Generic Database of Very Low Birth Weight Infants

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00063063
Study type	Observational
Source	NICHD Neonatal Research Network
Contact	Ravi M Patal, MD
Phone	404-727-5905
Email	rmpatel@emory.edu
Status	Recruiting
Phase
Start date	January 1987
Completion date	March 31, 2030

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Generic Database of Very Low Birth Weight Infants — GDB

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms