UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042416 |
|---|---|
| Receipt number | 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 11:46:16 |
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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
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
asano.haruna@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048418
