee

    COMPLETED

    Memphis, Tennessee, 38163, 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

  • University of Vermont

    COMPLETED

    Burlington, Vermont, 05405, United States

  • Wayne State University

    COMPLETED

    Detroit, Michigan, 48201, United States

  • Yale University

    COMPLETED

    New Haven, Connecticut, 06504, United States

More trials for these conditions

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