GDB: Generic Database of Very Low Birth Weight Infants

Sponsor

NICHD Neonatal Research Network (Other)

Overall Status

Recruiting

CT.gov ID

NCT00063063

Collaborator

National Center for Research Resources (NCRR) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

80,000

Enrollment

Locations

433.9

Duration (Months)

2857.1

Patients Per Site

6.6

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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:

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 Design

Study Type:

Observational

Anticipated 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 :

Jan 1, 1987

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Outcome Measures

Primary Outcome Measures

To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner [Longitudinal database currently funded through 3/31/2021]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 14 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	University of California - Los Angeles	Los Angeles	California	United States	90025
3	Stanford University	Palo Alto	California	United States	94304
4	University of California at San Diego	San Diego	California	United States	92103-8774
5	Yale University	New Haven	Connecticut	United States	06504
6	George Washington University	Washington	District of Columbia	United States	20052
7	University of Miami	Miami	Florida	United States	33136
8	Emory University	Atlanta	Georgia	United States	30303
9	Indiana University	Indianapolis	Indiana	United States	46202
10	University of Iowa	Iowa City	Iowa	United States	52242
11	Tufts Medical Center	Boston	Massachusetts	United States	02111
12	Harvard University	Cambridge	Massachusetts	United States	02138
13	Wayne State University	Detroit	Michigan	United States	48201
14	Children's Mercy Hospital	Kansas City	Missouri	United States	64108
15	University of New Mexico	Albuquerque	New Mexico	United States	87131
16	University of Rochester	Rochester	New York	United States	14642
17	RTI International	Durham	North Carolina	United States	27705
18	Duke University	Durham	North Carolina	United States	27710
19	Cincinnati Children's Medical Center	Cincinnati	Ohio	United States	45267
20	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio	United States	44106
21	Research Institute at Nationwide Children's Hospital	Columbus	Ohio	United States	43205
22	Univeristy of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
23	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island	United States	02905
24	University of Tennessee	Memphis	Tennessee	United States	38163
25	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas	United States	75235
26	University of Texas Health Science Center at Houston	Houston	Texas	United States	77030
27	University of Utah	Salt Lake City	Utah	United States	84108
28	University of Vermont	Burlington	Vermont	United States	05405

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

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