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Clinical Trial Summary

This community-based cross-sectional survey will estimate the frequency and risk factors of Chronic Suppurative Otitis Media and Hearing Impairment in Children ages 4-6 years in the Chikwawa District. These data will be useful for service planning, disease prevention efforts and to guide future research in this field.


Clinical Trial Description

Type of research study:

Cross sectional survey

Problem to be studied:

Chronic suppurative otitis media and hearing impairment are important causes of morbidity, affecting 4-10% of children throughout sub-Saharan Africa. Many of the causes of disease are preventable with simple interventions. There is significant variation in disease burden and causes between countries, and currently no data on the frequency and causes of disease in Malawi.

Previous studies suggest poverty, crowding, paternal smoking and indoor cooking all increase the risk of developing chronic suppurative otitis media. The associations with use of an efficient cookstove have not been studied. The causes of childhood hearing impairment vary significantly by region and include otitis, other infections and cryptogenic causes.

Objectives:

- Estimate the prevalence of CSOM and other ear pathology in a population representative sample of 4-6 year-old children in a rural district of Malawi.

- Describe associations (including household use of an efficient cookstove) of CSOM

- Estimate the prevalence of hearing impairment defined by screening audiometry in a population representative sample of 4-6 year-old children in a rural district of Malawi.

- Describe associations of hearing impairment in a population representative sample of 4-6 year-old children in a rural district of Malawi.

Methodology:

A village level cluster survey in the Chikwawa district of Malawi. The study will survey 270 children across 10 systematically determined clusters using 2008 census data. The investigators will undertake video otoscopy and basic hearing screening in the field using a validated smartphone screening tool. The research will also look for associations between chronic middle ear infection and potential risk factors for disease using negative binomial regression. This will include household use of an efficient cookstove.

Expected findings and their dissemination:

The investigators will establish the prevalence and associations of chronic suppurative otitis media and of hearing impairment in children aged 4-6 years in the Chikwawa district. The investigators hope these data will guide further development of ENT service in Malawi, and may indicate possible preventative strategies. The results will be disseminated to the communities, local health services and the College of Medicine of Malawi. ;


Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


NCT number NCT02779907
Study type Observational
Source Liverpool School of Tropical Medicine
Contact Luke Hunt, MBBS
Email 8944@lstmed.ac.uk
Status Recruiting
Phase N/A
Start date May 2016
Completion date September 2016

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