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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000016520
Receipt No. R000011271
Scientific Title 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.
Date of disclosure of the study information 2015/02/12
Last modified on 2021/08/25

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Basic information
Public title 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.
Acronym Shibata RVGE Study
Scientific Title 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.
Scientific Title:Acronym Shibata RVGE Study
Region
Japan

Condition
Condition severe rotavirus gastroenteritis
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the burden of severe rotavirus gastroenteritis (RVGE) before and after introduction of rotavirus vaccination in Shibata-City, Niigata Prefecture, Japan.
Basic objectives2 Others
Basic objectives -Others -To estimate the proportion of severe outpatient RVGE among severe acute gastroenteritis (AGE) or all AGE in children less than five years of age, following the introduction of RV vaccination in Japan
-To estimate the proportion of hospitalization related RVGE among all AGE in children less than five years of age, before and after the introduction of RV vaccination in Japan
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes -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
Key secondary outcomes -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

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit
5 years-old >
Gender Male and Female
Key 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
Key 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
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Hasegawa
Organization Niigata Prefectural Shibata Hospital
Division name Pediatric Department
Zip code 957-8588
Address 1-2-8, Hon-cho, Shibata-shi, Niigata
TEL 0254-22-3121
Email shasegawa.125@gmail.com

Public contact
Name of contact person
1st name *
Middle name
Last name *
Organization Shibata RVGE Study
Division name Secretariate
Zip code 102-0094
Address Shin kioi-cho Bldg., 4-1,Kioi-cho,Chiyoda-ku,Tokyo
TEL 03-3261-7326
Homepage URL
Email naka@mcp.co.jp

Sponsor
Institute Shibata RVGE Study
Institute
Department

Funding Source
Organization GlaxoSmithKline Vaccines R&D
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee Niigata Prefectural Shibata Hospital
Address 1-2-8, Hon-cho, Shibata-shi, Niigata
Tel 0254-22-3121
Email shasegawa.125@gmail.com

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 12 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications http://www.scirp.org/Journal/PaperInformation.aspx?PaperID=52025
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2012 Year 11 Month 13 Day
Date of IRB
2020 Year 04 Month 30 Day
Anticipated trial start date
2013 Year 01 Month 01 Day
Last follow-up date
2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective,observational, multicenter study to collect the severe outpatient RVGE/AGE data from the clinics and with retrospective data collection on the hospitalized RVGE/AGE in Shibata city in Japan

Management information
Registered date
2015 Year 02 Month 12 Day
Last modified on
2021 Year 08 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011271

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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