A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Children <6 Years of Age in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13,767
- 主要终点
- Occurrence of rotavirus gastroenteritis among all acute gastroenteritis hospitalizations in children aged <6 years
研究概览
简要总结
The purpose of this study is to evaluate the epidemiology and baseline disease burden of rotavirus gastroenteritis in children < 6 years of age, in Japan.
详细描述
This is a retrospective database study wherein data on children who have been diagnosed with acute gastroenteritis or rotavirus gastroenteritis will be collected from the electronic admission database or any other applicable database of the participating hospitals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A male or female child aged <6 years at the time of admission in hospital. A child will become ineligible on the day of her/his sixth birthday.
- •A subject who is hospitalized with any acute gastroenteritis or rotavirus gastroenteritis during the survey period.
排除标准
- •Participants of any kind of rotavirus vaccine clinical trial.
结局指标
主要结局
Occurrence of rotavirus gastroenteritis among all acute gastroenteritis hospitalizations in children aged <6 years
时间窗: At least 24 months (from 01 January 2008 to 31 December 2009)
Occurrence of acute gastroenteritis among all hospitalized children aged <6 years
时间窗: At least 24 months (from 01 January 2008 to 31 December 2009)
Occurrence of rotavirus gastroenteritis among all hospitalized children aged <6 years
时间窗: At least 24 months (from 01 January 2008 to 31 December 2009)
次要结局
- Age (monthly) specific data of all the outcome measures, for children <12 months of age(At least 24 months (from 01 January 2008 to 31 December 2009))
- Number of hospitalizations with rotavirus gastroenteritis and other vaccine-preventable infectious diseases such as influenza, mumps and varicella among children <6 years of age(At least 24 months (from 01 January 2008 to 31 December 2009))
- Occurrence of nosocomial rotavirus gastroenteritis among all hospitalized children aged <6 years(At least 24 months (from 01 January 2008 to 31 December 2009))
- Occurrence of nosocomial rotavirus gastroenteritis among all hospitalizations with rotavirus gastroenteritis in children aged <6 years(At least 24 months (from 01 January 2008 to 31 December 2009))
- Occurrence of rotavirus gastroenteritis hospitalization and nosocomial rotavirus gastroenteritis hospitalization among children <6 years of age, stratified by age(At least 24 months (from 01 January 2008 to 31 December 2009))
- Prolongation of hospitalization of patients with nosocomial rotavirus gastroenteritis(At least 24 months (from 01 January 2008 to 31 December 2009))
- Seasonal distribution (monthly) of rotavirus gastroenteritis infection(At least 24 months (from 01 January 2008 to 31 December 2009))