ISRCTN53183087已完成未知
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 个研究点目标入组 124 人开始时间: 2008年7月3日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 124
研究概览
简要总结
2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21816079 [added 28/02/2019]
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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)
排除标准
- •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)
研究者
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