NCT00779662

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2008

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 24, 2008

Status Verified

October 1, 2008

Enrollment Period

10 months

First QC Date

October 23, 2008

Last Update Submit

October 23, 2008

Conditions

Keywords

Rheumatic Heart DiseaseStreptococcusFiji

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • Informed consent will be obtained for all participants
  • All children between the ages of 5-14 Years are eligible for the study.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rheumatic Heart Disease

Condition Hierarchy (Ancestors)

Rheumatic FeverStreptococcal InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsHeart DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 23, 2008

First Posted

October 24, 2008

Study Start

February 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

October 24, 2008

Record last verified: 2008-10