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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000023439
Receipt No. R000025683
Scientific Title A multicenter prospective observational study to investigate applicability of the PECARN rule in Japanese children
Date of disclosure of the study information 2016/08/02
Last modified on 2016/08/02

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Basic information
Public title A multicenter prospective observational study to investigate applicability of the PECARN rule in Japanese children
Acronym A multicenter prospective observational study to investigate applicability of the PECARN rule in Japanese children
Scientific Title A multicenter prospective observational study to investigate applicability of the PECARN rule in Japanese children
Scientific Title:Acronym A multicenter prospective observational study to investigate applicability of the PECARN rule in Japanese children
Region
Japan

Condition
Condition minor head trauma
Classification by specialty
Pediatrics Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate applicability of the PECARN rule with mild head trauma in Japanese children
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Clinically important traumatic brain injury
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
0 years-old <=
Age-upper limit
16 years-old >
Gender Male and Female
Key inclusion criteria Children who presented to the emergency department within 24 hours of injury
Key exclusion criteria Children older than 16-year-old
Children with an initial Glasgow Coma Scale less than 14 at the emergency department
Children with neruroimaging performed at another hospital before transfer
Children who refused to participate in the study
Target sample size 5400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoko Uematsu
Organization National Center for Child Health and Development
Division name Divison of Pediatric Emergency and Transport Survices
Zip code
Address 2-10-1, Okura, Setagaya-ku, Tokyo,157-8535, Japan
TEL 03-3416-0181
Email uematsu-st@ncchd.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Ide
Organization National Center for Child Health and Development
Division name Division of Critical Care Medicine
Zip code
Address 2-10-1, Okura, Setagaya-ku, Tokyo,157-8535, Japan
TEL 03-3416-0181
Homepage URL
Email ide-k@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science, and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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
2016 Year 08 Month 02 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
Date of protocol fixation
2016 Year 04 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 05 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Demographic characteristics,
past medical history and medication,
time of injury,
time of ED attendance,
detailed mechanism of injury,
site of trauma,
features and onset of posttraumatic symptoms, mental status, Observation time before CT scan and/or discharge from ER, CT scan findings, need for neurosurgery procedure or hospitalization over 2nights because of the brain injury, need for mechanical respiratory treatments over 24 hours, results of scheduled and unscheduled return visits, and reports of the institutional Suspected Child Abuse and Neglect Team.

Management information
Registered date
2016 Year 08 Month 02 Day
Last modified on
2016 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025683

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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