UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A multicenter prospective observational study to investigate applicability of the PECARN rule in Japanese children
Title of the study (Brief title)	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	Satoko Uematsu
Organization	National Center for Child Health and Development
Division name	Divison of Pediatric Emergency and Transport Survices
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	Kentaro Ide
Organization	National Center for Child Health and Development
Division name	Division of Critical Care Medicine
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 04 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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