A prospective (partially retrospective) observational study to assess the burden of severe rotavirus gastroenteritis (RVGE) in four pediatric clinics and one hospital in Shibata-City, Niigata Prefecture, Japan.

A prospective (partially retrospective) observational study to assess the burden of severe rotavirus gastroenteritis (RVGE) in four pediatric clinics and one hospital in Shibata-City, Niigata Prefecture, Japan. - Shibata RVGE Study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016520

Enrollment

Registered

2015-02-12

Start date

2013-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe rotavirus gastroenteritis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria for the prospective data collection 1) Patients who visit a study site due to AGE, who live in the study area Inclusion criteria for the retrospective data collection 1) Children aged less than five years hospitalized for RV GE (ICD code: A08.0) , AGE (ICD codes: AA00-AA09) or any cause from 2011 to 2022, who live in the study area

Exclusion criteria

Exclusion criteria: Exclusion criteria 1)Patients with any disease in which abnormal immune function is present 2)Patients receiving immunosuppressive treatment 3)Patients with congenital gastrointestinal disorders

Design outcomes

Primary

Measure	Time frame
-Occurrence of severe RVGE outpatients among severe AGE outpatients / all AGE outpatients in children less than 5 years of age -Occurrence of RVGE hospitalization among hospitalized AGE / all hospitalized children less than 5 years of age	—

Secondary

Measure	Time frame
-Occurrence of severe RV GE / hospitalized RV GE cases by calendar months and year in children less than 5 years of age -Occurrence of severe AGE / hospitalized AGE cases by calendar months and year, and patients' age in children less than 5 years of age -Occurrence of all AGE / all hospitalized cases by calendar months and year, and patients' age in children less than 5 years of age -Number of patients with severe RVGE / severe AGE / all AGE less than 5 years of age -Number of hospitalized patients with severe RVGE / severe AGE / all causes less than 5 years of age -Proportion of dehydration / convulsion / high body temperature and color of diarrheal stools / number of times of diarrhea/vomiting within 24 hours among severe RVGE / hospitalized RVGE in children less than 5 years of age -Distribution of body temperature among severe RVGE / hospitalized RVGE in children less than 5 years of age -Distribution of the genotypes of RV among hospitalized and severe RVGE in children less than 5 years of age -Incidence of severe and hospitalized RVGE of data collection period -Incidence of severe and hospitalized AGE of data collection period -Incidence of all AGE and all hospitalization of data collection period	—

Measure

Time frame

-Occurrence of severe RV GE / hospitalized RV GE cases by calendar months and year in children less than 5 years of age -Occurrence of severe AGE / hospitalized AGE cases by calendar months and year, and patients' age in children less than 5 years of age -Occurrence of all AGE / all hospitalized cases by calendar months and year, and patients' age in children less than 5 years of age -Number of patients with severe RVGE / severe AGE / all AGE less than 5 years of age -Number of hospitalized patients with severe RVGE / severe AGE / all causes less than 5 years of age -Proportion of dehydration / convulsion / high body temperature and color of diarrheal stools / number of times of diarrhea/vomiting within 24 hours among severe RVGE / hospitalized RVGE in children less than 5 years of age -Distribution of body temperature among severe RVGE / hospitalized RVGE in children less than 5 years of age -Distribution of the genotypes of RV among hospitalized and severe RVGE in children less than 5 years of age -Incidence of severe and hospitalized RVGE of data collection period -Incidence of severe and hospitalized AGE of data collection period -Incidence of all AGE and all hospitalization of data collection period

—

Countries

Japan

Contacts

Public Contact* *

Shibata RVGE Study Secretariate

naka@mcp.co.jp03-3261-7326

Outcome results