Generic Data Base Study: A Registry of Very Low Birth Weight Infants - Article
Clinical Trial: Generic Data Base Study: A Registry of Very Low Birth Weight Infants
This study is currently recruiting patients.
The Generic Database is a registry of very low birth weight infants born at participating university medical centers. The goal of the database is to provide information about very low birth weight infants. The database is called the “Generic Database” because the information collected is not specific to a disease or treatment. Rather, the information can be used to study many aspects of the health and treatment of very low birth weight infants.
|Infant, very low birth weight |
MedlinePlus consumer health information
Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Retrospective/Prospective Study
Expected Total Enrollment: 35000
Study start: January 1987; Expected completion: December 2005
In 1987, the NICHD's Neonatal Research Network began enrolling infants in the Generic Database. The purpose of this project is to provide a registry of baseline and outcome data for very low birth weight infants, based on data collected from neonatal intensive care units at Network centers. Although these centers serve varying populations, they exemplify the neonatal morbidity problems of the 1980's and 1990's. The data will be used to characterize the infants admitted to these units, to examine the relationships between certain entry characteristics and outcome, and to measure trends in incidence of various diseases.
Baseline and outcome data are collected on all infants with birthweights between 401 and 1500 grams who are admitted to the Neonatal Intensive Care Units within 14 days of birth. Data are also collected on low birth weight infants who died in the delivery room. These data are obtained by review of the mother's and baby's charts. The data forms for the survey are named "generic data forms" in recognition of the fact that the information collected is of universal interest and not specific to a particular disease or treatment. They provide a summary description of the baby's background, perinatal, and neonatal experience. Outcome data collected include gestational age, birth weight, respiratory support, delivery room resuscitation, intraventricular hemorrhage, necrotizing enterocolitis, sepsis, mortality, and number of days hospitalized.
Ages Eligible for Study: up to 14 Days, Genders Eligible for Study: Both
- Birth weight of 401 to 1500 grams
- Admitted to the Neonatal Intensive Care Unit (NICU) within 14 days of age or liveborn infants who die prior to admission to the NICU
Location and Contact Information
University of Alabama at Birmingham, Birmingham, Alabama, United States; Recruiting
University of California at San Diego, San Diego, California, United States; Recruiting
Yale University, New Haven, Connecticut, United States; Recruiting
University of Miami, Miami, Florida, United States; Recruiting
Emory University, Atlanta, Georgia, United States; Recruiting
Indiana University, Indianapolis, Indiana, United States; Recruiting
Wayne State University, Detroit, Michigan, United States; Recruiting
University of Rochester, Rochester, New York, United States; Recruiting
Research Triangle Institute, Chapel Hill, North Carolina, United States; Recruiting
Duke University, Durham, North Carolina, United States; Recruiting
Wake Forest University School of Medicine, Winston Salem, North Carolina, United States; Recruiting
University of Cincinnati, Cincinnati, Ohio, United States; Recruiting
Case Western Reserve University, Cleveland, Ohio, United States; Recruiting
Women and Infants' Hospital of Rhode Island, Providence, Rhode Island, United States; Recruiting
University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States; Recruiting
The University of Texas Health Science Center at Houston, Houston, Texas, United States; Recruiting
Rosemary Higgins, M.D., Study Director, National Institute of Child Health and Human Development (NICHD)
Avroy A. Fanaroff, M.D., Principal Investigator, Case Western Reserve University
Click here for more information about the Neonatal Research Network.
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Record last reviewed: June 2003
Last Updated: October 13, 2004
Record first received: June 19, 2003
ClinicalTrials.gov Identifier: NCT00063063
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Cache Date: April 9, 2005