Generic Database of Very Low Birth Weight Infants

Last updated: February 11, 2025
Sponsor: NICHD Neonatal Research Network
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

No Intervention

Clinical Study ID

NCT00063063
NICHD-NRN-0001
M01RR008084
U10HD068284
U10HD068278
UG1HD040689
M01RR000032
U10HD053089
M01RR001032
M01RR000054
M01RR000039
U10HD021415
UG1HD040492
U10HD068270
U10HD034216
M01RR000044
UG1HD112079
U10HD027904
UG1HD068278
U10HD040689
UG1HD112100
UG1HD027856
U10HD053124
U10HD053119
U10HD021385
UG1HD087226
UG1HD068263
M01RR000059
UG1HD053109
UG1HD068244
UG1HD112093
UG1HD034216
U10HD027881
U10HD040521
M01RR016587
U10HD053109
UG1HD112097
U10HD036790
UG1HD027880
U10HD040461
UG1HD087229
M01RR000070
M01RR007122
U10HD034167
UG1HD021364
U10HD021397
UL1RR025744
U10HD021364
U10HD027880
UG1HD068284
M01RR000633
U10HD027853
M01RR002635
U01HD021438
U10HD068263
UL1RR024139
U24HD095254
UG1HD053089
U10HD042638
U10HD027871
UG1HD027853
M01RR000064
M01RR000750
U01HD021466
U10HD027851
U10HD021373
UG1HD027904
M01RR000997
M01RR002172
UG1HD068270
U10HD068244
UG1HD027851
U10HD040492
M01RR000080
U01HD019897
U10HD040498
U10HD027856
  • Ages < 14
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 ortime-limited observational studies. For infants that do not meet the inclusioncriteria above, inclusion and exclusion criteria for the Generic Database aredetermined by the criteria for the additional trial(s). In these cases, infants thatare larger than 1,000 grams and/or older than 29 weeks may be included in the GDB.

Exclusion

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 Design

Total Participants: 80000
Treatment Group(s): 1
Primary Treatment: No Intervention
Phase:
Study Start date:
April 01, 1987
Estimated Completion Date:
March 31, 2030

Study 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.

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • University of California - Los Angeles

    Los Angeles, California 90025
    United States

    Completed

  • Stanford University

    Palo Alto, California 94304
    United States

    Active - Recruiting

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California 92123
    United States

    Active - Recruiting

  • University of California at San Diego

    San Diego, California 92103-8774
    United States

    Completed

  • Yale University

    New Haven, Connecticut 06504
    United States

    Completed

  • George Washington University

    Washington, District of Columbia 20052
    United States

    Completed

  • George Washington University

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

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Completed

  • Emory University

    Atlanta, Georgia 30303
    United States

    Active - Recruiting

  • Northwestern Lurie Children's Hospital of Chicago

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Completed

  • University of Iowa

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • Tufts Medical Center

    Boston, Massachusetts 02111
    United States

    Completed

  • Harvard University

    Cambridge, Massachusetts 02138
    United States

    Completed

  • Wayne State University

    Detroit, Michigan 48201
    United States

    Completed

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

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Children's Mercy Hospital

    Kansas City, Missouri 64108
    United States

    Completed

  • University of New Mexico

    Albuquerque, New Mexico 87131
    United States

    Active - Recruiting

  • University of Rochester

    Rochester, New York 14642
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • RTI International

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio 45267
    United States

    Active - Recruiting

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

    Cleveland, Ohio 44106
    United States

    Active - Recruiting

  • Research Institute at Nationwide Children's Hospital

    Columbus, Ohio 43205
    United States

    Site Not Available

  • Univeristy of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • Brown University, Women & Infants Hospital of Rhode Island

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • University of Tennessee

    Memphis, Tennessee 38163
    United States

    Completed

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas 75235
    United States

    Active - Recruiting

  • University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Active - Recruiting

  • University of Utah

    Salt Lake City, Utah 84108
    United States

    Active - Recruiting

  • University of Vermont

    Burlington, Vermont 05405
    United States

    Completed

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