Generic Database of Very Low Birth Weight Infants — GDB  

Infant, Premature Clinical Trial

Official title: Generic Database: A Survey of Morbidity and Mortality in 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. ;

Related Conditions & MeSH terms

• Birth Weight
• Body Weight
• Infant, Low Birth Weight
• Infant, Newborn
• Infant, Premature
• Infant, Small for Gestational Age

• 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
• Start date: January 1987
• Completion date: March 31, 2030