Generic Database of Very Low Birth Weight Infants (GDB)
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Purpose
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.
| Condition |
|---|
|
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants |
- 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 3/31/2011 ] [ Designated as safety issue: No ]
- To examine the relationship between baseline characteristics and outcome [ Time Frame: Longitudinal database currently funded through 3/31/2011 ] [ Designated as safety issue: No ]
- To monitor trends in incidence of various disease entities [ Time Frame: Longitudinal database currently funded through 3/31/2011 ] [ Designated as safety issue: No ]
- To monitor changes in VLBW and early gestational age survival [ Time Frame: Longitudinal database currently funded through 3/31/2011 ] [ Designated as safety issue: No ]
- To provide data for hypothesis formulation and sample size calculation for Network multi-center studies [ Time Frame: Longitudinal database currently funded through 3/31/2011 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80000 |
| Study Start Date: | January 1987 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | March 2016 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | up to 14 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Infants inborn at NICHD NRN centers that are 401-1000 grams birth weight, and/or <29 weeks gestational age, OR infants enrolled in one or more additional NICHD NRN studies.
Inclusion Criteria:
- Infants inborn at NICHD NRN centers that are:
- 401-1000 grams birth weight, and/or
- 22 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.
Contacts and Locations| Contact: Barbara J Stoll, MD | (404) 727-2456 | barbara_stoll@oz.ped.emory.edu |
| Contact: Rosemary D Higgins, MD | (301) 435-7909 | higginsr@mail.nih.gov |
Show 33 Study Locations| 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: | Ronald N Goldberg, MD | Duke University |
| Principal Investigator: | Barbara J Stoll, MD | Emory University |
| Principal Investigator: | Brenda B Poindexter, MD MS | Indiana University |
| Principal Investigator: | Abhik Das, PhD | RTI International |
| Principal Investigator: | Krisa P Van Meurs, MD | Stanford University |
| Principal Investigator: | Kurt Schibler, MD | Cincinnati Children's Medical Center |
| Principal Investigator: | Waldemar A Carlo, MD | University of Alabama at Birmingham |
| Principal Investigator: | Edward F Bell, MD | University of Iowa |
| Study Director: | Kristi L Watterberg, MD | University of New Mexico |
| Principal Investigator: | Pablo J Sanchez, MD | University of Texas Southwestern Medical Center at Dallas |
| Principal Investigator: | Kathleen A Kennedy, MD MPH | The University of Texas Health Science Center, Houston |
| Principal Investigator: | Seetha Shankaran, MD | Wayne State University |
| Principal Investigator: | William Truog, MD | Children's Mercy Hospital-Kansas City, MO |
| Principal Investigator: | Barbara Schmidt, MD, MSc | University of Pennsylvania |
| Principal Investigator: | Carl D'Angio, MD | University of Rochester |
| Principal Investigator: | Uday Devaskar, MD | University of California, Los Angeles |
| Principal Investigator: | Leif Nelin, MD | Research Institute at Nationwide Children's Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| ClinicalTrials.gov Identifier: | NCT00063063 History of Changes |
| Other Study ID Numbers: | NICHD-NRN-0001, U01HD019897, U01HD021466, U10HD021364, U10HD021373, U10HD021385, U10HD021397, U10HD021415, U01HD021438, U10HD027851, U10HD027853, U10HD027856, U10HD027871, U10HD027880, U10HD027881, U10HD027904, U10HD034167, U10HD034216, U10HD036790, U10HD040461, U10HD040492, U10HD040498, U10HD040521, U10HD040689, U10HD042638, U10HD053089, U10HD053109, U10HD053119, U10HD053124, UL1RR024139, UL1RR025744, M01RR000032, M01RR000039, M01RR000044, M01RR000054, M01RR000059, M01RR000064, M01RR000070, M01RR000080, M01RR000633, M01RR000750, M01RR000997, M01RR008084, M01RR001032, M01RR002172, M01RR002635, M01RR007122, M01RR016587, U10HD068244, U10HD068263, U10HD068270, U10HD068278, U10HD068284 |
| Study First Received: | June 19, 2003 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
|
NICHD Neonatal Research Network Extremely Low Birth Weight (ELBW) Prematurity |
Additional relevant MeSH terms:
|
Birth Weight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 17, 2013