- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00779662
The Prevalence of Rheumatic Heart Disease in School Children in Fiji
October 23, 2008 updated by: Queensland Institute of Medical Research
This study is an epidemiological observational cross-sectional study designed to estimate the prevalence of echocardiographically confirmed RHD in school children from 5-14 years of age in Fiji.
The study will be conducted in the Central Division of Fiji within a selection of up to16 primary schools located in the Korovou/Tailevu and Rewa/Nausori sub-divisions.
School children will be enrolled after informed consent has been obtained.
A standard cardiac examination (auscultation) will be performed as part of the routine annual health check by both school nurses, who have attended a training workshop, and by a paediatrician.
All children with or without murmur will have a screening echocardiogram performed at a subsequent visit.
Children found to have possible, probable or definite RHD or other cardiac pathology on the screening echocardiogram, will have a full echocardiogram performed by the echocardiography technician at the time of the second study visit.
They will all also be referred to a paediatric cardiologist for further investigation and management and monitoring .
Cases of RHD will be referred to and followed up by the National Fiji RHD register based at CWMH in Suva.
Study Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
2000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 14 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study will be conducted in the Central Division of Fiji within a selection of up to16 primary schools located in the Korovou/Tailevu and Rewa/Nausori sub-divisions.
Description
Inclusion Criteria:
- Informed consent will be obtained for all participants
- All children between the ages of 5-14 Years are eligible for the study.
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2008
Primary Completion (ANTICIPATED)
December 1, 2008
Study Completion (ANTICIPATED)
December 1, 2008
Study Registration Dates
First Submitted
October 23, 2008
First Submitted That Met QC Criteria
October 23, 2008
First Posted (ESTIMATE)
October 24, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
October 24, 2008
Last Update Submitted That Met QC Criteria
October 23, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07- 0070
- U01AI060579 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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