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Clinical Trial Summary

The purpose of this retrospective study is to review the postoperative medical management of infants who underwent bidirectional Glenn operation from January 1, 2003 to December 31, 2005 who were significantly cyanotic.


Clinical Trial Description

Infants following bidirectional Glenn operation are at times significantly cyanotic. The medical management of significant postoperative cyanosis has changed with the advent of nitric oxide, sildenafil and bosentan. The purpose of this retrospective study is to review the postoperative medical management of infants who underwent bidirectional Glenn operation from Jan 1, 2003 to Dec 31, 2005 who were significantly cyanotic.

Summary of Procedures This is a retrospective study, therefore, the only procedure will be a chart review. I estimate the number of patients to be around 150, however, request permission to review the patient population in order to provide exact numbers. We request permission to review hospital charts from the time of bidirectional Glenn operation and the last clinic note within the dates Jan 1, 2003 to Dec 31, 2005.

We will assign each chart a unique study number and collect data of:

date of follow-up oxygen saturation during stay time since discharge 02 saturation at home home medications when discontinue medications ;


Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Related Conditions & MeSH terms


NCT number NCT00327886
Study type Observational
Source Children's Healthcare of Atlanta
Contact
Status Terminated
Phase N/A
Start date February 2006
Completion date February 2006

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