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.
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
80,000
University of Alabama at Birmingham
Birmingham, Alabama, United States
RECRUITINGUniversity of California - Los Angeles
Los Angeles, California, United States
COMPLETEDStanford University
Palo Alto, California, United States
RECRUITINGUniversity of California at San Diego
San Diego, California, United States
To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner
To maintain a registry of baseline and outcome data for VLBW infants with data collected
Time frame: Longitudinal database currently funded through 3/31/2030
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Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, United States
RECRUITINGYale University
New Haven, Connecticut, United States
COMPLETEDGeorge Washington University
Washington D.C., District of Columbia, United States
COMPLETEDUniversity of Miami
Miami, Florida, United States
COMPLETEDEmory University
Atlanta, Georgia, United States
RECRUITINGNorthwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
NOT_YET_RECRUITING...and 21 more locations