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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00795990
Other study ID # 31769
Secondary ID
Status Completed
Phase N/A
First received November 20, 2008
Last updated December 4, 2014
Start date November 2008
Est. completion date November 2014

Study information

Verified date December 2014
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 350
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group N/A to 3 Months
Eligibility Inclusion Criteria:

- birth weight less than 1200 gm

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Utah Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Early versus Late Medical Treatment of PDA 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. 1 month No
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