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NCT00063063Recruiting

Generic Database of Very Low Birth Weight Infants

NICHD Neonatal Research Network

Start Date

4/1/1987

Completion Date

3/31/2030

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.

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.

Eligibility Criteria

Age Range: No minimum to No maximum

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.

Interventions

OTHER

No Intervention

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Conditions

Infant, NewbornInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, Premature

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

University of California - Los Angeles

Los Angeles, California 90025

United States

Stanford University

Palo Alto, California 94304

United States

University of California at San Diego

San Diego, California 92103-8774

United States

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California 92123

United States

Yale University

New Haven, Connecticut 06504

United States

George Washington University

Washington D.C., District of Columbia 20052

United States

University of Miami

Miami, Florida 33136

United States

Emory University

Atlanta, Georgia 30303

United States

Northwestern Lurie Children's Hospital of Chicago

Chicago, Illinois 60611

United States

Indiana University

Indianapolis, Indiana 46202

United States

University of Iowa

Iowa City, Iowa 52242

United States

Tufts Medical Center

Boston, Massachusetts 02111

United States

Harvard University

Cambridge, Massachusetts 02138

United States

Wayne State University

Detroit, Michigan 48201

United States

University of Mississippi Medical Center - Children's of Mississippi

Jackson, Mississippi 39216

United States

Children's Mercy Hospital

Kansas City, Missouri 64108

United States

University of New Mexico

Albuquerque, New Mexico 87131

United States

University of Rochester

Rochester, New York 14642

United States

RTI International

Durham, North Carolina 27705

United States

Duke University

Durham, North Carolina 27710

United States

Cincinnati Children's Medical Center

Cincinnati, Ohio 45267

United States

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

Cleveland, Ohio 44106

United States

Research Institute at Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Univeristy of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island 02905

United States

University of Tennessee

Memphis, Tennessee 38163

United States

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas 75235

United States

University of Texas Health Science Center at Houston

Houston, Texas 77030

United States

University of Utah

Salt Lake City, Utah 84108

United States

University of Vermont

Burlington, Vermont 05405

United States