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Generic Database of Very Low Birth Weight Infants

2014-08-27 03:55:08 | BioPortfolio

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.

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Conditions

Infant, Newborn

Location

University of Alabama at Birmingham
Birmingham
Alabama
United States
35233

Status

Recruiting

Source

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:55:08-0400

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Medical and Biotech [MESH] Definitions

The event that a FETUS is born alive with heartbeats or RESPIRATION regardless of GESTATIONAL AGE. Such liveborn is called a newborn infant (INFANT, NEWBORN).

An infant during the first month after birth.

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The identification of selected parameters in newborn infants by various tests, examinations, or other procedures. Screening may be performed by clinical or laboratory measures. A screening test is designed to sort out healthy neonates (INFANT, NEWBORN) from those not well, but the screening test is not intended as a diagnostic device, rather instead as epidemiologic.

A subspecialty of Pediatrics concerned with the newborn infant.

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