Surveillance of Zika-related Microcephaly in Sub-Saharan Africa and Asia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 150
- 试验地点
- 8
- 主要终点
- Proportion of microcephaly linked to other infectious etiologies
研究概览
简要总结
This study will explore whether ZIKV is currently responsible for neurological complications, and particularly microcephaly, in Aedes-infested regions of Sub-Saharan Africa (SSA) and Asia. This will inform regional public health strategies, such as vaccination of women of child-bearing age. It will also demonstrate the public health impact of ZIKV infection and increase the understanding of other regional infectious (e.g. cytomegalovirus) causes of microcephaly.
详细描述
This study will last for 2 years, and will include only new cases of microcephaly.
Surveillance will take place in large maternities in urban areas (standard procedure)
- In each city, ~3000 live births per month will be monitored, so that on average one microcephaly will be diagnosed per month per city (i.e., 24 per city in 2 years)
- Microcephaly is defined as less than -3 standard deviation (SD), according to the INTERGROWTH standards by age and sex with abnormal ultrasound and/or clinical examination.
Data collection (study activity)
- A questionnaire with demographic, exposure and pregnancy details for all mothers Clinical exam and laboratory testing (standard procedure and study activity)
- Various biological samples (e.g. blood, placenta) will be collected from mothers and newborns/fetuses and tested for presence of ZIKV, and for other infectious (e.g. rubella, cytomegalovirus) causes of microcephaly
- Physical, neurological, hearing and visual examinations for all live births will be performed where possible.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Days 至 2 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All infants or fetuses with microcephaly, (defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex, detected during the mother's pregnancy, or at the end of the mother's pregnancy at one of the participating maternities)
- •and with abnormal ultrasound and/or clinical examination findings for newborns.
排除标准
- •Infants/fetuses with microcephaly whose mothers are under the age of 18 years,
- •or inability or refusal of mothers/ guardians to give informed consent.
结局指标
主要结局
Proportion of microcephaly linked to other infectious etiologies
时间窗: At birth
Proportion of microcephaly linked to other infectious etiologies (non-ZIKV)
Incidence of microcephaly (per 10,000 live births)
时间窗: At birth
Incidence of microcephaly (per 10,000 live births)
Proportion of microcephaly attributable to ZIKV
时间窗: At birth
Proportion of microcephaly attributable to Zika virus infection
次要结局
未报告次要终点