Generic Database of Very Low Birth Weight Infants (GDB)

March 12, 2026 updated by: NICHD Neonatal Research Network

Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The purpose is to collect baseline and outcome data in a uniform manner on a large cohort of VLBW and other sick infants admitted to neonatal intensive care units.

The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Baseline data is collected soon after admission to the NICU; outcome data is collected at the time of death or discharge from the hospital. The data collected includes information on:

  • Demographics of mother and infant
  • Mother's health (e.g., pregnancy history and complications)
  • Labor and deliver (e.g., rupture of the membranes, steroids and antibiotics given, mode of delivery)
  • Infant's health (gestational age, Apgar scores, weight, length, delivery room resuscitation, respiratory support, etc.)
  • Infant's medical outcome (heart, lung, nervous system, gastrointestinal system, hearing, and vision, known infections, and major malformations/syndromes, and mortality or number of days hospitalized).

These data are used: to examine associations between baseline characteristics, treatments, and outcomes; to track trends in incidences of disease and effectiveness of therapies; and to identify questions requiring additional in-depth research.

Informed Consent: As required by local IRBs.

Secondary Studies include:

A. The All Birth Cohort (ABC) Study. A time-limited observational registry to determine the incidence of intrapartum stillbirth at 20 0/7 - 28 6/7 weeks' gestation and its associated factors at Network sites.

Study Type

Observational

Enrollment (Estimated)

80000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Abhik Das, PhD
  • Phone Number: 301-230-4640
  • Email: adas@rti.org

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Waldemar A. Carlo, MD
        • Principal Investigator:
          • Waldemar A. Carlo, MD
    • California
      • Los Angeles, California, United States, 90025
        • Completed
        • University of California - Los Angeles
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Contact:
          • Krisa P. Van Meurs, MD
        • Principal Investigator:
          • Krisa P. Van Meurs, MD
      • San Diego, California, United States, 92103-8774
        • Completed
        • University of California at San Diego
      • San Diego, California, United States, 92123
        • Recruiting
        • Sharp Mary Birch Hospital for Women & Newborns
        • Contact:
          • Anup Katheria, MD
        • Principal Investigator:
          • Anup Katheria, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06504
        • Completed
        • Yale University
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20052
        • Completed
        • George Washington University
    • Florida
      • Miami, Florida, United States, 33136
        • Completed
        • University of Miami
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Emory University
        • Contact:
          • David P Carlton, MD
        • Principal Investigator:
          • David P Carlton, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Not yet recruiting
        • Northwestern Lurie Children's Hospital of Chicago
        • Contact:
          • Aaron Hamvas, MD
        • Principal Investigator:
          • Aaron Hamvas, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Completed
        • Indiana University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa
        • Contact:
          • Edward F. Bell, MD
        • Principal Investigator:
          • Edward F. Bell, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Completed
        • Tufts Medical Center
      • Cambridge, Massachusetts, United States, 02138
        • Completed
        • Harvard University
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Completed
        • Wayne State University
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Not yet recruiting
        • University of Mississippi Medical Center - Children's of Mississippi
        • Principal Investigator:
          • Abhay Bhatt, MD
        • Contact:
          • Abhay Bhatt, MD
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Completed
        • Children's Mercy Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • University of New Mexico
        • Contact:
          • Kristi L. Watterberg, MD
        • Principal Investigator:
          • Kristi L. Watterberg, MD
    • New York
      • Rochester, New York, United States, 14642
        • Active, not recruiting
        • University of Rochester
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Contact:
          • C. Michael Cotten, MD, MHS
        • Principal Investigator:
          • C. Michael Cotten, MD, MHS
      • Durham, North Carolina, United States, 27705
        • Active, not recruiting
        • RTI International
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • Cincinnati Children's Medical Center
        • Contact:
          • Brenda Poindexter, MD MS
        • Principal Investigator:
          • Brenda Poindexter, MD MS
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Case Western Reserve University, Rainbow Babies and Children's Hospital
        • Contact:
          • Michele C. Walsh, MD MS
        • Principal Investigator:
          • Michele C. Walsh, MD MS
      • Columbus, Ohio, United States, 43205
        • Active, not recruiting
        • Research Institute at Nationwide Children's Hospital
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Univeristy of Pennsylvania
        • Contact:
          • Eric Eichenwald, MD
        • Principal Investigator:
          • Eric Eichenwald, MD
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Active, not recruiting
        • Brown University, Women & Infants Hospital of Rhode Island
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • Completed
        • University of Tennessee
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • University of Texas Southwestern Medical Center at Dallas
        • Contact:
          • Myra H Wyckoff, MD
        • Principal Investigator:
          • Myra H Wyckoff, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas Health Science Center at Houston
        • Contact:
          • Jon E. Tyson, MD MPH
        • Principal Investigator:
          • Jon E. Tyson, MD MPH
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah
        • Contact:
          • Bradley Yoder, MD
        • Principal Investigator:
          • Bradley Yoder, MD
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Completed
        • University of Vermont

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 weeks (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Registry Cohort
Other: No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner
Time Frame: Longitudinal database currently funded through 3/31/2030
To maintain a registry of baseline and outcome data for VLBW infants with data collected
Longitudinal database currently funded through 3/31/2030

Secondary Outcome Measures

Outcome Measure
Time Frame
To examine the relationship between baseline characteristics and outcome
Time Frame: Longitudinal database currently funded through 3/31/2021
Longitudinal database currently funded through 3/31/2021
To monitor trends in incidence of various disease entities
Time Frame: Longitudinal database currently funded through 3/31/2021
Longitudinal database currently funded through 3/31/2021
To monitor changes in VLBW and early gestational age survival
Time Frame: Longitudinal database currently funded through 3/31/2021
Longitudinal database currently funded through 3/31/2021
To provide data for hypothesis formulation and sample size calculation for Network multi-center studies
Time Frame: Longitudinal database currently funded through 3/31/2021
Longitudinal database currently funded through 3/31/2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NICHD Neonatal Research Network

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 1987

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

June 19, 2003

First Submitted That Met QC Criteria

June 19, 2003

First Posted (Estimated)

June 20, 2003

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NICHD-NRN-0001
  • UG1HD034216 (U.S. NIH Grant/Contract)
  • UG1HD027904 (U.S. NIH Grant/Contract)
  • UG1HD021364 (U.S. NIH Grant/Contract)
  • UG1HD027853 (U.S. NIH Grant/Contract)
  • UG1HD040689 (U.S. NIH Grant/Contract)
  • UG1HD040492 (U.S. NIH Grant/Contract)
  • UG1HD027851 (U.S. NIH Grant/Contract)
  • UG1HD053109 (U.S. NIH Grant/Contract)
  • UG1HD068278 (U.S. NIH Grant/Contract)
  • UG1HD068244 (U.S. NIH Grant/Contract)
  • UG1HD068263 (U.S. NIH Grant/Contract)
  • UG1HD027880 (U.S. NIH Grant/Contract)
  • UG1HD053089 (U.S. NIH Grant/Contract)
  • UG1HD087226 (U.S. NIH Grant/Contract)
  • UG1HD112079 (U.S. NIH Grant/Contract)
  • UG1HD112097 (U.S. NIH Grant/Contract)
  • UG1HD112100 (U.S. NIH Grant/Contract)
  • U24HD095254 (U.S. NIH Grant/Contract)
  • UG1HD112093 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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