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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
  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 ] [ 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.


Estimated Enrollment: 200
Study Start Date: November 2008
Estimated Study Completion Date: November 2014
Estimated 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

Ages Eligible for Study:   up to 3 Months
Genders Eligible for Study:   Both
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:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Carrie Rau, University of Utah
ClinicalTrials.gov Identifier: NCT00795990     History of Changes
Other Study ID Numbers: 31769
Study First Received: November 20, 2008
Last Updated: July 30, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2014