Generic Database of Very Low Birth Weight Infants

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 22 0/7 - 28 6/7 weeks' gestation and its associated
factors at Network sites.

Inclusion Criteria:

- Infants inborn at NICHD NRN centers that are:

- 401-1000 grams birth weight, and/or

- 22 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.