UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012115 |
|---|---|
| Receipt number | R000014146 |
| Scientific Title | Elucidation of pathogenesis and surveillance of rotavirus infection associated encephalopathy, sudden unexpected death, gastrointestinal bleeding and urinary tract stone cases in Aichi Prefecture |
| Date of disclosure of the study information | 2013/10/25 |
| Last modified on | 2018/10/29 07:53:28 |
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Basic information
Public title
Elucidation of pathogenesis and surveillance of rotavirus infection associated encephalopathy, sudden unexpected death, gastrointestinal bleeding and urinary tract stone cases in Aichi Prefecture
Acronym
Elucidation of pathogenesis and surveillance of rotavirus infection severe cases in Aichi Prefecture
Scientific Title
Elucidation of pathogenesis and surveillance of rotavirus infection associated encephalopathy, sudden unexpected death, gastrointestinal bleeding and urinary tract stone cases in Aichi Prefecture
Scientific Title:Acronym
Elucidation of pathogenesis and surveillance of rotavirus infection severe cases in Aichi Prefecture
Region
| Japan |
Condition
Condition
Rotavirus infection
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidation of frequency and pathogenesis of severe complications caused by
rotavirus infection such as encephalopathy, sudden unexpected death,
gastrointestinal bleeding, and urinary tract stone.
Basic objectives2
Others
Basic objectives -Others
Epidemiology and pathogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. The incidence of severe complications caused by rotavirus infection such
as encephalopathy, sudden unexpected death, gastrointestinal bleeding, and
urinary tract stone.
2. Trends in frequency of rotavirus infection associated severe complication
after introduction of rotavirus vaccine.
3. Elucidation of pathogenesis of severe complication caused by rotavirus
infection.
Key secondary outcomes
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
| 1 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases with severe complications caused by
rotavirus infection such as encephalopathy, sudden unexpected death,
gastrointestinal bleeding, and urinary tract stone in Aichi prefecture, Japan.
Key exclusion criteria
Children in the exception of Aichi.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Kawamura |
Organization
Fujita Health University School of Medicine
Division name
Pediatrics
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho Toyoake city Aichi 470-1192 Japan
TEL
0562-93-9251
kyoshiki3@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiki Kawamura |
Organization
Fujita Health University School of Medicine
Division name
Pediatrics
Zip code
Address
1-98 Dengakugakubo Kutsukake-cho Toyoake city Aichi 470-1192 Japan
TEL
0562-93-9251
Homepage URL
kyoshiki3@hotmail.com
Sponsor or person
Institute
Fujita Health University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
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
| 2013 | Year | 10 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 29 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 29 | Day |
Date trial data considered complete
| 2018 | Year | 10 | Month | 29 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 29 | Day |
Other
Other related information
There is no information for the preinitiation.
Management information
Registered date
| 2013 | Year | 10 | Month | 24 | Day |
Last modified on
| 2018 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014146
