Generic Database of Very Low Birth Weight Infants

This study is creating a registry, called the Generic Database (GDB), to collect information about very low birth weight (VLBW) infants. It's an observational study, meaning researchers will gather information about mothers and their infants, the treatments infants receive, and their health outcomes, without giving any specific interventions. The goal is to understand trends and connections between these factors to help plan future research. This database is currently funded through March 31, 2030. Infants can join if they are born at NICHD Neonatal Research Network (NRN) centers, weigh between 401-1000 grams, and/or are born between 20 weeks and 28 weeks 6 days of pregnancy. Infants already in other NRN studies may also be included.

Study design
This is an observational study that aims to enroll 80,000 infants. It is a registry that collects information over time.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Outcome data is collected at the time of death or discharge from the hospital.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT00063063

Generic Database of Very Low Birth Weight Infants

Recruiting
Not specifiedUp to 14Observational
NICHD Neonatal Research Network
~80,000 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:No Intervention

At a glance

Recruiting sites
13 of 31 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner
Measured over Longitudinal database currently funded through 3/31/2030
Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature

NCT00063063

Where you'd take part

This study runs at 31 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

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

    Cleveland, Ohiono site contact published

    Recruiting

  • Cincinnati Children's Medical Center

    Cincinnati, Ohiono site contact published

    Recruiting

  • Duke University

    Durham, North Carolinano site contact published

    Recruiting

  • Emory University

    Atlanta, Georgiano site contact published

    Recruiting

  • Northwestern Lurie Children's Hospital of Chicago

    Chicago, Illinoisno site contact published

    Not yet recruiting

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, Californiano site contact published

    Recruiting

  • Stanford University

    Palo Alto, Californiano site contact published

    Recruiting

  • Univeristy of Pennsylvania

    Philadelphia, Pennsylvaniano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Abbot R Laptook, MD · PRINCIPAL_INVESTIGATOR · Brown University, Women & Infants Hospital of Rhode Island
  • Anna Maria Hibbs, MD, MSCE, FAAP · PRINCIPAL_INVESTIGATOR · Case Western Reserve University, Rainbow Babies and Children's Hospital
  • C. Michael Cotten, MD · PRINCIPAL_INVESTIGATOR · Duke University
  • Ravi M Patel, MD, MSc · STUDY_CHAIR · Emory University
  • Abhik Das, PhD · PRINCIPAL_INVESTIGATOR · RTI International
  • Krisa P Van Meurs, MD · PRINCIPAL_INVESTIGATOR · Stanford University
  • Stephanie Merhar, MD MS · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati
  • Waldemar A Carlo, MD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham
  • Tarah Colaizy, MD, MPH · PRINCIPAL_INVESTIGATOR · University of Iowa
  • Kristi L Watterberg, MD · PRINCIPAL_INVESTIGATOR · University of New Mexico
  • Myra Wyckoff, MD · PRINCIPAL_INVESTIGATOR · University of Texas, Southwestern Medical Center at Dallas
  • Jon E Tyson, MD MPH · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston
  • Sara DeMauro, MD, MSCE · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
  • Carl D'Angio, MD · PRINCIPAL_INVESTIGATOR · University of Rochester
  • Pablo Sanchez, MD · PRINCIPAL_INVESTIGATOR · Research Institute at Nationwide Children's Hospital
  • Robin Ohls, MD · PRINCIPAL_INVESTIGATOR · University of Utah

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Eligibility criteria

Inclusion

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

Exclusion

Infants \>1,000 grams birth weight and/or \>29 weeks gestational age
  • To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform mannerLongitudinal database currently funded through 3/31/2030

    To maintain a registry of baseline and outcome data for VLBW infants with data collected