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Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants

Sponsor
University of Utah (Other)
Overall Status
Completed
CT.gov ID
NCT00795990
Collaborator
(none)
350
Enrollment
1
Location
72
Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a retrospective chart review to look at the timing of using indomethacin and ibuprofen for PDA closure for infants admitted into the NICU of the University of Utah Hospital from 1/2007-8/2008. The purpose is to compare the outcomes of medical intervention in preterm infants if intervention occurs day of life 4 or less, or day of life 5 or greater, with the birthdate being counted as day of life 1.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    This is a retrospective chart review to look at the timing of using indomethacin and ibuprofen for PDA closure for infants admitted into the NICU of the University of Utah Hospital from 1/2007-8/2008. The purpose is to compare the outcomes of medical intervention in preterm infants if intervention occurs day of life 4 or less, or day of life 5 or greater, with the birthdate being counted as day of life 1. All infants born less than 1200 gms will be evaluated for whether or not an echocardiogram was done. If an echocardiogram was done that showed a PDA, data will be collected as to what medical interventions were done, at what age, and what were the results of the medical intervention. Infants will be stratified into birthweights <800 gm and 800-1200 gm.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    350 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants
    Study Start Date :
    Nov 1, 2008
    Actual Primary Completion Date :
    Nov 1, 2014
    Actual Study Completion Date :
    Nov 1, 2014

    Outcome Measures

    Primary Outcome Measures

    1. Early versus Late Medical Treatment of PDA [1 month]

      The primary objective is to compare early (day of life 4 or less) versus late (day of life 5) medical treatment of PDA. Data will be collected via a retrospective chart review. Information will be collected on both the use of indomethacin and ibuprofen. Both medications are used as standard of care in the NICU for closure of PDAs.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 3 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • birth weight less than 1200 gm
    Exclusion Criteria:
    • none

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Utah Salt Lake City Utah United States 84108

    Sponsors and Collaborators

    • University of Utah

    Investigators

    • Principal Investigator: Gary M Chan, MD, University of Utah

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00795990
    Other Study ID Numbers:
    • 31769
    First Posted:
    Nov 24, 2008
    Last Update Posted:
    Dec 5, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by , ,
    Efficacy of early vs late use of ibuprofen for PDA closure
    Additional relevant MeSH terms:
    Ductus Arteriosus, Patent

    Study Results

    No Results Posted as of Dec 5, 2014