Prevalence and Associations of Paediatric Chronic Suppurative Otitis Media and Hearing Impairment in Rural Malawi
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|ClinicalTrials.gov Identifier: NCT02779907|
Recruitment Status : Unknown
Verified June 2016 by Liverpool School of Tropical Medicine.
Recruitment status was: Recruiting
First Posted : May 23, 2016
Last Update Posted : June 6, 2016
|Condition or disease||Intervention/treatment|
|Chronic Suppurative Otitis Media Hearing Impairment||Other: No Intervention|
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.
- 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.
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|
|Estimated Enrollment :||270 participants|
|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 2016|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||September 2016|
Children aged 4-6 years resident in Chikwawa District.
Other: No Intervention
No interventions planned for this observational study
- 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'.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02779907
|Contact: Luke Hunt, MBBSemail@example.com|
|Contact: Carl Henry, PHD||00 44 151 705 firstname.lastname@example.org|
|Malawi-Liverpool-Wellcome Trust Clinical Research Program Chikwawa District Hospital Field Research Sute||Recruiting|
|Iratu, Chikwawa, Malawi, PB. 01234|
|Contact: Luke Hunt, MBCHB +265997095519 email@example.com|
|Contact: Victoria Knott, MBCHB +265997095519 firstname.lastname@example.org|
|Principal Investigator:||Kevin Mortimer, PHD, MBBS||LSTM|