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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042416
Receipt No. R000048418
Scientific Title A survey on data collection of infants (1)
Date of disclosure of the study information 2020/11/30
Last modified on 2020/11/11

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Basic information
Public title A survey on data collection of infants (1)
Acronym A survey on data collection of infants (1)
Scientific Title A survey on data collection of infants (1)
Scientific Title:Acronym A survey on data collection of infants (1)
Region
Japan

Condition
Condition Healthy children
Classification by specialty
Not applicable Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate children's walking behavior in daily life
Basic objectives2 Others
Basic objectives -Others Acquisition of basic knowledge through video collection and behavior analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gait data obtained from the collected videos
Key secondary outcomes Developmental indicators of infants obtained by questionnaires

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Shooting two types of walking videos a day
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
48 months-old >=
Gender Male and Female
Key inclusion criteria Healthy male and female infants who can walk independently
Key exclusion criteria - Infants with chronic diseases
- Infants born prematurely
-Infants deemed inappropriate to participate in this study by the principle investigator
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Motoki
Middle name
Last name Sudo
Organization Kao Corporation
Division name Personal Health Care Products Research
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL +81-080-8866-6133
Email sudou.motoki@kao.com

Public contact
Name of contact person
1st name Haruna
Middle name
Last name Asano
Organization Kao Corporation
Division name Personal Health Care Products Research
Zip code 131-8501
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL +81-080-4057-1543
Homepage URL
Email asano.haruna@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

Funding Source
Organization Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Human Research Ethics Committee, Kao Corporation
Address 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
Tel +81-3-5630-7263
Email morisaki.naoko@kao.com

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 花王株式会社(東京都)

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 30 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
2020 Year 11 Month 05 Day
Date of IRB
2020 Year 11 Month 05 Day
Anticipated trial start date
2020 Year 11 Month 30 Day
Last follow-up date
2021 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 11 Month 11 Day
Last modified on
2020 Year 11 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048418

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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