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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00795990
First Posted: November 24, 2008
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Utah
  Purpose
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
Patent Ductus Arteriosus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Early versus Late Medical Treatment of PDA [ Time Frame: 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.


Enrollment: 350
Study Start Date: November 2008
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature infants born weighing less than 1200 gms with echo confirmed PDA
Criteria

Inclusion Criteria:

  • birth weight less than 1200 gm

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00795990


Locations
United States, Utah
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
  More Information

Responsible Party: Carrie Rau, University of Utah
ClinicalTrials.gov Identifier: NCT00795990     History of Changes
Other Study ID Numbers: 31769
First Submitted: November 20, 2008
First Posted: November 24, 2008
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University of Utah:
Efficacy of early vs late use of ibuprofen for PDA closure

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities