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Managing Cyanosis Following Bidirectional Glenn Operation

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00327886
First Posted: May 19, 2006
Last Update Posted: June 13, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Children's Healthcare of Atlanta
  Purpose
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.

Condition
Congenital Disorders

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective
Official Title: A Retrospective Review of Postoperative Management of Cyanosis Following Bidirectional Glenn Operation

Further study details as provided by Children's Healthcare of Atlanta:

Estimated Enrollment: 150
Study Start Date: February 2006
Estimated Study Completion Date: February 2006
Detailed 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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Infants
  • Bidirectional Glenn operation between 1/1/03-12/31/05
  • Significant Cyanosis

Exclusion Criteria:

  • Those who do not meet inclusion criteria.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327886


Locations
United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Janet M Simsic, MD Sibley Heart Center Cardiology, Children's Healthcare of Atlanta
  More Information

ClinicalTrials.gov Identifier: NCT00327886     History of Changes
Other Study ID Numbers: 06-029
First Submitted: May 18, 2006
First Posted: May 19, 2006
Last Update Posted: June 13, 2007
Last Verified: June 2007

Keywords provided by Children's Healthcare of Atlanta:
pediatric
Glenn operation
Cyanosis

Additional relevant MeSH terms:
Cyanosis
Signs and Symptoms