Clinical trial NCT02779907: Prevalence and Associations of Paediatric Chronic Suppurative Otitis Media and Hearing Impairment in Rural Malawi
Official title: Prevalence and Associations of Paediatric Chronic Suppurative Otitis Media and Hearing Impairment in a Rural District of Malawi: A Cross-sectional Survey
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Suppurative Otitis Media
Hearing Impairment
Keywords: Paediatric
Malawi
Lead sponsor: Liverpool School of Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Kamuzu University of Health Sciences
name: Malawi-Liverpool-Wellcome Trust Clinical Research Programme
First posted: 2016-05-23
Enrollment: 270
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 4-6 years living in the Chikwawa District

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Chronic Suppurative Otitis Media
timeFrame: Day1; This is a Cross-Sectional Survey and each participant will be assessed once. Therefore the outcome will be measured at data collection.
Secondary outcomes:
measure: Hearing Impairment at more than 25 decibels hearing loss cutoff at 1000Hz, 2000Hz and 4000Hz
timeFrame: Day 1; This is a Cross-Sectional Survey and each participant will be assessed once. Therefore the outcome will be measured at data collection.
Other outcomes:
Locations:
city: Iratu
country: Malawi
facility: Malawi-Liverpool-Wellcome Trust Clinical Research Program Chikwawa District Hospital Field Research Sute
state: Chikwawa
Study officials:
affiliation: LSTM
name: Kevin Mortimer, PHD, MBBS
role: PRINCIPAL_INVESTIGATOR
References: