Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Infant, Small for Gestational Age
Conditions
Keywords
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity
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.
Interventions
OTHERNo Intervention
Sponsors
NICHD Neonatal Research Network
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner | Longitudinal database currently funded through 3/31/2030 | To maintain a registry of baseline and outcome data for VLBW infants with data collected |
Countries
United States
Contacts
CONTACTRavi M Patal, MD
CONTACTAbhik Das, PhD
PRINCIPAL_INVESTIGATORAbbot R Laptook, MD
Brown University, Women & Infants Hospital of Rhode Island
PRINCIPAL_INVESTIGATORAnna Maria Hibbs, MD, MSCE, FAAP
Case Western Reserve University, Rainbow Babies and Children's Hospital
PRINCIPAL_INVESTIGATORC. Michael Cotten, MD
Duke University
STUDY_CHAIRRavi M Patel, MD, MSc
Emory University
PRINCIPAL_INVESTIGATORAbhik Das, PhD
RTI International
PRINCIPAL_INVESTIGATORKrisa P Van Meurs, MD
Stanford University
PRINCIPAL_INVESTIGATORStephanie Merhar, MD MS
Children's Hospital Medical Center, Cincinnati
PRINCIPAL_INVESTIGATORWaldemar A Carlo, MD
University of Alabama at Birmingham
PRINCIPAL_INVESTIGATORTarah Colaizy, MD, MPH
University of Iowa
PRINCIPAL_INVESTIGATORKristi L Watterberg, MD
University of New Mexico
PRINCIPAL_INVESTIGATORMyra Wyckoff, MD
University of Texas, Southwestern Medical Center at Dallas
PRINCIPAL_INVESTIGATORJon E Tyson, MD MPH
The University of Texas Health Science Center, Houston
PRINCIPAL_INVESTIGATORSara DeMauro, MD, MSCE
University of Pennsylvania
PRINCIPAL_INVESTIGATORCarl D'Angio, MD
University of Rochester
PRINCIPAL_INVESTIGATORPablo Sanchez, MD
Research Institute at Nationwide Children's Hospital
PRINCIPAL_INVESTIGATORRobin Ohls, MD
University of Utah
Outcome results
None listed