We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Generic Database of Very Low Birth Weight Infants (GDB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00063063
Recruitment Status : Recruiting
First Posted : June 20, 2003
Last Update Posted : March 23, 2023
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
NICHD Neonatal Research Network

Brief Summary:
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 or disease
Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature

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.

Secondary Studies include:

A. The All Birth Cohort (ABC) Study. A time-limited observational registry to determine the incidence of intrapartum stillbirth at 20 0/7 - 28 6/7 weeks' gestation and its associated factors at Network sites.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 80000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants
Study Start Date : January 1987
Estimated Primary Completion Date : March 2030
Estimated Study Completion Date : March 2030

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 3/31/2021 ]

Secondary Outcome Measures :
  1. To examine the relationship between baseline characteristics and outcome [ Time Frame: Longitudinal database currently funded through 3/31/2021 ]
  2. To monitor trends in incidence of various disease entities [ Time Frame: Longitudinal database currently funded through 3/31/2021 ]
  3. To monitor changes in VLBW and early gestational age survival [ Time Frame: Longitudinal database currently funded through 3/31/2021 ]
  4. To provide data for hypothesis formulation and sample size calculation for Network multi-center studies [ Time Frame: Longitudinal database currently funded through 3/31/2021 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
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
  • 20 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00063063


Contacts
Layout table for location contacts
Contact: Edward F Bell, MD 319-356-4006
Contact: Abhik Das, PhD 301-230-4640

Locations
Show Show 28 study locations
Sponsors and Collaborators
NICHD Neonatal Research Network
National Center for Research Resources (NCRR)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
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: David P Carlton, MD Emory University
Principal Investigator: Abhik Das, PhD RTI International
Principal Investigator: Krisa P Van Meurs, MD Stanford University
Principal Investigator: Brenda Poindexter, MD MS Children's Hospital Medical Center, Cincinnati
Principal Investigator: Waldemar A Carlo, MD University of Alabama at Birmingham
Study Chair: Edward F Bell, MD University of Iowa
Principal Investigator: Kristi L Watterberg, MD University of New Mexico
Principal Investigator: Myra Wyckoff, MD University of Texas, Southwestern Medical Center at Dallas
Principal Investigator: Jon E Tyson, MD MPH The University of Texas Health Science Center, Houston
Principal Investigator: Eric Eichenwald, MD University of Pennsylvania
Principal Investigator: Carl D'Angio, MD University of Rochester
Principal Investigator: Pablo Sanchez, MD Research Institute at Nationwide Children's Hospital
Principal Investigator: Bradley Yoder, MD University of Utah
Additional Information:
Publications of Results:
Wright LL; Papile LA. U.S. neonatal databases: methods and uses. Semin Neonatal 1997;2:159-69. (ancillary publication).

Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: NICHD Neonatal Research Network
ClinicalTrials.gov Identifier: NCT00063063    
Other Study ID Numbers: NICHD-NRN-0001
U01HD019897 ( U.S. NIH Grant/Contract )
U01HD021466 ( U.S. NIH Grant/Contract )
U10HD021364 ( U.S. NIH Grant/Contract )
U10HD021373 ( U.S. NIH Grant/Contract )
U10HD021385 ( U.S. NIH Grant/Contract )
U10HD021397 ( U.S. NIH Grant/Contract )
U10HD021415 ( U.S. NIH Grant/Contract )
U01HD021438 ( U.S. NIH Grant/Contract )
U10HD027851 ( U.S. NIH Grant/Contract )
U10HD027853 ( U.S. NIH Grant/Contract )
U10HD027856 ( U.S. NIH Grant/Contract )
U10HD027871 ( U.S. NIH Grant/Contract )
U10HD027880 ( U.S. NIH Grant/Contract )
U10HD027881 ( U.S. NIH Grant/Contract )
U10HD027904 ( U.S. NIH Grant/Contract )
U10HD034167 ( U.S. NIH Grant/Contract )
U10HD034216 ( U.S. NIH Grant/Contract )
U10HD036790 ( U.S. NIH Grant/Contract )
U10HD040461 ( U.S. NIH Grant/Contract )
U10HD040492 ( U.S. NIH Grant/Contract )
U10HD040498 ( U.S. NIH Grant/Contract )
U10HD040521 ( U.S. NIH Grant/Contract )
U10HD040689 ( U.S. NIH Grant/Contract )
U10HD042638 ( U.S. NIH Grant/Contract )
U10HD053089 ( U.S. NIH Grant/Contract )
U10HD053109 ( U.S. NIH Grant/Contract )
U10HD053119 ( U.S. NIH Grant/Contract )
U10HD053124 ( U.S. NIH Grant/Contract )
UL1RR024139 ( U.S. NIH Grant/Contract )
UL1RR025744 ( U.S. NIH Grant/Contract )
M01RR000032 ( U.S. NIH Grant/Contract )
M01RR000039 ( U.S. NIH Grant/Contract )
M01RR000044 ( U.S. NIH Grant/Contract )
M01RR000054 ( U.S. NIH Grant/Contract )
M01RR000059 ( U.S. NIH Grant/Contract )
M01RR000064 ( U.S. NIH Grant/Contract )
M01RR000070 ( U.S. NIH Grant/Contract )
M01RR000080 ( U.S. NIH Grant/Contract )
M01RR000633 ( U.S. NIH Grant/Contract )
M01RR000750 ( U.S. NIH Grant/Contract )
M01RR000997 ( U.S. NIH Grant/Contract )
M01RR008084 ( U.S. NIH Grant/Contract )
M01RR001032 ( U.S. NIH Grant/Contract )
M01RR002172 ( U.S. NIH Grant/Contract )
M01RR002635 ( U.S. NIH Grant/Contract )
M01RR007122 ( U.S. NIH Grant/Contract )
M01RR016587 ( U.S. NIH Grant/Contract )
U10HD068244 ( U.S. NIH Grant/Contract )
U10HD068263 ( U.S. NIH Grant/Contract )
U10HD068270 ( U.S. NIH Grant/Contract )
U10HD068278 ( U.S. NIH Grant/Contract )
U10HD068284 ( U.S. NIH Grant/Contract )
UG1HD034216 ( U.S. NIH Grant/Contract )
UG1HD027904 ( U.S. NIH Grant/Contract )
UG1HD021364 ( U.S. NIH Grant/Contract )
UG1HD027853 ( U.S. NIH Grant/Contract )
UG1HD040689 ( U.S. NIH Grant/Contract )
UG1HD040492 ( U.S. NIH Grant/Contract )
UG1HD027851 ( U.S. NIH Grant/Contract )
UG1HD087229 ( U.S. NIH Grant/Contract )
UG1HD027856 ( U.S. NIH Grant/Contract )
UG1HD053109 ( U.S. NIH Grant/Contract )
UG1HD068284 ( U.S. NIH Grant/Contract )
UG1HD068278 ( U.S. NIH Grant/Contract )
UG1HD068244 ( U.S. NIH Grant/Contract )
UG1HD068263 ( U.S. NIH Grant/Contract )
UG1HD027880 ( U.S. NIH Grant/Contract )
UG1HD068270 ( U.S. NIH Grant/Contract )
UG1HD053089 ( U.S. NIH Grant/Contract )
UG1HD087226 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2003    Key Record Dates
Last Update Posted: March 23, 2023
Last Verified: March 2023
Keywords provided by NICHD Neonatal Research Network:
NICHD Neonatal Research Network
Extremely Low Birth Weight (ELBW)
Prematurity
Additional relevant MeSH terms:
Layout table for MeSH terms
Body Weight
Birth Weight