The Prevalence of Rheumatic Heart Disease in School Children in Fiji

Rheumatic Heart Disease Clinical Trial

Official title:

The Prevalence of Rheumatic Heart Disease in School Children in Fiji

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00779662
• Other study ID #: 07- 0070
• Secondary ID: U01AI060579
• Status: Active, not recruiting
• Phase: N/A
• First received: October 23, 2008
• Last updated: October 23, 2008
• Start date: February 2008
• Est. completion date: December 2008

Study information

• Verified date: October 2008
• Source: Queensland Institute of Medical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 14 Years

Eligibility

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:

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Heart Diseases
• Rheumatic Diseases
• Rheumatic Heart Disease

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Queensland Institute of Medical Research	Menzies School of Health Research, National Institute of Allergy and Infectious Diseases (NIAID), University of Melbourne