Rotavirus Infection
Conditions
Keywords
rotavirus,, acute gastroenteritis, vaccination, Estonia, impact, severity scales
Brief summary
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
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.
Interventions
None listed
Sponsors
University of Tartu
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* children aged \< 18 year * hospitalized due to acute gastroenteritis
Exclusion criteria
* children aged \> 18 years * gastroenteritis due to known non-infectious causes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis | up to 2 years | Evaluate the impact of rotavirus vaccination on hospitalizations due to acute gastroenteritis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The severity of disease according to Vesikari and Clark severity scales | up to 2 years | Measure the severity of disease according to Vesikari and Clark severity scales |
Other
| Measure | Time frame | Description |
|---|---|---|
| The prevalence of rotavirus, adenovirus, astrovirus, norovirus G1, G2 and sapovirus gastroenteritis in Estonia after the implementation of rotavirus vaccine | up to 2 years | Determine the prevalence of rotavirus, adenovirus, astrovirus, norovirus G1, G2 and sapovirus gastroenteritis in Estonia after the implementation of rotavirus vaccine |
| Rotavirus genotypes | up to 2 years | Determine the genotypes of circulating rotavirus |
| Intussusception | up to 2 years | Monitor the incidence of intussusception during the study period |
Countries
Estonia
Outcome results
None listed