A Cross-sectional Study of Congenital Cytomegalovirus Infection in Newborns in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,510
- 试验地点
- 4
- 主要终点
- Number of cCMV infection in newborns
研究概览
简要总结
The primary objectives of this study were to evaluate the incidence of congenital CMV infection in neonates, and assess the concordance of detecting congenital cytomegalovirus (CMV) infection in neonatal saliva and urine samples.
详细描述
This Cross-sectional study was conducted to recruit neonates less than 14 days old delivered in Maternal and Child Health Hospitals (MCHHs) of Xinmi City, Jiaxian County, Zhongmu County and Huli District Xiamen City, in China, from June 2015 to June 2016. The aim of this study is to enroll ~1800 neonates, and collect their saliva and urine samples which will be tested the CMV DNA by using real-time PCR.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 14 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neonates aged 0 to 14 days
- •Neonates delivered in MCHHs of Xinmi City, Jiaxian County, Zhongmu County and Huli District Xiamen City
排除标准
- •the parents of neonates not comply with our study
结局指标
主要结局
Number of cCMV infection in newborns
时间窗: up to 5 months
次要结局
- the Kappa value of CMV prevalence between saliva and urine samples(up to 5 months)
研究者
Jun Zhang
Vice dean of School of Public Health,Xiamen University
Xiamen University