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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00795990
First received: November 20, 2008
Last updated: July 30, 2014
Last verified: July 2014

November 20, 2008
July 30, 2014
November 2008
November 2014   (final data collection date for primary outcome measure)
Early versus Late Medical Treatment of PDA [ Time Frame: 1 month ] [ Designated as safety issue: No ]
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.
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Complete list of historical versions of study NCT00795990 on ClinicalTrials.gov Archive Site
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Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants
Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Non-Probability Sample

Premature infants born weighing less than 1200 gms with echo confirmed PDA

Patent Ductus Arteriosus
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
November 2014
November 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • birth weight less than 1200 gm

Exclusion Criteria:

  • none
Both
up to 3 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00795990
31769
No
Carrie Rau, University of Utah
University of Utah
Not Provided
Principal Investigator: Gary M Chan, MD University of Utah
University of Utah
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP