UMIN-CTR Clinical Trial

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

Healthy children.

Classification by specialty

Medicine in general	Infectious disease	Pediatrics
Child

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

kntsh@luke.ac.jp

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

Email

leoking168@thekingclinic.com

Institute

St. Luke's International Hospital

Institute

Department

Personal name

Organization

n/a

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

聖路加国際病院

Date of disclosure of the study information

2015

Year

09

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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