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Infection in DiGeorge Following CHD Surgery

This study has been terminated.
(completed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00278005
First Posted: January 18, 2006
Last Update Posted: March 16, 2012
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 (Responsible Party):
Children's Healthcare of Atlanta
  Purpose
We propose a retrospective review of patients with DiGeorge syndrome having undergone cardiac surgery to evaluate the incidence of blood stream and/or surgical site infection. The hypothesis is that we will find an increased number of infections for this sub-group. We will compare the incidence of infection to children of similar age and diagnosis to evaluate for variances in the incidence of infection.

Condition
DiGeorge Syndrome Congenital Heart Defects

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Incidence of Infection in the Patient With DiGeorge Syndrome Following Surgery for Congenital Heart Disease

Resource links provided by NLM:


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

Enrollment: 400
Study Start Date: January 1998
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Detailed Description:
DiGeorge syndrome is a common genetic disorder that frequently results in congenital heart defects such as truncus arteriousus, coarctation of the aorta, interrupted aortic arch, tetralogy of Fallot, pulmonary atresia with VSD, and several others. The defect is usually due to a deletion in the long arm of chromosome 22. Approximately 25% of patients with DiGeorge have a congenital heart defect. These patients also have varying degrees of thymic hypoplasia with associated T cell dysfunction. They are at increased risk of infections and can be at risk for opportunistic infections when the degree of T cell dysfunction is severe. Children undergoing cardiac surgery are at risk for infections in the post-operative period, prolonging hospital stay and increasing morbidity and mortality. The patient with DiGeorge syndrome may have higher rates of infection due to associated immune system dysfunction, however, this has not been previously reported from a large group of DiGeorge syndrome patients. Children's Healthcare of Atlanta follows over 200 patients with DiGeorge syndrome, with the majority having previously undergone cardiac surgery. This group of patients may benefit from more extensive antibiotic prophylaxis following surgery if they indeed have significantly higher rates of infection, but the true incidence needs to be determined.
  Eligibility

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
DiGeorge Syndrome Cardiac Surgery
Criteria

Inclusion Criteria:

  • Children's Healthcare of Atlanta patients, Egleston DiGeorge Syndrome Cardiac Surgery 200 medical charts between Jan 1, 1998 and April 31, 2005 with cardiac surgery and DiGeorge Syndrome 200 medical charts between Jan 1, 1998 and April 31,2005 with cardiac surgery and no DiGeorge Syndrome

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): NCT00278005


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: Kevin O Maher, MD Children's Healthcare of Atlanta, Sibley Heart Center Cardiology
  More Information

Responsible Party: Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00278005     History of Changes
Other Study ID Numbers: 05-134
First Submitted: January 13, 2006
First Posted: January 18, 2006
Last Update Posted: March 16, 2012
Last Verified: March 2008

Keywords provided by Children's Healthcare of Atlanta:
pediatric
DiGeorge Syndrome
Congenital heart defects
Infections
Cardiac surgery

Additional relevant MeSH terms:
DiGeorge Syndrome
Syndrome
Infection
Heart Defects, Congenital
Disease
Pathologic Processes
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
22q11 Deletion Syndrome
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Lymphatic Abnormalities
Lymphatic Diseases
Abnormalities, Multiple
Chromosome Disorders
Genetic Diseases, Inborn
Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases