DiGeorge SyndromeNCT00278005
Infection in DiGeorge Following CHD Surgery
An observational study of DiGeorge Syndrome and Congenital Heart Defects, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- DiGeorge Syndrome, Congenital Heart Defects
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1998to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: DiGeorge Syndrome Cardiac Surgery
Who may be able to join
- 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
Who cannot join
- Those who do not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: Incidence of Infection in the Patient With DiGeorge Syndrome Following Surgery for Congenital Heart Disease
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.
Read the 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.
- Conditions
- DiGeorge Syndrome, Congenital Heart Defects
- Keywords
- pediatric, DiGeorge Syndrome, Congenital heart defects, Infections, Cardiac surgery
- Medical subject headings
- DiGeorge Syndrome, Heart Defects, Congenital, Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2006 (estimated)
- Study startJan 1998
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiGeorge SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin O Maher, MD, Principal investigator, Children's Healthcare of Atlanta, Sibley Heart Center Cardiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00278005
- Sponsor's protocol ID
- 05-134
- Status last verified
- Mar 2008
- First submitted
- 13 Jan 2006
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Infection in the Patient With DiGeorge Syndrome Following Surgery for Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT00278005
- Acronym / sponsor ID
- 05-134
- Conditions
- DiGeorge Syndrome, Congenital Heart Defects
- Keywords
- pediatric, DiGeorge Syndrome, Congenital heart defects, Infections, Cardiac surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Jan 1998
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 18 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- DiGeorge Syndrome Cardiac Surgery
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Those who do not meet inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin O Maher, MD principal investigator
Children's Healthcare of Atlanta, Sibley Heart Center Cardiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DiGeorge Syndrome and Congenital Heart Defects, run by Children's Healthcare of Atlanta at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: completed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2012.