A randomised trial to investigate the effect of a rehabilitation program for cognitive deficits in Ugandan children after central nervous system malaria

Swedish International Development Cooperation Agency (SIDA) (Sweden)0 sites124 target enrollmentJuly 3, 2008

Overview

Phase: 未知
Intervention: Not specified
Conditions: Malaria with CNS involvement
Sponsor: Swedish International Development Cooperation Agency (SIDA) (Sweden)
Enrollment: 124
Status: Completed
Last Updated: 7 years ago

Registry

who.int

Start Date

July 3, 2008

End Date

October 1, 2010

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

Swedish International Development Cooperation Agency (SIDA) (Sweden)

•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

•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