Generic Database of Very Low Birth Weight Infants

Recruiting

• Conditions: Infant, Small for Gestational Age; Infant, Premature; Infant, Newborn; Infant, Low Birth Weight

• Registration Number: NCT00063063
• Lead Sponsor: NICHD Neonatal Research Network

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2003-06-19
• Study First Submitted QC: 2003-06-19
• Study First Posted: 2003-06-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2030-03-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80000

Inclusion Criteria

• Infants inborn at NICHD NRN centers that are:
• 401-1000 grams birth weight, and/or
• 20 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner	Longitudinal database currently funded through 3/31/2030	To maintain a registry of baseline and outcome data for VLBW infants with data collected

Trial Locations

Locations (31)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of California - Los Angeles; 🇺🇸 Los Angeles, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

University of California at San Diego; 🇺🇸 San Diego, California, United States

Sharp Mary Birch Hospital for Women & Newborns; 🇺🇸 San Diego, California, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Northwestern Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

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