UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062341 |
|---|---|
| Receipt number | R000071344 |
| Scientific Title | Development of The Japaneses version fo Short Forms of the Preschool Life Impact Burn Recovery Evaluation 1 to 5 years |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2026/07/26 18:27:34 |
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Basic information
Public title
Development of The Japaneses version fo Short Forms of the Preschool Life Impact Burn Recovery Evaluation 1 to 5 years
Acronym
Preschool LIBRE Profile-SF study in Japan
Scientific Title
Development of The Japaneses version fo Short Forms of the Preschool Life Impact Burn Recovery Evaluation 1 to 5 years
Scientific Title:Acronym
Preschool LIBRE Profile-SF study in Japan
Region
| Japan |
Condition
Condition
Burn injuries
Classification by specialty
| Surgery in general | Pediatrics | Plastic surgery |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop the Japanese version of Preschool Life Impact Burn Recovery Evaluation profile short form for 1-5 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The validity and relaiability of the Japnese version of Preschool LIBRE profile-SF
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
| 5 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children who meet the following conditions, along with their legal guardians and caregivers:
1) Children between the ages of 1 and 5 (including 1 and 5) at the time of evaluation
2) Children who have sustained a burn injury (regardless of the burn area or location)
3) Children who have completed inpatient treatment and been discharged from the hospital at the time of evaluation
4) Leagl guardians and caregivers who speak and understand Japanese and reside in Japan
Key exclusion criteria
Participants who meet the above selection criteria but for whom guardians consent to participate in this study could not be obtained. Participants who could not be contacted during the study and for whom questionnaires could not be sent or collected.
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Sato |
Organization
Keio University School of Medicine
Division name
The Department of Emergency and Critical Care Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
+81-3-3225-1323
yukiosato.a6@keio.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Sato |
Organization
Keio University School of Medicine
Division name
Department of Emergency and Critical Care Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
+81-3-3225-1323
Homepage URL
yukiosato.a6@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Self-sourcing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
+81-3-3353-1211
med-rinri-jimu@adst.keio.ac.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
| 2026 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The analysis of answers for profile
Management information
Registered date
| 2026 | Year | 07 | Month | 26 | Day |
Last modified on
| 2026 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071344
