Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
7057 participants
OBSERVATIONAL
2012-03-31
2014-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Inborn infants and outborn infants admitted by 72 hours.
Exclusion Criteria
29 Weeks
33 Weeks
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
NICHD Neonatal Research Network
NETWORK
Responsible Party
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Principal Investigators
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Abbot R Laptook, MD
Role: PRINCIPAL_INVESTIGATOR
Brown University, Women & Infants Hospital of Rhode Island
Michele C Walsh, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University, Rainbow Babies and Children's Hospital
Ronald N Goldberg, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Barbara J Stoll, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University
Brenda B Poindexter, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Abhik Das, PhD
Role: PRINCIPAL_INVESTIGATOR
RTI International
Krisa P Van Meurs, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Kurt Schibler, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Waldemar Carlo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingha
Edward F Bell, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Kristi L Watterberg, MD
Role: PRINCIPAL_INVESTIGATOR
University of New Mexico
Pablo J Sanchez, MD
Role: PRINCIPAL_INVESTIGATOR
University of Texas, Southwestern Medical Center at Dallas
Kathleen A Kennedy, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Seetha Shankaran, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
William Truog, MD
Role: PRINCIPAL_INVESTIGATOR
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,
Barbara Schmidt, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Carl D'Angio, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Uday Devaskar, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Leif Nelin, MD
Role: PRINCIPAL_INVESTIGATOR
Research Institute at Nationwide Children's Hospital
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California - Los Angeles
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
Emory University
Atlanta, Georgia, United States
Indiana University
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Wayne State University
Detroit, Michigan, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
University of New Mexico
Albuquerque, New Mexico, United States
University of Rochester
Rochester, New York, United States
RTI International
Durham, North Carolina, United States
Duke University
Durham, North Carolina, 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
Univeristy of Pennsylvania
Philadelphia, Pennsylvania, United States
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States
University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Related Links
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NICHD Neonatal Research Network
NICHD Pregnancy \& Perinatology Branch
Other Identifiers
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NICHD-NRN-0049
Identifier Type: -
Identifier Source: org_study_id
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