UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049207 |
|---|---|
| Receipt number | R000056045 |
| Scientific Title | Reanalysis of diaper wearing test S01 |
| Date of disclosure of the study information | 2022/10/13 |
| Last modified on | 2026/01/20 17:41:18 |
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Basic information
Public title
Reanalysis of diaper wearing test
Acronym
Reanalysis of diaper wearing test
Scientific Title
Reanalysis of diaper wearing test S01
Scientific Title:Acronym
Reanalysis of 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
Study of infant sleep
Basic objectives2
Others
Basic objectives -Others
Develop programs to determine sleep and wakefulness. Using the developed program, we will analyze the effect on sleep when wearing two types of diapers.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of an infant sleep wearing a diaper
Key secondary outcomes
Development of programs to determine sleep and wakefulness
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| 6 | months-old | <= |
Age-upper limit
| 12 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants who participated in the "Diaper Wearing Test S01" and agreed to the storage and use of data including videos for 10 years (on behalf of their guardians).
Key exclusion criteria
None
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Fukuda |
Organization
Kao Corporation
Division name
ResearchR&D -Development Research -Sanitary Products Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7285
fukuda.yuuko1@kao.com
Public contact
Name of contact person
| 1st name | Tamami |
| Middle name | |
| Last name | Watanabe |
Organization
Kao Corporation
Division name
ResearchR&D -Development Research -Sanitary Products Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7284
Homepage URL
watanabe.tamami2@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
Ritsumeikan University
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（栃木県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 13 | 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
| 2022 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Develop programs to determine sleep and wakefulness. Using the developed program, we will analyze the effect on sleep when wearing two types of diapers.
Management information
Registered date
| 2022 | Year | 10 | Month | 13 | Day |
Last modified on
| 2026 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056045
