The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children After Introduction of Rotavirus Vaccines

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Epidemiology and Etiology of Acute Gastroenteritis Among Estonian Children Aged < 18 Years After Introduction of Rotavirus Vaccines

Conditions
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Rotavirus Infection

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children aged < 18 year hospitalized due to acute gastroenteritis Exclusion Criteria: children aged > 18 years gastroenteritis due to known non-infectious causes

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hospitalized AGE patients<br>Children less than 18-years-old hospitalized due to acute gastroenteritis to seven Estonian hospitals participating in this study | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis | Evaluate the impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity of disease according to Vesikari and Clark severity scales | Measure the severity of disease according to Vesikari and Clark severity scales | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rotavirus,, acute gastroenteritis, vaccination, Estonia, impact, severity scales