Generic Database of Moderate Preterm Infants

Infant, Newborn Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01793116
• Other study ID #: NICHD-NRN-0049
• Secondary ID: U10HD021364U10HD
• Status: Completed
• Start date: March 2012
• Est. completion date: February 2014

Study information

• Verified date: March 2019
• Source: NICHD Neonatal Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7057
• Est. completion date: February 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 29 Weeks to 33 Weeks

Eligibility

Inclusion Criteria:

• Gestational age 29-33 weeks

• Inborn infants and outborn infants admitted by 72 hours.

Exclusion Criteria:

Related Conditions & MeSH terms

• Infant, Moderate Preterm
• Infant, Newborn
• Premature Birth

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Cincinnati Children's Medical Center	Cincinnati	Ohio
United States	Case Western Reserve University, Rainbow Babies and Children's Hospital	Cleveland	Ohio
United States	Research Institute at Nationwide Children's Hospital	Columbus	Ohio
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	Wayne State University	Detroit	Michigan
United States	Duke University	Durham	North Carolina
United States	RTI International	Durham	North Carolina
United States	University of Texas Health Science Center at Houston	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	University of Iowa	Iowa City	Iowa
United States	Children's Mercy Hospital	Kansas City	Missouri
United States	University of California - Los Angeles	Los Angeles	California
United States	Stanford University	Palo Alto	California
United States	Univeristy of Pennsylvania	Philadelphia	Pennsylvania
United States	Brown University, Women & Infants Hospital of Rhode Island	Providence	Rhode Island
United States	University of Rochester	Rochester	New York

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of infants born moderately preterm	Number of infants born between 29-33 weeks gestational age at 18 participating NRN centers.	up to 2 years

External Links

•   NICHD Neonatal Research Network
•   NICHD Pregnancy & Perinatology Branch