Condition category
Infections and Infestations
Date applied
21/03/2013
Date assigned
28/05/2013
Last edited
28/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Prof Abul Faiz

ORCID ID

Contact details

Mahidol Oxford Research Unit
Faculty of Tropical Medicine
Mahidol University
420/6 Rajvithi Rd
Bangkok
10400
Thailand

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 measures

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

31/08/2014

Reason abandoned

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

http://www.tropmedres.ac/

Funders

Funder type

Government

Funder name

Canadian Grand Challenges (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes