NCT00751686已完成不适用
To Estimate the Burden of Rotavirus Gastroenteritis (RV GE) in Children < 5 Years of Age in Greece
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Estimation of the proportion of RV GE among all acute GE emergency room visits among children <5 years of age.
研究概览
简要总结
The purpose of this study is to measure the disease burden from RV GE among children less than 5 years of age using hospital surveillance data. In addition, data collected will determine the seasonal distribution, disease severity, age distribution of RV GE. From an economic standpoint, the cost and impact of RV will also be assessed.
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 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A male or female child < 5 years of age at the time of the visit (a child becomes ineligible on the day of her/his 5th birthday).
- •Child is brought to the emergency room for acute GE during the study period or develop acute GE at least 48 hours after hospitalisation.
- •Written informed consent obtained from the parent/guardian of the subject.
- •Children with RV positive stool sample will be enrolled in the study.
排除标准
- •Not applicable.
结局指标
主要结局
Estimation of the proportion of RV GE among all acute GE emergency room visits among children <5 years of age.
时间窗: Approximately 12 months
Estimation of the proportion of RV GE among all acute GE hospitalisations among children <5 years of age.
时间窗: Approximately 12 months
Estimation of the incidence of nosocomial RV GE among all hospitalised children <5 years of age.
时间窗: Approximately 12 months
次要结局
- Determination of the age of the children, disease severity, and the seasonal distribution of RV GE among children <5 years of age.(Approximately 12 months)
- Identification of prevalent genotypes of RV among children <5 years of age.(Approximately 12 months)
- Assessing the costs related to the episodes of RV GE, by the completion of the Health Economic Questionnaire (interview with the parent for a subset of subjects) and the cost checklist provided by the hospital's site staff.(Approximately 12 months)
研究者
研究点 (1)
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