UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016520 |
|---|---|
| Receipt number | 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 | 2024/02/19 10:05:40 |
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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
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
naka@mcp.co.jp
Sponsor or person
Institute
Shibata RVGE Study
Institute
Department
Personal name
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
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
Completed
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
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
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
| 2024 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011271
