UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Elucidation of pathogenesis and surveillance of rotavirus infection associated encephalopathy, sudden unexpected death, gastrointestinal bleeding and urinary tract stone cases in Aichi Prefecture
Title of the study (Brief title)	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	Yoshiki Kawamura
Organization	Fujita Health University School of Medicine
Division name	Pediatrics
Address	1-98 Dengakugakubo Kutsukake-cho Toyoake city Aichi 470-1192 Japan
TEL	0562-93-9251
Email	kyoshiki3@hotmail.com

Public contact
Name of contact person	Yoshiki Kawamura
Organization	Fujita Health University School of Medicine
Division name	Pediatrics
Address	1-98 Dengakugakubo Kutsukake-cho Toyoake city Aichi 470-1192 Japan
TEL	0562-93-9251
Homepage URL
Email	kyoshiki3@hotmail.com

Sponsor
Institute	Fujita Health University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014146