Prevalence and Associations of Paediatric Chronic Suppurative Otitis Media and Hearing Impairment in Rural Malawi
1 other identifier
observational
270
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 6, 2016
CompletedFirst Posted
Study publicly available on registry
May 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedJune 6, 2016
June 1, 2016
2 months
May 6, 2016
June 3, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chronic Suppurative Otitis Media
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 Outcomes (1)
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.
Study Arms (1)
Study Population
Children aged 4-6 years resident in Chikwawa District.
Interventions
Eligibility Criteria
Children aged 4-6 years living in the Chikwawa District
You may qualify if:
- Child aged 4-6 years old
- Resident in the CAPS study area in the Chikwawa district of southern Malawi
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Malawi-Liverpool-Wellcome Trust Clinical Research Program Chikwawa District Hospital Field Research Sute
Iratu, Chikwawa, PB. 01234, Malawi
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kevin Mortimer, PHD, MBBS
LSTM
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2016
First Posted
May 23, 2016
Study Start
May 1, 2016
Primary Completion
July 1, 2016
Study Completion
September 1, 2016
Last Updated
June 6, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will share
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.