Plain English Summary
Background and study aims
Malaria kills, but because it affects the central nervous system (CNS) it also causes disability. Reliable data on malaria-caused disability risk does not exist and could help prevent the burden in the future. Our research will trace children who were part of a severe malaria study between 2000-2006 in three countries in Africa and Asia (Study 13) carried out by Chittagong Medical College-Bangladesh, National Institute of Medical Research-Tanzania and Navrongo Health Research Centre- Ghana.
Who can participate?
The parents and the original cohort of children (part of study 13), who are now at an age (8-16) at which they can be assessed for functional disability will be invited to participate in the study. It will be explained that if they participate they will undergo clinical and brain function (neurocognitive) tests. The original investigators from Study 13 will be involved, supported by psychologists, trained assessors and paediatric neurologists.
What does the study involve?
The research will follow up the original cohort of children and assess them through clinical and neurocognitive tests to establish how many of the original cohort of children is normal for their age and how many have mild, moderate or gross functional impairment. It will try to determine whether the degree of functional disability is related to their history of severe or cerebral malaria and whether effective treatment given early during the episode protected the child from disability. No intervention / treatment is given in this study.
What are the possible benefits and risks of participating?
Some children may benefit from a clinical examination, and those with disabilities will be referred for care. There are no direct risks in participating.
Where is the study run from?
Bangladesh, Ghana, Tanzania
When is the study starting and how long is it expected to run for?
The study will run for approximately 24 months. First there will be preparatory development of the assessment tests and training of assessors. This should be completed by spring-2013 in Bangladesh, and pilot tested in a non-study cohort of children. Thereafter the training of assessors and pilot tests will occur in Tanzania and Ghana. Assessments of children from the study cohort will likely begin after mid-2013 and will take at least one year.
Who is funding the study?
The study funded by Grand Challenges Canada.
Who is the main contact?
Prof Abul Faiz
Mahidol Oxford Research Unit
Faculty of Tropical Medicine
Mahidol University
420/6 Rajvithi Rd
Bangkok
10400
Thailand
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Study13 Follow up
Study information
Scientific title
Long-term neurocognitive assessment of children following an episode of severe malaria: the artesunate suppository trial cohort
Acronym
SBASSMC
Study hypothesis
To describe the long-term effects of cerebral malaria or other central nervous system (CNS) infection in childhood on the prevalence of neurological deficit in a cohort re-visited 7-13 years later.
Children with history and no history of CNS malaria will be assessed clinically, psychologically and with neuro-physiological assessments.
Ethics approval
1. Ghana Navrongo Health Research Centre - Ethics approval was on 30 January 2013 ref NHRCIRB148
2. Tanzania National Institute of Medical Research Ethics approval was on 4th December 2012
3. Bangladesh Chittagong Medical College approval was on 13.10.2012
4. Oxford-OXTREC approval was on 22 October 2012: Reference 169-12
Study design
Cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Not specified
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Cerebral malaria or other CNS infection
Intervention
This is a follow up study to assess the effects of malaria on brain function. No intervention is anticipated.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
To describe the long-term effects of cerebral malaria or other CNS infection in childhood on the prevalence of neurological deficit in a cohort re-visited 7-13 years later
Secondary outcome measures
Prevalence of neurocognitive disability
1. To compare prevalence of neurological and cognitive deficits by detailed neurocognitive exams, by status at recruitment (2000-06)
2. To compare prevalence of neurological and cognitive deficits by detailed neurocognitive exams, by treatment allocation at recruitment and, where possible, by time to reach a health facility (2000-06)
3. To compare prevalence of neurological and cognitive deficits by detailed neurocognitive exam, by status at follow-up (2013-14)
4. To quantify types of disability by each separate neurocognitive test
Characterising neurological disability
1. To confirm and characterise the type of neurological damage by electro-encephalogram (EEG)
2. To confirm and characterise neurological damage by magnetic resonance imaging (MRI)
Development of screening tools
1. Develop and validate core metrics and neuro-development and cognitive instruments to measure neurocognitive disability in participating sites
2. Map using GPS all study participants houses
Overall trial start date
15/04/2013
Overall trial end date
01/03/2017
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
TQQ+ questionnaire, socioeconomic status, clinical history, height on:
1. Surviving children originally enrolled in Study 13
2. Male or female
3. Written informed consent by legally acceptable representative (plus assent if appropriate)
4. Willingness and ability of the participants/guardians to comply with the study tests
Detailed neurocognitive exams
1. ~30% stratified sample of the surviving study cohort meeting criteria above
2. TQQ positive children
3. >8 years of age
(Additional inclusion criteria will apply for participants who undergo EEG and/or MRI)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
Surviving children. ~6000
Participant exclusion criteria
TQQ+
1. Signs of acute illness
Detailed neurocognitive exams
1. Signs of acute illness
2. Anti-malarial injection at enrolment into Study 13
(Additional exclusion criteria will apply for participants who will undergo EEG and/or MRI)
Recruitment start date
15/04/2013
Recruitment end date
31/08/2014
Locations
Countries of recruitment
Bangladesh, Ghana, Tanzania
Trial participating centre
Mahidol Oxford Research Unit
Bangkok
10400
Thailand
Sponsor information
Organisation
Mahidol Oxford Tropical Medicine Research Unit (MORU) (Thailand)
Sponsor details
Mahidol University Research Unit
Faculty of Tropical Medicine
Mahidol University
420/6 Rajvithi Rd
Bangkok
10400
Thailand
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Grand Challenges Canada
Alternative name(s)
Grands Défis Canada
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Canada
Results and Publications
Publication and dissemination plan
Not provided at time of registration
IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available as informed consent for the purpose was not sought. Participants were explicitly informed that their individual data would only be made available to investigators who were part of the study. Should a later follow-up occur, and informed consent be obtained, this situation may change.
Intention to publish date
30/06/2019
Participant level data
Not expected to be available
Basic results (scientific)
Publication list