Generic Database of Moderate Preterm Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01793116
First received: February 13, 2013
Last updated: September 26, 2013
Last verified: August 2013

February 13, 2013
September 26, 2013
March 2012
February 2014   (final data collection date for primary outcome measure)
Number of infants born moderately preterm [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
Number of infants born between 29-33 weeks gestational age at 18 participating NRN centers.
To maintain a registry of baseline and outcome data for moderately preterm infants with data collected in a uniform manner [ Time Frame: Time limited data collection through February 2013 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01793116 on ClinicalTrials.gov Archive Site
Not Provided
  • To examine the relationship between baseline characteristics and outcome [ Time Frame: Time limited data collection through February 2013 ] [ Designated as safety issue: No ]
  • To provide data for hypothesis formulation and sample size calculation for Network multi-center studies [ Time Frame: Time limited data collection through February 2013 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Generic Database of Moderate Preterm Infants
Time Limited Observational Study of the Moderately Preterm Infant (29 0/7 - 33 6/7 Weeks)

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.

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.

Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
11 Weeks
Not Provided
Non-Probability Sample

Moderately preterm infants born at 29 0/7 weeks to 33 6/7 weeks—both inborn and outborn but admitted prior to 72 hours at NRN centers will be included in this study.

  • Infant, Newborn
  • Infant, Moderate Preterm
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6000
July 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Both
29 Weeks to 33 Weeks
Yes
Contact: Michele C Walsh, MD, MS 216-844-3759
Contact: Rosemary D Higgins, MD 301-496-5575
United States
 
NCT01793116
NICHD-NRN-0049, U10HD021364, U10HD040689, U10HD021385, U10HD027851, U10HD027853, U10HD027856, U10HD027904, U10HD027880, U10HD034216, U10HD021373, U10HD040492, U10HD053109, U10HD040461, U10HD068244, U10HD068263, U10HD068270, U10HD068278, U10HD068284, U10HD036790
No
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Center for Research Resources (NCRR)
Principal Investigator: Abbot R Laptook, MD Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator: Michele C Walsh, MD, MS Case Western Reserve University, Rainbow Babies and Children's Hospital
Principal Investigator: Ronald N Goldberg, MD Duke University
Principal Investigator: Barbara J Stoll, MD Emory University
Principal Investigator: Brenda B Poindexter, MD, MS Indiana University
Principal Investigator: Abhik Das, PhD RTI International
Principal Investigator: Krisa P Van Meurs, MD Stanford University
Principal Investigator: Kurt Schibler, MD Cincinnati Children's Medical Center
Principal Investigator: Waldemar Carlo, MD University of Alabama at Birmingha
Principal Investigator: Edward F Bell, MD University of Iowa
Principal Investigator: Kristi L Watterberg, MD University of New Mexico
Principal Investigator: Pablo J Sanchez, MD University of Texas Southwestern Medical Center at Dallas
Principal Investigator: Kathleen A Kennedy, MD, MPH The University of Texas Health Science Center, Houston
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: William Truog, MD Abbot R Laptook, MD Study Principal Investigator Brown University, Women & Infants Hospital of Rhode Island Michele C Walsh, MD MS Study Principal Investigator Case Western Reserve University, Rainbow Babies and Children's Hospital Ronald N Goldberg,
Principal Investigator: Barbara Schmidt, MD, MSc University of Pennsylvania
Principal Investigator: Carl D'Angio, MD University of Rochester
Principal Investigator: Uday Devaskar, MD University of California, Los Angeles
Principal Investigator: Leif Nelin, MD Research Institute at Nationwide Children's Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP