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.

Study Overview

• Status: Completed
• Conditions: Infant, Newborn; Infant, Moderate Preterm

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.

• Study Type: Observational
• Enrollment (Actual): 7057

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • University of Alabama at Birmingham
  • California
    • Los Angeles, California, United States, 90025
      • University of California - Los Angeles
    • Palo Alto, California, United States, 94304
      • Stanford University
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
  • Missouri
    • Kansas City, Missouri, United States, 64108
      • Children's Mercy Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico
  • New York
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University
    • Durham, North Carolina, United States, 27705
      • RTI International
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • Cincinnati Children's Medical Center
    • Cleveland, Ohio, United States, 44106
      • Case Western Reserve University, Rainbow Babies and Children's Hospital
    • Columbus, Ohio, United States, 43205
      • Research Institute at Nationwide Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Univeristy of Pennsylvania
  • Rhode Island
    • Providence, Rhode Island, United States, 02905
      • Brown University, Women & Infants Hospital of Rhode Island
  • Texas
    • Dallas, Texas, United States, 75235
      • University of Texas Southwestern Medical Center at Dallas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 7 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NICHD Neonatal Research Network
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Investigators: Principal Investigator: Kathleen A Kennedy, MD, MPH, The University of Texas Health Science Center, Houston; Principal Investigator: Carl D'Angio, MD, University of Rochester; Principal Investigator: Barbara J Stoll, MD, Emory University; Principal Investigator: Ronald N Goldberg, MD, Duke University; Principal Investigator: Barbara Schmidt, MD, MSc, University of Pennsylvania; Principal Investigator: Michele C Walsh, MD, MS, Case Western Reserve University, Rainbow Babies and Children's Hospital; Principal Investigator: Brenda B Poindexter, MD, MS, Indiana University; Principal Investigator: Waldemar Carlo, MD, University of Alabama at Birmingha; 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,

Publications and helpful links

Helpful Links

• NICHD Neonatal Research Network
• NICHD Pregnancy & Perinatology Branch

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: February 13, 2013
• First Submitted That Met QC Criteria: February 13, 2013
• First Posted (Estimate): February 15, 2013

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: NICHD Neonatal Research Network; Moderately Preterm
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: NICHD-NRN-0049; U10HD036790 (U.S. NIH Grant/Contract); U10HD021364 (U.S. NIH Grant/Contract); U10HD021373 (U.S. NIH Grant/Contract); U10HD021385 (U.S. NIH Grant/Contract); U10HD027851 (U.S. NIH Grant/Contract); U10HD027853 (U.S. NIH Grant/Contract); U10HD027856 (U.S. NIH Grant/Contract); U10HD027880 (U.S. NIH Grant/Contract); U10HD027904 (U.S. NIH Grant/Contract); U10HD034216 (U.S. NIH Grant/Contract); U10HD040492 (U.S. NIH Grant/Contract); U10HD040689 (U.S. NIH Grant/Contract); U10HD053109 (U.S. NIH Grant/Contract); U10HD040461 (U.S. NIH Grant/Contract); U10HD068244 (U.S. NIH Grant/Contract); U10HD068263 (U.S. NIH Grant/Contract); U10HD068270 (U.S. NIH Grant/Contract); U10HD068278 (U.S. NIH Grant/Contract); U10HD068284 (U.S. NIH Grant/Contract)