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Generic Database of Very Low Birth Weight Infants (GDB)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00063063
First received: June 19, 2003
Last updated: October 28, 2014
Last verified: September 2014
  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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)
Detailed Description:

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
Study Population

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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063063

Contacts
Contact: Barbara J Stoll, MD 404-727-2456
Contact: Rosemary D Higgins, MD 301-496-5575

  Show 28 Study Locations
Sponsors and Collaborators
Investigators
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: Barbara J Stoll, MD Emory University
Principal Investigator: Greg Sokol, MD 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: Myra Wyckoff, 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:
Wright LL; Papile LA. U.S. neonatal databases: methods and uses. Semin Neonatal 1997;2:159-69. (ancillary publication).

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: October 28, 2014
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 November 27, 2014