Generic Database of Very Low Birth Weight Infants (GDB)

  • STATUS
    Recruiting
  • End date
    Mar 6, 2023
  • participants needed
    80000
  • sponsor
    NICHD Neonatal Research Network
Updated on 22 January 2022
very low birth weight

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.

Secondary Studies include:

  1. 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.

Details
Condition Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
Clinical Study IdentifierNCT00063063
SponsorNICHD Neonatal Research Network
Last Modified on22 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Infants inborn at NICHD NRN centers that are
-1000 grams birth weight, and/or
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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