Chronic Suppurative Otitis MediaNCT02779907
Prevalence and Associations of Paediatric Chronic Suppurative Otitis Media and Hearing Impairment in Rural Malawi
An observational study of Chronic Suppurative Otitis Media and Hearing Impairment, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Suppurative Otitis Media, Hearing Impairment
- How many people
- 270 participants
- Where
- 1 siteMalawi
- Study dates
- May 2016to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 4-6 years living in the Chikwawa District
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Luke Hunt, MBBS contact
Malawi1 site, 1 recruiting
- Recruiting
Malawi-Liverpool-Wellcome Trust Clinical Research Program Chikwawa District Hospital Field Research Sute
Iratu, Chikwawa, PB. 01234
Luke Hunt, MBCHB, +265997095519, 8944@lstmed.ac.uk
Victoria Knott, MBCHB, +265997095519, v-knott@doctors.org.uk
About this study
Official title: 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.
Read the 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.
- Being tested
- No Intervention
- Keywords
- Paediatric, Malawi
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No interventions planned for this observational study
| Study group | Role | What they receive |
|---|---|---|
| Study Population | Children aged 4-6 years resident in Chikwawa District. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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
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.
Measured: Day 1; This is a Cross-Sectional Survey and each participant will be assessed once. Therefore the outcome will be measured at data collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Suppurative Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool School of Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, Malawi-Liverpool-Wellcome Trust Clinical Research Programme
- Responsible party
- Sponsor
- Investigators
- Kevin Mortimer, PHD, MBBS, Principal investigator, LSTM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02779907
- Sponsor's protocol ID
- LOI 0182
- Status last verified
- Jun 2016
- First submitted
- 6 May 2016
- Last updated
- 6 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Associations of Paediatric Chronic Suppurative Otitis Media and Hearing Impairment in a Rural District of Malawi: A Cross-sectional Survey
- ClinicalTrials.gov ID
- NCT02779907
- Acronym / sponsor ID
- LOI 0182
- Keywords
- Paediatric, Malawi
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Liverpool School of Tropical MedicineUniversity, hospital or other
- Collaborators
- Kamuzu University of Health Sciences, Malawi-Liverpool-Wellcome Trust Clinical Research Programme
- Study start
- May 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 23 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Population | – | Other: No InterventionChildren aged 4-6 years resident in Chikwawa District. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 4-6 years living in the Chikwawa District
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No InterventionNo interventions planned for this observational study | Other | Study Population |
Primary outcome
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'.
1 secondary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luke Hunt, MBBS contact
Kevin Mortimer, PHD, MBBS principal investigator
LSTM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Suppurative Otitis Media and Hearing Impairment, run by Liverpool School of Tropical Medicine at 1 site in Malawi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malawi. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luke Hunt, MBBS (8944@lstmed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2016.