Generic Database of Very Low Birth Weight Infants

Study Overview
=================
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.

Official Title
-----------------
Generic Database: A Survey of Morbidity and Mortality in Very Low Birth Weight Infants

Conditions
-----------------
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature

Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Maximum Age: 14 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity