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

Sponsor

Liverpool School of Tropical Medicine (Other)

Overall Status

Unknown status

CT.gov ID

NCT02779907

Collaborator

University of Malawi College of Medicine (Other), Malawi-Liverpool-Wellcome Trust Clinical Research Programme (Other)

270

Enrollment

Location

Duration (Months)

66.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Suppurative Otitis Media Hearing Impairment	Other: No Intervention

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

270 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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 Start Date :

May 1, 2016

Anticipated Primary Completion Date :

Jul 1, 2016

Anticipated Study Completion Date :

Sep 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Study Population Children aged 4-6 years resident in Chikwawa District.	Other: No Intervention No interventions planned for this observational study

Arm

Intervention/Treatment

Study Population

Children aged 4-6 years resident in Chikwawa District.

Other: No Intervention

No interventions planned for this observational study

Outcome Measures

Primary Outcome Measures

Chronic Suppurative Otitis Media [Day1; This is a Cross-Sectional Survey and each participant will be assessed once. Therefore the outcome will be measured at data collection.]
Chronic Suppurative Otitis Media will be defined as per the the World Health Organisation ear and hearing survey diagnostic criteria. To assign a diagnosis, tympanic membrane images and clinical data for each participant will be reviewed by two ENT surgeons who will assign a diagnosis. Disagreements will be resolved by a third 'tiebreaker'.

Secondary Outcome Measures

Hearing Impairment at more than 25 decibels hearing loss cutoff at 1000Hz, 2000Hz and 4000Hz [Day 1; This is a Cross-Sectional Survey and each participant will be assessed once. Therefore the outcome will be measured at data collection.]
Hearing impairment will be defined as per the World Health Organisation definition of mild hearing impairment (25 decibels hearing loss). Each participant's hearing will be assessed using a screening audiometer.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 6 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)