A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Japan

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Retrospective Survey of the Burden of Rotavirus Gastroenteritis (RV GE) and Nosocomial RV GE in Children <6 Years of Age in Japan

Conditions
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Nosocomial Rotavirus Gastroenteritis, Rotavirus Gastroenteritis

Intervention / Treatment
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* Other: Database analysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Participants of any kind of rotavirus vaccine clinical trial.

Ages Eligible for Study
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Maximum Age: 6 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 |
| --- | --- |
| Study Cohort<br>Subjects hospitalized with acute gastroenteritis or rotavirus gastroenteritis | Other: Database analysis<br>* Review and collect data from database (electronic admission database or any other applicable database of the hospital)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of acute gastroenteritis among all hospitalized children aged <6 years |  | At least 24 months (from 01 January 2008 to 31 December 2009) | 
| Occurrence of rotavirus gastroenteritis among all hospitalized children aged <6 years |  | At least 24 months (from 01 January 2008 to 31 December 2009) | 
| Occurrence of rotavirus gastroenteritis among all acute gastroenteritis hospitalizations in children aged <6 years |  | At least 24 months (from 01 January 2008 to 31 December 2009) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| Prolongation of hospitalization of patients with nosocomial rotavirus gastroenteritis |  | 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) | 
| Seasonal distribution (monthly) of rotavirus gastroenteritis infection |  | At least 24 months (from 01 January 2008 to 31 December 2009) | 
| 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) |