UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023439 |
|---|---|
| Receipt number | 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 07:19:45 |
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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
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
ide-k@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
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
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
Value
https://center6.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 |
