Guangzhou Surveillance and Clinical Study in Microcephaly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47,369
- 试验地点
- 1
- 主要终点
- Prevalence of microcephaly
研究概览
简要总结
Screening for microcephaly is important at birth and during early childhood. The Guangzhou Surveillance and Clinical Study in Microcephaly (GSCSM) aims to establish a multicentric surveillance system for microcephaly in newborns and infants, to develop a new head circumference reference and microcephaly criteria basing on the local population in Guangzhou, to improve the prediction model of microcephaly, and to follow up the outcomes of the children diagnosed with microcephaly.
详细描述
Microcephaly is associated with neurological dysfunctions in infants and children. There is not a uniform diagnostic criteria for microcephaly. The World Health Organization (WHO) recommended a criteria of head circumference (HC) less than 2 standard deviations (SD) below the mean of the Intergrowth-21 standard, which was found not applicable to the newborns and infants in Guangzhou.In the GSCSM, the HC measures of newborns are conducted by trained midwives using a standard tool, and extensive information including adverse perinatal outcomes are collected. Longitudinal follow up of infants' neurodevelopment in cognitive, motor, emotional and other domains are also to be conducted. The GSCSM intends to find out the infants who are 'real microcephaly' and most at risk of short-term or long-term adverse outcomes in Guangzhou.
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
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Newborns born after 24+0 weeks of gestation
- •Newborns delivered at the study hospitals
排除标准
- •With major congenital abnormalities
- •Multiple births
结局指标
主要结局
Prevalence of microcephaly
时间窗: At birth
Assessed by the head circumference measured using a standard tool
次要结局
- Neurodevelopmental performance of children(At birth, 6 weeks, 6 months, 1 year and 2 years)
- Head circumference changes of children(At birth, 6 weeks, 6 months, 1 year to 2 years)
研究者
Xiu Qiu
Director of the Born in Guangzhou Cohort Study
Guangzhou Women and Children's Medical Center