The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children Aged < 18 Years After Introduction of Rotavirus Vaccines
试验速览
- 阶段
- 不适用
- 入组人数
- 2,260
- 试验地点
- 1
- 主要终点
- The impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis
研究概览
简要总结
This study is designed to estimate the changes in the etiology and epidemiology of acute gastroenteritis in children aged less than 18 years after the implementation of rotavirus vaccine in the Estonian national immunization program in July 2014.
详细描述
The two-year study period started in February 2015.
The study population consists of all children less than 18-years-old hospitalized due to acute gastroenteritis (AGE) to seven Estonian hospitals participating in this study. Expected sample size is about 2000 patients.
Hospitals that participate in this study are Tartu University Hospital, West-Tallinn Central Hospital, Tallinn's Children Hospital, Pärnu Central Hospital, South-Estonian Hospital, Kuressaare Hospital and Ida-Viru Central Hospital.
Before enrollment all patients are asked to give an informed consent. After enrollment the study doctor completes electronic questionnaire regarding the patients demographic data, medical history and vaccinations. Specific database for our study has been created by company Vision 5D. After completing electronic questionnaire the doctor collects 2 stool samples each 2 ml of volume into Eppendorf tubes produced by our study laboratory. The samples are transported to our study laboratory where they are tested for rotavirus, norovirus G1, G2, astrovirus, adenovirus and sapovirus with Fast-Track Diagnostics real-time assay kit FTD Viral Gastroenteritis. The samples positive for rotavirus are refrigerated at -70 degrees for further genotyping and sequencing.
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 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children aged < 18 year
- •hospitalized due to acute gastroenteritis
排除标准
- •children aged > 18 years
- •gastroenteritis due to known non-infectious causes
结局指标
主要结局
The impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis
时间窗: up to 2 years
Evaluate the impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis
次要结局
- The severity of disease according to Vesikari and Clark severity scales(up to 2 years)
研究者
Kadri Kõivumägi
PhD student
University of Tartu
