A Multicenter prospective hospital-based surveillance to estimate the burden of rotavirus gastroenteritis in children less than five years of age in India.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 12
- 主要终点
- Hospitalization due to Rota virus diarrhea
研究概览
简要总结
Study involves hospital-based surveillance of rotavirus gastroenteritis in children ≤ 59 months of age. A stool sample from eligible child with acute gastroenteritis who is admitted to a participating hospital will be tested for the presence of rotavirus. The study would be conducted in a well-defined population to allow calculation of the incidence of hospitalization, the principal measure of disease burden. In order to determine the genotypes present from among the rotavirus-positive stool samples, the samples would be transported to a central laboratory at Department of Gastrointestinal Sciences, Christian Medical College, Vellore. The reported cases of rotavirus diarrhea would be characterized by place or time for children living in the referral population
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Month(s) 至 59.00 Month(s)（—）
- 性别
- All
入选标准
- •â€¢All children less than and equal to 59 months of age presenting with acute gastroenteritis and requiring hospitalization with rehydration for atleast six hours.
- •â€¢parents/guardians willing to give informed consent.
排除标准
- 未提供
结局指标
主要结局
Hospitalization due to Rota virus diarrhea
时间窗: Hospitalization,at least for 6 hrs.
次要结局
- Severity of diarrheal episodes(NA)