UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032964 |
|---|---|
| Receipt number | R000037591 |
| Scientific Title | Skin tension of scalp in infants |
| Date of disclosure of the study information | 2018/06/14 |
| Last modified on | 2020/12/14 12:12:07 |
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Basic information
Public title
Skin tension of scalp in infants
Acronym
Skin tension of scalp in infants
Scientific Title
Skin tension of scalp in infants
Scientific Title:Acronym
Skin tension of scalp in infants
Region
| Japan | Europe |
Condition
Condition
The patients who performed via coronal incision
Classification by specialty
| Neurosurgery | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to evaluate the validity of distraction osteogenesis, we investigate the difference in extension of scalp of infants between races.
Basic objectives2
Others
Basic objectives -Others
In order to evaluate the validity of distraction osteogenesis, we investigate the difference in extension of scalp of infants between races.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Skin tension of the scalp
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
| 6 | months-old | <= |
Age-upper limit
| 13 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who is performed via coronal incision
Key exclusion criteria
Patients who were previously performed via coronal incision
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kazuo |
| Middle name | |
| Last name | Kishi |
Organization
Keio University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku
TEL
+81353633814
kkishi@a7.keio.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Sakamoto |
Organization
Keio University School of Medicine
Division name
Department of Plastic and Reconstructive Surgery
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku
TEL
+81353633814
Homepage URL
ysakamoto@z8.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Osaka City General Hospital
Hopital Necker Enfants Malades
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel
0333531211
ysakamoto@z8.keio.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
慶應義塾大学病院(東京都)、大阪市立総合医療センター(大阪府)、ネッカー小児病院(フランス、パリ)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 14 | 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 | 04 | Month | 27 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Skin tension of scalp in infants are measured.
Management information
Registered date
| 2018 | Year | 06 | Month | 13 | Day |
Last modified on
| 2020 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037591
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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