Generic Database of Very Low Birth Weight Infants
- Conditions
- Infant, Small for Gestational AgeInfant, PrematureInfant, NewbornInfant, 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80000
- 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.
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (31)
Emory University
🇺🇸Atlanta, Georgia, United States
Harvard University
🇺🇸Cambridge, Massachusetts, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Brown University, Women & Infants Hospital of Rhode Island
🇺🇸Providence, Rhode Island, United States
University of Mississippi Medical Center - Children's of Mississippi
🇺🇸Jackson, Mississippi, United States
University of Vermont
🇺🇸Burlington, Vermont, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
🇺🇸Cleveland, Ohio, United States
University of Miami
🇺🇸Miami, Florida, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of California - Los Angeles
🇺🇸Los Angeles, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
George Washington University
🇺🇸Washington, District of Columbia, United States
Northwestern Lurie Children's Hospital of Chicago
🇺🇸Chicago, Illinois, United States
Research Institute at Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Univeristy of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Tennessee
🇺🇸Memphis, Tennessee, 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
Cincinnati Children's Medical Center
🇺🇸Cincinnati, Ohio, United States
RTI International
🇺🇸Durham, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Yale University
🇺🇸New Haven, Connecticut, United States
University of Rochester
🇺🇸Rochester, New York, United States