Timing for the Medical Treatment of Patent Ductus Arteriosus in Preterm Infants - Full Text View

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:

MedlinePlus related topics: Premature Babies

U.S. FDA Resources

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 2013
Estimated Primary Completion Date:	November 2013 (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

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:	February 8, 2013
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
Heart Defects, Congenital
Cardiovascular Abnormalities

Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 22, 2013