Establishment and Application of the National Surveillance Network for Enterovirus During the Perinatal Period
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 6,500
- 试验地点
- 1
- 主要终点
- Detection of enterovirus
研究概览
简要总结
Neonates could be infected by non-polio enterovirus easily. Some of the neonates may develop fatal complications within one week. The objective of this study were as following: 1.To understand the composition and epidemiological characteristics of enterovirus infection in pregnant women in some areas of China; 2.To understand the transmission from mother to their neonates; 3.To understand the pathogenic spectrum composition, epidemiological characteristics and clinical characteristics of enterovirus infection in neonates; 4.To understand the genetic variation and changes of enteroviruses; 5.To establish a quality management system for maternal and neonatal enterovirus laboratory testing and monitoring.
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 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •General parturient: on the first day of the third week of each month, all parturients and their newborns admitted to the hospital (day shift 8:00-18:00) within that day;
- •Puerpera with fever: all puerperas with fever (body temperature >=37.5 degree C) and their newborns were included in summer and autumn (from May);
- •Febrile newborns: those included in summer and autumn (from May) with the following clinical characteristics: fever >=37.5 degree C, lasting for more than one day. And sign the informed consent form with the consent of the guardian.
排除标准
- •Pregnant women with urinary tract infection, chorioamnionitis and bacterial infection;
- •Puerpera with fever due to urinary tract infection, chorioamnionitis and bacterial infection;
- •Newborns infected with other pathogens.
结局指标
主要结局
Detection of enterovirus
时间窗: 42 days
Detection of the rate of enterovirus infection and identify the genotype of enterovirus.
次要结局
- Detection of antibodies of enterovirus(42 days)