UMIN-CTR Clinical Trial

Basic information
Public title	A diaper wearing test C01
Acronym	A diaper wearing test
Scientific Title	A diaper wearing test C01
Scientific Title:Acronym	A diaper wearing test
Region	Japan

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

Objectives
Narrative objectives1	Motion analysis of an infant wearing a diaper
Basic objectives2	Others
Basic objectives -Others	Analysis of motion of an infant wearing some diapers one of some types of 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 motion analysis markers and EMG sensors on skin 2.Perform the specified operation in the specified area with one of three types of diapers and without diaper.
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	12 months-old <=
Age-upper limit	30 months-old >
Gender	Male and Female
Key inclusion criteria	1.Healthy male and female infants (12 months to 30 months old) 2.Infants who live in the vicinity of Tokyo and can visit the test site with parental authority. 3.Body weight ; 9 ~ 14kg 4.Infants who can stand or walk alone. 5.Infants who use L size pants-type diaper.
Key exclusion criteria	1.Infants with chronic sickness. 2.Infants who have a severe skin trouble. 3.Infants who have an infective disease. 4.Infants who dislike measurement excessively. 5.Infants who are prone to get rash due to adhesion. 6.Parental authority is occupation of the target infant corresponds in the following. -Market Research/Marketing department of the manufacturer/Advertising agency -TV/Radio/Newspaper/Magazine media related -Specialty stores of baby goods(excluding part-time job) -Retail stores/Wholesalers/Distribution/Sales relations/sanitary products such as papermaking, paper processed products,sanitary products,diapers,etc. 7.Infants who are judged as a unsuitable test participant by the test staff.
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuyuki Okuda
Organization	Kao Corporation
Division name	Sanitary Products Research
Zip code
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 Middle name Last name Kyoko Tsuge
Organization	Kao Corporation
Division name	Sanitary Products Research
Zip code
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
Address
Tel
Email

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	2018 Year 12 Month 26 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	Completed
Date of protocol fixation	2018 Year 11 Month 29 Day
Date of IRB	2018 Year 11 Month 29 Day
Anticipated trial start date	2018 Year 12 Month 19 Day
Last follow-up date	2019 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 10 Month 05 Day

Other
Other related information

Management information
Registered date	2018 Year 12 Month 26 Day
Last modified on	2020 Year 10 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040304