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Prevalence and Associations of Paediatric Chronic Suppurative Otitis Media and Hearing Impairment in Rural Malawi

L

Liverpool School of Tropical Medicine

Status

Unknown

Conditions

Chronic Suppurative Otitis Media
Hearing Impairment

Treatments

Other: No Intervention

Study type

Observational

Funder types

Other

Identifiers

NCT02779907
LOI 0182

Details and patient eligibility

About

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.

Full 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.

Enrollment

270 estimated patients

Sex

All

Ages

4 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Child aged 4-6 years old
  • 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

  • Parent/guardian of participant unable to provide informed consent to their child's participation
  • Participant refusal to assent to participation
  • Participant unable to explicitly assent to involvement in the study (e.g. developmental delay, learning difficulties, unwell)

Trial design

270 participants in 1 patient group

Study Population
Description:
Children aged 4-6 years resident in Chikwawa District.
Treatment:
Other: No Intervention

Trial contacts and locations

1

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Central trial contact

Luke Hunt, MBBS; Carl Henry, PHD

Data sourced from clinicaltrials.gov

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