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Generic Database of Very Low Birth Weight Infants (GDB)

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ClinicalTrials.gov Identifier: NCT00063063
Recruitment Status : Recruiting
First Posted : June 20, 2003
Last Update Posted : January 21, 2020
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

Tracking Information
First Submitted Date June 19, 2003
First Posted Date June 20, 2003
Last Update Posted Date January 21, 2020
Study Start Date January 1987
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 18, 2019)
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 ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: June 18, 2019)
  • To examine the relationship between baseline characteristics and outcome [ Time Frame: Longitudinal database currently funded through 3/31/2021 ]
  • To monitor trends in incidence of various disease entities [ Time Frame: Longitudinal database currently funded through 3/31/2021 ]
  • To monitor changes in VLBW and early gestational age survival [ Time Frame: Longitudinal database currently funded through 3/31/2021 ]
  • 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 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Generic Database of Very Low Birth Weight Infants
Official Title Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 14, 2013)
80000
Original Enrollment
 (submitted: June 23, 2005)
35000
Estimated Study Completion Date March 2021
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: All
Ages up to 14 Days   (Child)
Accepts Healthy Volunteers No
Contacts
Contact: Edward F Bell, MD 319-356-4006
Contact: Abhik Das, PhD 301-230-4640
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number 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 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party NICHD Neonatal Research Network
Study Sponsor NICHD Neonatal Research Network
Collaborators
  • National Center for Research Resources (NCRR)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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: 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
PRS Account NICHD Neonatal Research Network
Verification Date January 2020