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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name