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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037586
Receipt No. R000042846
Scientific Title A diaper wearing test C02
Date of disclosure of the study information 2019/08/02
Last modified on 2020/01/31

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Basic information
Public title A diaper wearing test C02
Acronym A diaper wearing test
Scientific Title A diaper wearing test C02
Scientific Title:Acronym A diaper wearing test C02
Region
Japan Asia(except Japan)

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

Objectives
Narrative objectives1 Motion analysis of infants
Basic objectives2 Others
Basic objectives -Others Analysis of influence on motion of an infant when wearing some diapers
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Motion analysis of an infant wearing a diaper
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 1.Putting reflective markers on infant's body.
2.Perform the specified operation in the specified area in a state of wearing three kinds of each diaper or naked.
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
18 years-old <=
Age-upper limit
20 years-old >=
Gender Male and Female
Key inclusion criteria 1.Healthy male and female infant. (18 months to 20 months old)
2.The infant who is living in Shanghai and can visit the test site with parental authority.
3.Body weight;9-14kg
4.The infant who can walk alone.
5.The infant using L-size pants-type diaper.
Key exclusion criteria 1. The infant who have been diagnosed by a doctor as having problems with walking (including those under treatment).
2. The infant who cannot cooperate with videotaping for this test (including naked walking).
3. The infant with dermatitis or allergies.
4. The infant with chronic sickness.
5. The infant has an infective disease.
6. The infant who dislikes measurement excessively.
7. The infant reluctant to wear a hat.
8. The infant who is prone to get rash due to adhesion.
9. In the case of parental authority of the target infant takes in the following occupations.
-Market Research / Marketing department of the manufacturer / Advertising agency.
-Press (TV / Radio / Newspaper / Magazine).
-Specialty stores of baby goods (excluding part-time jobs).
-Manufacturers, research, and sales (retail stores, wholesalers, distribution, etc.) related to sanitary products.
10. Preterm infants.
11. The infant who is judged to be unsuitable as a target of this test by the stuff in charge.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Yasuyuki
Middle name
Last name Okuda
Organization Kao Corporation
Division name Sanitary Products Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7432
Email okuda.yasuyuki@kao.com

Public contact
Name of contact person
1st name Kyoko
Middle name
Last name Tsuge
Organization Kao Corporation
Division name Sanitary Products Research
Zip code 321-3497
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL 0285-68-7379
Homepage URL
Email tsuge.kyoko@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 +81-3-5630-9861
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 上海交通大学(中国)

Other administrative information
Date of disclosure of the study information
2019 Year 08 Month 02 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 30
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 No longer recruiting
Date of protocol fixation
2019 Year 07 Month 17 Day
Date of IRB
2019 Year 07 Month 17 Day
Anticipated trial start date
2019 Year 08 Month 06 Day
Last follow-up date
2019 Year 12 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
2019 Year 08 Month 02 Day
Last modified on
2020 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042846

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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