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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name