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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021719
Receipt No. 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 2020/10/03

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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
Email 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
Email noriok-gif@umin.ac.jp

Sponsor
Institute Gifu University
Institute
Department

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
Email 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
2021 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
2020 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025039

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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