Neuropsychological Development and Executive Functioning of Children Born to HIV- Infected Mothers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- evaluate the executive function of children HEU
研究概览
简要总结
Main objective: to evaluate the executive functioning of the HIV exposed uninfected children (HEU) versus children from the same socio-economic and cultural environment, not infected or affected by HIV.
Secondary objective (s): to evaluate Intellectual Quotient, Child development, Behavior, Language and investigate link between executive functioning disorders, exposure to ARVs, HIV and family environment.
详细描述
The objective of the study is the exploration of executive functions (EF) and screening for neurodevelopment and learning disorders in children born to HIV-infected mothers, exposed to the virus and to antiretrovirals (ARVs).
The evaluation of the executive functioning will be done by the score obtained at the preschool BRIEF for patients and control group issued from questionnaires filled by the mothers of the cases and the mothers of the controls, with matching on age, sex, level of parental education and socio-economic and cultural environment.
Within the group of exposed children, factors associated with executive dysfunction including HIV infection, antiretroviral exposure, maternal socio-demographic data, sociocultural and environmental level will be investigated.
Evolution of the scores between J0, M12 and M24 will be compared within the group of exposed children.
Compared with a control group, the child's intelligence quotient, overall development, behavior and language will be compared at each follow-up time (D0, M12 and M24).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •experimental:
- •HIV-positive children born to mothers living with HIV antiretrovirals during pregnancy and in the neonatal period, aged 3 years +/- 3 months on the date of inclusion.
- •Parents mastering the French.
- •children, aged 3 years +/- 3 months on the date of inclusion, from the same socio-economic and cultural environment, no infected or affected by HIV.
- •Parents mastering French.
排除标准
- •great prematurity (28-32 weeks)
- •genetic anomaly
结局指标
主要结局
evaluate the executive function of children HEU
时间窗: inclusion
Behaviour rating inventary of executive function (BRIEF) preschool version score
次要结局
- behaviour(at INCLUSION, 12 months after inclusion, 24 months after inclusion)
- functional development(at INCLUSION, 12 months after inclusion, 24 months after inclusion)
- Intellectual quotient(at INCLUSION, 12 months after inclusion, 24 months after inclusion)
- language(12 months after inclusion,)