Rehabilitation for cognitive deficits after central nervous system malaria in Ugandan childre

Not Applicable

Completed

• Conditions: Malaria with CNS involvement; Infections and Infestations; Plasmodium falciparum malaria

• Registration Number: ISRCTN53183087
• Lead Sponsor: Swedish International Development Cooperation Agency (SIDA) (Sweden)

Brief Summary

2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21816079 [added 28/02/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-07-03
• Study Completion: 2010-10-01
• Last Update Posted: 25 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Current information as of 05/02/2009:
Study will recruit children with central nervous system malaria (CNS) and healthy controls (HC).

Inclusion criteria for CNS group:
1. Aged five to 15 years, either sex
2. Presenting with asexual forms of P. falciparum malaria on a peripheral blood smear
3. Unarousable coma (not able to localise a painful stimulus) and no other cause for coma (normal cerebrospinal fluid [CSF])
4. A history of seizures for the present illness
5. Impaired consciousness

Inclusion criteria for HC group:
1. Aged five to 15 years, either sex
2. No other illness at present
3. Within two years of the CNS child (for CNS children aged 5 and 6 years, the HC's age won't go below 5 and for CNS children aged 14 and 15, the HC's age won't go above 15 years)

Initial information at the time of registration:
Study will recruit children with cerebral malaria (CM) and healthy controls (HC).

Inclusion criteria for CM group:
1. Aged five to 15 years, either sex
2. Presenting with asexual forms of P. falciparum malaria on a peripheral blood smear
3. Unarousable coma (not able to localise a painful stimulus) and no other cause for coma (normal cerebrospinal fluid [CSF])

Inclusion criteria for HC group:
1. Aged five to 15 years, either sex
2. No other illness at present
3. Within two years of the CM child (for CM children aged 5 and 6 years, the HC?s age won't go below 5 and for CM children aged 14 and 15, the HC?s age won't go above 15 years)

Exclusion Criteria

Amended as of 20/10/2010:
Please note that the exclusion of HIV children has been removed as of 20/10/2010, meaning that children infected with HIV will now be allowed to participate in this trial.

Initial information at time of registration:
Exclusion criteria for CNS* group:
1. History of or present meningitis, encephalitis, prior CNS*, sickle cell disease (SCD), human immunodeficiency virus (HIV) infection, epilepsy, multiple seizures
2. Developmental delay
3. History of hospitalisation for malnutrition

Exclusion criteria for HC group:
1. History of or present bacterial meningitis, encephalitis, CNS, SCD, HIV infection
2. History of hospitalisation for malnutrition
3. Any chronic illness for which the patient is currently taking medication

* Please note that this changed from CM to CNS on 05/02/09 in response to updates from the Principal Investigator)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Attention measured by the Test of Variables of Attention (TOVA).<br><br> Primary and secondary outcomes will be measured at 3 months post-discharge (just before intervention starts) and at 6 months post-discharge (a month after intervention).<br>