Prevalence and Associations of Paediatric Chronic Suppurative Otitis Media and Hearing Impairment in Rural Malawi
NCT ID: NCT02779907
Last Updated: 2016-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
270 participants
OBSERVATIONAL
2016-05-31
2016-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Study Population
Children aged 4-6 years resident in Chikwawa District.
No Intervention
No interventions planned for this observational study
Interventions
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No Intervention
No interventions planned for this observational study
Eligibility Criteria
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Inclusion Criteria
* Resident in the CAPS study area in the Chikwawa district of southern Malawi
* Parental consent and child's assent to inclusion in the study
Exclusion Criteria
* Participant refusal to assent to participation
* Participant unable to explicitly assent to involvement in the study (e.g. developmental delay, learning difficulties, unwell)
4 Years
6 Years
ALL
Yes
Sponsors
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Kamuzu University of Health Sciences
OTHER
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
OTHER
Liverpool School of Tropical Medicine
OTHER
Responsible Party
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Principal Investigators
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Kevin Mortimer, PHD, MBBS
Role: PRINCIPAL_INVESTIGATOR
LSTM
Locations
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Malawi-Liverpool-Wellcome Trust Clinical Research Program Chikwawa District Hospital Field Research Sute
Iratu, Chikwawa, Malawi
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LOI 0182
Identifier Type: -
Identifier Source: org_study_id
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