NCT01793116

Generic Database of Moderate Preterm Infants

Time Limited Observational Study of the Moderately Preterm Infant (29 0/7 - 33 6/7 Weeks)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7,057 (actual)
• Sponsor: NICHD Neonatal Research Network · Network
• Sex: All
• Age: 29 Weeks – 33 Weeks
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Infant, Newborn
• Infant, Moderate Preterm

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-10-01
• Completion: 2014-02-01
• First posted: 2013-02-15
• Last updated: 2019-03-22

Locations

19 sites across 1 country: United States