UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021719 |
|---|---|
| Receipt number | R000025039 |
| Scientific Title | Depth of mid-anterolateral thigh muscle in Japanese children for the safety of intramuscular injection. |
| Date of disclosure of the study information | 2016/03/31 |
| Last modified on | 2022/10/05 16:56:00 |
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Basic information
Public title
Depth of mid-anterolateral thigh muscle in Japanese children for the safety of intramuscular injection.
Acronym
Depth of mid-anterolateral thigh muscle in Japanese children.
Scientific Title
Depth of mid-anterolateral thigh muscle in Japanese children for the safety of intramuscular injection.
Scientific Title:Acronym
Depth of mid-anterolateral thigh muscle in Japanese children.
Region
| Japan |
Condition
Condition
The patients with anaphylaxis caused by food, and healthy participants.
Classification by specialty
| Clinical immunology | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the needle length adequacy of epinephrine auto-injectors (epipen (r))0.15mg for the infants, especially less than 15 kg.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Whether the needle length (12.7mm) is between the skin-to-muscle depth and skin-to-bone depth under minimal and maximal pressure or not.
Key secondary outcomes
Whether we can predict the participants who fit the length of the needle by using body hight, body weight, Kaup index and circumstance of thigh.
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
| 15 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Body weight less than 20kg
Key exclusion criteria
Diseases with some effect for femoral size
Gait disorder
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Norio |
| Middle name | |
| Last name | Kawamoto |
Organization
Gifu University Hospital
Division name
Department of Pediatrics
Zip code
501-1194
Address
1-1 Yanagido, Gifu, 501-1194, Japan
TEL
+81-58-230-6000
noriok-gif@umin.ac.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Kawamoto |
Organization
Gifu University Hospital
Division name
Department of Pediatrics
Zip code
501-1194
Address
1-1 Yanagido, Gifu, 501-1194, Japan
TEL
+81-58-230-6000
Homepage URL
noriok-gif@umin.ac.jp
Sponsor or person
Institute
Gifu University
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu University Hospital
Address
1-1 Yanagido, Gifu, 501-1194, Japan
Tel
+81-58-230-6386
noriok@gifu-u.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
| 2016 | Year | 03 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Skin-to-muscle depth and skin-to-bone depth measurements were performed by ultrasounds of the mid-anterolateral thigh under minimal and maximal pressure. Compared these depth with body weight, body hight, Kaup index, circumstance of mid-thigh.
Management information
Registered date
| 2016 | Year | 03 | Month | 31 | Day |
Last modified on
| 2022 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025039
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
