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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
Sponsor:
Collaborators:
University of Malawi College of Medicine
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Information provided by (Responsible Party):
Liverpool School of Tropical Medicine

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
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.


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Study Type : Observational
Estimated 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 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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'.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Children aged 4-6 years living in the Chikwawa District
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)

Information from the National Library of Medicine

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


Contacts
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Contact: Luke Hunt, MBBS 8944@lstmed.ac.uk
Contact: Carl Henry, PHD 00 44 151 705 3794 carl.henry@lstmed.ac.uk

Locations
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Malawi
Malawi-Liverpool-Wellcome Trust Clinical Research Program Chikwawa District Hospital Field Research Sute Recruiting
Iratu, Chikwawa, Malawi, PB. 01234
Contact: Luke Hunt, MBCHB    +265997095519    8944@lstmed.ac.uk   
Contact: Victoria Knott, MBCHB    +265997095519    v-knott@doctors.org.uk   
Sponsors and Collaborators
Liverpool School of Tropical Medicine
University of Malawi College of Medicine
Malawi-Liverpool-Wellcome Trust Clinical Research Programme
Investigators
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Principal Investigator: Kevin Mortimer, PHD, MBBS LSTM

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Responsible Party: Liverpool School of Tropical Medicine
ClinicalTrials.gov Identifier: NCT02779907     History of Changes
Other Study ID Numbers: LOI 0182
First Posted: May 23, 2016    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Keywords provided by Liverpool School of Tropical Medicine:
Paediatric
Malawi

Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Otitis
Otitis Media
Suppuration
Infection
Otitis Media, Suppurative
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Inflammation
Pathologic Processes