A Cross Sectional Evaluation of the Development in Children Age 4 to 7 Infected or Exposed to HIV From the ANRS 12140 Cohort (Pediacam)
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Global motor development (Touwen test), global cognitive development (K-ABC II test), visual (Log Mar Char) and hearing (full ear nose and throat examination) impediments
研究概览
简要总结
This study aims to perform a comprehensive neuro-cognitive evaluation of the 4-7 year old children from the Pediacam cohort (ANRS 12140 /12225, NCT02043418). It is expected thereby to provide complementary information to the trials CHER and PREDICT on the long term development of (1) HIV-infected children according to age at ARV initiation and (2) HIV exposed but not infected children, all compared with the control group of children uninfected, unexposed to HIV.
详细描述
Cognitive, motor and sensorial impairments associated to HIV infection have been and remain important concerns in children. The advent of ARV has reduced the frequency and the extent of HIV-related encephalopathys, but literature suggests that more limited impairments remain (CHER and PREDICT trials). These neuro-cognitive disorders might constitute an important public health problem in sub-Saharan Africa where a high percentage of children born to HIV+ women live. Nevertheless,the knowledge on their long-term consequences on children development in this context remains limited. Data on the burden of cognitive, motor and sensorial impairment in resource-limited settings as well as on the interaction with other factors that could also impair children development are scarse.
The Pediacam cohort gives the opportunity to better understand the development of children born to HIV-infected mothers - infected by HIV or not - followed up from birth and living in sub-Saharan Africa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 4 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children included in the Pediacam cohort and age 4 to 7
- •Parent or guardian written informed consent obtained
排除标准
- 未提供
研究组 & 干预措施
HIV-infected children diagnosed before 7 months of life
HIV-infected children diagnosed before 7 months of life
干预措施: HIV-infected children initiated antiretroviral treatment within the first 7 months of life (Other)
HIV-exposed uninfected children
HIV-uninfected children born to HIV-infected mothers
干预措施: HIV-infected children initiated antiretroviral treatment within the first 7 months of life (Other)
HIV-unexposed uninfected children
Children born to HIV-uninfected mothers
干预措施: HIV-infected children initiated antiretroviral treatment within the first 7 months of life (Other)
结局指标
主要结局
Global motor development (Touwen test), global cognitive development (K-ABC II test), visual (Log Mar Char) and hearing (full ear nose and throat examination) impediments
时间窗: 4-7 years of age
Frequency of cognitive, motor and sensorial impairments in 4-7 year old children born to HIV+ mothers who received early treatment in the first 7 months of life
次要结局
- Effect of early ARV (<3 months) versus differed ARV (between 3 and 7 months) on neurocognitive impairments(4-7 years of age)
- Prognostic factors and consequences of HIV-associated neuro-cognitive impairments(4-7 years of age)
- Compared frequency of motor, cognitive and sensorial impairments between infected and uninfected children(4-7 years of age)