The Neurodevelopment in Normal Children in Cambodia and Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- neurodevelopment changes (composite of cognitive, fine motor and behavioral)
研究概览
简要总结
To determine the neurodevelopment (ND) in normal children in Thailand and Cambodia and to use this group to compare the neurodevelopmental changes over time to the HIV-infected children with and without HAART (main study).
详细描述
Normative data are mostly, if not exclusively, obtained from children in the Western world. Comparing data from Asian children to these norms may lead to the wrong interpretation of the results, as it does not account for cultural differences, translation issues and a possibly different education system. Therefore it is essential to include a matched control group to evaluate the participants of the study to the fullest extent in terms of cognition, memory, behavior and fine motor skills, in all age groups over the full course of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for HIV negative exposed children
- •Child from a HIV-positive mother
- •Documented negative test for HIV-1 infection
- •Between the age from 1-15 years
- •Caregiver of the subject is willing and able to sign informed consent, prior to the study
- •Thai or Cambodian origin
- •HIV negative and not HIV exposed:
- •Child from a HIV-negative mother (by history)
- •Documented negative test for HIV-1 infection
- •Between the age from 1-15 years
- •Caregiver of the subject is willing and able to sign informed consent, prior to the study
- •Thai or Cambodian origin
排除标准
- •for HIV negative exposed children
- •The inability of the caregivers to understand the nature and extend of the trial and the procedure required
- •Patients with psychiatric disorder
- •Patients with a syndrome that affects cognitive performance
- •for HIV negative and not HIV exposed
- •The inability of the caregivers to understand the nature and extent of the trial and the procedure required
- •Patients with psychiatric disorder
- •Patients with a syndrome that affects cognitive performance
结局指标
主要结局
neurodevelopment changes (composite of cognitive, fine motor and behavioral)
时间窗: up to 96 weeks
measured by cognitive test, fine motor test and behavioral assessment test
次要结局
未报告次要终点