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Factors Associated With Mortality in Neonates

Sponsor
Mednax Center for Research, Education, Quality and Safety (Other)
Overall Status
Completed
CT.gov ID
NCT01215461
Collaborator
(none)
645
Enrollment
1
Location
25
Duration (Months)
25.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to better understand the factors associated with mortality and identify potentially preventable causes of death in neonates who die after receiving health care. As a result, an improved neonatal mortality classification system may be defined.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    645 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Factors Associated With Mortality in Neonates
    Study Start Date :
    Sep 1, 2010
    Actual Primary Completion Date :
    Sep 1, 2012
    Actual Study Completion Date :
    Oct 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. To better understand the factors associated with mortality and identify potentially preventable causes of death in neonates who die after receiving health care. [neonatal outcomes]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Weeks to 44 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Neonates for whom healthcare was provided

    • Born alive

    • Neonate greater than or equal to 22 0/7 weeks estimated gestational age

    Exclusion Criteria:

    • Stillborn

    • Fetal demise

    • Neonates less than or equal to 21 6/7 weeks estimated gestational age

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Providence Alaska Medical Center Anchorage Alaska United States 99508

    Sponsors and Collaborators

    • Mednax Center for Research, Education, Quality and Safety

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mednax Center for Research, Education, Quality and Safety
    ClinicalTrials.gov Identifier:
    NCT01215461
    Other Study ID Numbers:
    • PDX-001-10
    First Posted:
    Oct 6, 2010
    Last Update Posted:
    May 14, 2013
    Last Verified:
    May 1, 2013
    Keywords provided by Mednax Center for Research, Education, Quality and Safety
    Neonatal mortality
    Preterm birth
    Low gestational age
    VLBW

    Study Results

    No Results Posted as of May 14, 2013