UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018799 |
|---|---|
| Receipt number | R000021752 |
| Scientific Title | Fat pad thickness measured using B-mode ultrasonography in small children below 2 year old: safety measures in intramuscular vaccination amongst Japanese children. |
| Date of disclosure of the study information | 2015/09/10 |
| Last modified on | 2015/09/14 15:58:53 |
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Basic information
Public title
Fat pad thickness measured using B-mode ultrasonography in small children below 2 year old: safety measures in intramuscular vaccination amongst Japanese children.
Acronym
Measurement of fat pad and muscle thickness amongst Japanese children for the safety of intramuscular vaccination.
Scientific Title
Fat pad thickness measured using B-mode ultrasonography in small children below 2 year old: safety measures in intramuscular vaccination amongst Japanese children.
Scientific Title:Acronym
Measurement of fat pad and muscle thickness amongst Japanese children for the safety of intramuscular vaccination.
Region
| Japan |
Condition
Condition
Healthy children.
Classification by specialty
| Medicine in general | Infectious disease | Pediatrics |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To obtain appropriate data amongst Japanese population regarding the thickness of the muscle and fat pad thickness at the site of intramuscular immunization below 2 year old.
Basic objectives2
Others
Basic objectives -Others
To figure out the appropriate length of needle for the small children in Japan.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
This study will confirm if the CDC recommendation would be appropriate for the general Japanese small children population regarding the intramuscular immunization practices, especially concerning the needle length advised to be used.
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 | months-old | <= |
Age-upper limit
| 24 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Both genders below and including 24 month old, without major swelling and/or inflammatory conditions in the lower extremities and without excessive malnutrition. The measurements will be performed to healthy infants and children that meet the criteria, visiting our facility for check-up, vaccination, or other consultations. Born above 1500g at age. Guardian that can understand independently about the written consent. Economic status does not segregate condition. Minimum interval for each measurement will be at least 4 weeks. All measurements are done as outpatients. Use of therapeutic drugs will not alter joining.
Key exclusion criteria
Children born under 1500g. Malnutrition child. Children free from malignancy, acute/severe illnesses, local skin swelling or dermatological conditions. Children of whom born under someone unable to understand the purpose of this study. Children above 25 month old. Anyone arriving before 4 weeks after the prior measurement. Children suffering from domestic violence of other conditions that the physician/pediatrician thinks inappropriate for the study. Non-asian population.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Kon (Leo A. T. King), M.D. |
Organization
St. Luke's International Hospital
Division name
St. Luke's MediLocus
Zip code
Address
South Tower 2F, 1-9-7, Otemachi, Chiyoda-ku, Tokyo
TEL
03-3409-0764
kntsh@luke.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Leo A. T. King, M.D. |
Organization
THE KING CLINIC
Division name
DIRECTOR GENERAL
Zip code
Address
6-31-11, JINGUMAE, SHIBUYA-KU, TOKYO
TEL
03-3409-0764
Homepage URL
leoking168@thekingclinic.com
Sponsor or person
Institute
St. Luke's International Hospital
Institute
Department
Personal name
Funding Source
Organization
n/a
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
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
聖路加国際病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 10 | 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
| 2015 | Year | 09 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not started yet.
Measurements of:
- Age and gender
- Height
- Weight
- Body mass index
- Circumference of the mid-thigh (bilateral)
- Thickness of subcutaneous fat, tissue (including the vast us lateralis muscle) of the mid-thigh using conventional ultrasound in B-mode.
Management information
Registered date
| 2015 | Year | 08 | Month | 25 | Day |
Last modified on
| 2015 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021752
