Generic Database of Moderate Preterm Infants

NCT01793116 | Completed

• 20 other identifiers: NICHD-NRN-0049U10HD021364U10HD040689U10HD021385U10HD027851U10HD027853U10HD027856U10HD027904U10HD027880U10HD034216U10HD021373U10HD040492U10HD053109U10HD040461U10HD068244U10HD068263U10HD068270U10HD068278U10HD068284U10HD036790
• Study Type: observational
• Target: 7,057
• Locations: 1 country
• Sites: 19

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.

Conditions

Infant, Newborn; Infant, Moderate Preterm

Keywords

NICHD Neonatal Research Network; Moderately Preterm

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 29 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (19)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

University of California - Los Angeles

Los Angeles, California, 90025, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

RTI International

Durham, North Carolina, 27705, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Research Institute at Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Univeristy of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Links

• NICHD Neonatal Research Network
• NICHD Pregnancy \& Perinatology Branch

Study Officials

• 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

  Children's Hospital Medical Center, Cincinnati

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 11 Weeks
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2013
• First Posted: February 15, 2013
• Study Start: March 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: February 1, 2014
• Last Updated: March 22, 2019

Record last verified: 2019-03

Locations

US (19)