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

June 3, 2016 updated by: Liverpool School of Tropical Medicine

Prevalence and Associations of Paediatric Chronic Suppurative Otitis Media and Hearing Impairment in a Rural District of Malawi: A Cross-sectional Survey

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malawi
    • Chikwawa
      • Iratu, Chikwawa, Malawi, PB. 01234
        • Recruiting
        • Malawi-Liverpool-Wellcome Trust Clinical Research Program Chikwawa District Hospital Field Research Sute
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children aged 4-6 years living in the Chikwawa District

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic Suppurative Otitis Media
Time Frame: 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'.
Day1; This is a Cross-Sectional Survey and each participant will be assessed once. Therefore the outcome will be measured at data collection.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing Impairment at more than 25 decibels hearing loss cutoff at 1000Hz, 2000Hz and 4000Hz
Time Frame: 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.
Day 1; This is a Cross-Sectional Survey and each participant will be assessed once. Therefore the outcome will be measured at data collection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liverpool School of Tropical Medicine

Collaborators

Kamuzu University of Health Sciences
Malawi-Liverpool-Wellcome Trust Clinical Research Programme

Investigators

  • Principal Investigator: Kevin Mortimer, PHD, MBBS, LSTM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

September 1, 2016

Study Registration Dates

First Submitted

May 6, 2016

First Submitted That Met QC Criteria

May 19, 2016

First Posted (Estimate)

May 23, 2016

Study Record Updates

Last Update Posted (Estimate)

June 6, 2016

Last Update Submitted That Met QC Criteria

June 3, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LOI 0182

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participants will be consented for anonymised data storage for further research up to a period of 5 years following completion of the study. These data will be held on a secure server at LSTM by the principal investigator. Data may be shared with any interested parties following successful ethical review from COMREC and LSTM.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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