UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031961 |
|---|---|
| Receipt number | R000036497 |
| Scientific Title | The prospective observational multicenter study of injuries among children in Japan. |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2021/10/02 16:32:47 |
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Basic information
Public title
The prospective observational multicenter study of injuries among children in Japan.
Acronym
The Survey about injuries among children in Japan.
Scientific Title
The prospective observational multicenter study of injuries among children in Japan.
Scientific Title:Acronym
The Survey about injuries among children in Japan.
Region
| Japan |
Condition
Condition
injuries
Classification by specialty
| Pediatrics | Emergency medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We describe the epidemiological characteristics and situation of injuries among children in Japan.
Basic objectives2
Others
Basic objectives -Others
epidemiological characteristics
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
What type of severe injuries occur to children in Japan
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
| 16 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The cases with some injuries required admission or follow-up
Key exclusion criteria
The cases without assent from parents
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Kishibe |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Pediatric Emergency Medicine
Zip code
1838561
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
TEL
042-300-5111
jemstone625@gmail.com
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Kishibe |
Organization
Tokyo Metropolitan Children's Medical Center
Division name
Pediatric Emergency Medicine
Zip code
1838561
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
TEL
042-300-5111
Homepage URL
shun_kishibe@tmhp.jp
Sponsor or person
Institute
Tokyo Metropolitan Children's Medical Center
Institute
Department
Personal name
Funding Source
Organization
no organization
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
Tokyo Metropolitan Children's Medical Center
Address
2-8-29 Musashidai, Fuchu-shi, Tokyo, Japan
Tel
042-300-5111
shun_kishibe@tmhp.jp
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
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
no appreciable information
Management information
Registered date
| 2018 | Year | 03 | Month | 29 | Day |
Last modified on
| 2021 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036497
