Generic Database of Very Low Birth Weight Infants (GDB)
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|ClinicalTrials.gov Identifier: NCT00063063|
Recruitment Status : Recruiting
First Posted : June 20, 2003
Last Update Posted : March 22, 2023
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|Condition or disease|
|Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature|
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 Type :||Observational|
|Estimated Enrollment :||80000 participants|
|Official Title:||Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants|
|Study Start Date :||January 1987|
|Estimated Primary Completion Date :||March 2028|
|Estimated Study Completion Date :||March 2028|
- To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner [ Time Frame: Longitudinal database currently funded through 3/31/2021 ]
- To examine the relationship between baseline characteristics and outcome [ Time Frame: Longitudinal database currently funded through 3/31/2021 ]
- To monitor trends in incidence of various disease entities [ Time Frame: Longitudinal database currently funded through 3/31/2021 ]
- To monitor changes in VLBW and early gestational age survival [ Time Frame: Longitudinal database currently funded through 3/31/2021 ]
- To provide data for hypothesis formulation and sample size calculation for Network multi-center studies [ Time Frame: Longitudinal database currently funded through 3/31/2021 ]
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|Ages Eligible for Study:||up to 14 Days (Child)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063063
|Contact: Edward F Bell, MD||319-356-4006|
|Contact: Abhik Das, PhD||301-230-4640|
|Principal Investigator:||Abbot R Laptook, MD||Brown University, Women & Infants Hospital of Rhode Island|
|Principal Investigator:||Michele C Walsh, MD MS||Case Western Reserve University, Rainbow Babies and Children's Hospital|
|Principal Investigator:||C. Michael Cotten, MD||Duke University|
|Principal Investigator:||David P Carlton, MD||Emory University|
|Principal Investigator:||Abhik Das, PhD||RTI International|
|Principal Investigator:||Krisa P Van Meurs, MD||Stanford University|
|Principal Investigator:||Brenda Poindexter, MD MS||Children's Hospital Medical Center, Cincinnati|
|Principal Investigator:||Waldemar A Carlo, MD||University of Alabama at Birmingham|
|Study Chair:||Edward F Bell, MD||University of Iowa|
|Principal Investigator:||Kristi L Watterberg, MD||University of New Mexico|
|Principal Investigator:||Myra Wyckoff, MD||University of Texas, Southwestern Medical Center at Dallas|
|Principal Investigator:||Jon E Tyson, MD MPH||The University of Texas Health Science Center, Houston|
|Principal Investigator:||Eric Eichenwald, MD||University of Pennsylvania|
|Principal Investigator:||Carl D'Angio, MD||University of Rochester|
|Principal Investigator:||Pablo Sanchez, MD||Research Institute at Nationwide Children's Hospital|
|Principal Investigator:||Bradley Yoder, MD||University of Utah|
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)