Generic Database of Moderate Preterm Infants

N

NICHD Neonatal Research Network

Status

Completed

Conditions

Infant, Newborn
Infant, Moderate Preterm

Study type

Observational

Funder types

NETWORK
NIH

Identifiers

NCT01793116
U10HD053109 (U.S. NIH Grant/Contract)
U10HD021373 (U.S. NIH Grant/Contract)
U10HD027853 (U.S. NIH Grant/Contract)
U10HD068270 (U.S. NIH Grant/Contract)
U10HD021364 (U.S. NIH Grant/Contract)
U10HD027880 (U.S. NIH Grant/Contract)
U10HD036790 (U.S. NIH Grant/Contract)
U10HD027856 (U.S. NIH Grant/Contract)
NICHD-NRN-0049
U10HD040492 (U.S. NIH Grant/Contract)
U10HD027851 (U.S. NIH Grant/Contract)
U10HD068244 (U.S. NIH Grant/Contract)
U10HD040689 (U.S. NIH Grant/Contract)
U10HD068284 (U.S. NIH Grant/Contract)
U10HD068263 (U.S. NIH Grant/Contract)
U10HD034216 (U.S. NIH Grant/Contract)
U10HD021385 (U.S. NIH Grant/Contract)
U10HD027904 (U.S. NIH Grant/Contract)
U10HD068278 (U.S. NIH Grant/Contract)
U10HD040461 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a registry of moderate preterm infants, born alive at 29-33 weeks gestational age, in NICHD Neonatal Research Network (NRN) centers. The registry 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.

Full description

The Moderate Preterm Registry is a registry of moderate preterm infants (29-33 weeks gestational age) born alive in NICHD Neonatal Research Network (NRN) centers. The purpose is to collect baseline and outcome data in a uniform manner on a cohort of infants. The registry 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.

Enrollment

7,057 patients

Sex

All

Ages

29 to 33 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Gestational age 29-33 weeks
  • Inborn infants and outborn infants admitted by 72 hours.

Exclusion criteria

  • None

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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