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Generic Database of Moderate Preterm Infants

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01793116
Enrollment
7057
Registered
2013-02-15
Start date
2012-03-31
Completion date
2014-02-28
Last updated
2019-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Moderate Preterm, Infant, Newborn

Keywords

NICHD Neonatal Research Network, Moderately Preterm

Brief 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.

Interventions

None listed

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
NICHD Neonatal Research Network
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
29 Weeks to 33 Weeks
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Number of infants born moderately pretermup to 2 yearsNumber of infants born between 29-33 weeks gestational age at 18 participating NRN centers.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026