Clinical Trial: Generic Data Base Study: A Registry of Very Low Birth Weight Infants

This study is currently recruiting patients.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)

Purpose

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

MedlinePlus consumer health information 

Study Type: Observational
Study Design: Screening, Longitudinal, Defined Population, Retrospective/Prospective Study

Official Title: The Generic Data Base (GDB) Study: Survey of Morbidity and Mortality in Very Low Birth Weight Infants

Further Study Details: 

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.

Eligibility

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

Location and Contact Information

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

Alabama
      University of Alabama at Birmingham, Birmingham,  Alabama,  United States; Recruiting
Waldemar A. Carlo, M.D.,  Principal Investigator

California
      University of California at San Diego, San Diego,  California,  United States; Recruiting
Neil N. Finer, M.D.,  Principal Investigator

Connecticut
      Yale University, New Haven,  Connecticut,  United States; Recruiting
Richard A. Ehrenkranz, M.D.,  Principal Investigator

Florida
      University of Miami, Miami,  Florida,  United States; Recruiting
Shahnaz Duara, M.D.,  Principal Investigator

Georgia
      Emory University, Atlanta,  Georgia,  United States; Recruiting
Barbara J. Stoll, M.D.,  Principal Investigator

Indiana
      Indiana University, Indianapolis,  Indiana,  United States; Recruiting
James A. Lemons, M.D.,  Principal Investigator

Michigan
      Wayne State University, Detroit,  Michigan,  United States; Recruiting
Seetha Shankaran, M.D.,  Principal Investigator

New York
      University of Rochester, Rochester,  New York,  United States; Recruiting
Dale L. Phelps, M.D.,  Principal Investigator

North Carolina
      Research Triangle Institute, Chapel Hill,  North Carolina,  United States; Recruiting
Kenneth Poole, Ph.D.,  Principal Investigator

      Duke University, Durham,  North Carolina,  United States; Recruiting
Ronald N. Goldberg, M.D.,  Principal Investigator

      Wake Forest University School of Medicine, Winston Salem,  North Carolina,  United States; Recruiting
T. Michael O'Shea, M.D.,  Principal Investigator

Ohio
      University of Cincinnati, Cincinnati,  Ohio,  United States; Recruiting
Edward F. Donovan, M.D.,  Principal Investigator

      Case Western Reserve University, Cleveland,  Ohio,  United States; Recruiting
Avroy A. Fanaroff, M.D.,  Principal Investigator

Rhode Island
      Women and Infants' Hospital of Rhode Island, Providence,  Rhode Island,  United States; Recruiting
William Oh, M.D.,  Principal Investigator

Texas
      University of Texas Southwestern Medical Center at Dallas, Dallas,  Texas,  United States; Recruiting
Abbot R. Laptook, M.D.,  Principal Investigator

      The University of Texas Health Science Center at Houston, Houston,  Texas,  United States; Recruiting
Jon E. Tyson, M.D.,  Principal Investigator

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   

More Information

Click here for more information about the Neonatal Research Network.

Publications

Hack M, Horbar JD, Malloy MH, Tyson JE, Wright E, Wright L. Very low birth weight outcomes of the National Institute of Child Health and Human Development Neonatal Network. Pediatrics. 1991 May;87(5):587-97.

Hack M, Wright LL, Shankaran S, Tyson JE, Horbar JD, Bauer CR, Younes N. Very-low-birth-weight outcomes of the National Institute of Child Health and Human Development Neonatal Network, November 1989 to October 1990. Am J Obstet Gynecol. 1995 Feb;172(2 Pt 1):457-64. Erratum in: Am J Obstet Gynecol 1995 Sep;173(3 Pt 1):961.

Fanaroff AA, Wright LL, Stevenson DK, Shankaran S, Donovan EF, Ehrenkranz RA, Younes N, Korones SB, Stoll BJ, Tyson JE, et al. Very-low-birth-weight outcomes of the National Institute of Child Health and Human Development Neonatal Research Network, May 1991 through December 1992. Am J Obstet Gynecol. 1995 Nov;173(5):1423-31.

Stevenson DK, Wright LL, Lemons JA, Oh W, Korones SB, Papile LA, Bauer CR, Stoll BJ, Tyson JE, Shankaran S, Fanaroff AA, Donovan EF, Ehrenkranz RA, Verter J. Very low birth weight outcomes of the National Institute of Child Health and Human Development Neonatal Research Network, January 1993 through December 1994. Am J Obstet Gynecol. 1998 Dec;179(6 Pt 1):1632-9.

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


Source: ClinicalTrials.gov
Cache Date: April 9, 2005