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.

Condition
Infant, very low birth weight

Further Study Details: 

Expected Total Enrollment:  35000

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

Criteria

Inclusion Criteria

• 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

Kenneth Poole, Ph.D.       poo@rti.org

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  United States; Recruiting
California
      University of California at San Diego, San Diego,  California,  United States; Recruiting
Connecticut
      Yale University, New Haven,  Connecticut,  United States; Recruiting
Florida
      University of Miami, Miami,  Florida,  United States; Recruiting
Georgia
      Emory University, Atlanta,  Georgia,  United States; Recruiting
Indiana
      Indiana University, Indianapolis,  Indiana,  United States; Recruiting
Michigan
      Wayne State University, Detroit,  Michigan,  United States; Recruiting
New York
      University of Rochester, Rochester,  New York,  United States; Recruiting
North Carolina
      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
Ohio
      University of Cincinnati, Cincinnati,  Ohio,  United States; Recruiting
      Case Western Reserve University, Cleveland,  Ohio,  United States; Recruiting
Rhode Island
      Women and Infants' Hospital of Rhode Island, Providence,  Rhode Island,  United States; Recruiting
Texas
      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

Study chairs or principal investigators

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   

Study ID Numbers:  NICHD-GDB; U10 HD21397; U10 HD34216; U10 HD27853; U10 HD27871; U10 HD21364; U10 HD40461; U10 HD40492; U10 HD21415; U10 HD40689; U10 HD27856; U10 HD27904; U10 HD40498; U10 HD27881; U10 HD40521; U01 HD36790; U10 HD21385; U10 HD34167; U10 HD27880; U10 HD27851; U10 HD21373; U01 HD19897
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