UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045600 |
|---|---|
| Receipt number | R000052065 |
| Scientific Title | A diaper wearing test S01 |
| Date of disclosure of the study information | 2021/09/29 |
| Last modified on | 2021/09/29 16:57:47 |
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Basic information
Public title
A diaper wearing test
Acronym
A diaper wearing test
Scientific Title
A diaper wearing test S01
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
Study of infant sleep
Basic objectives2
Others
Basic objectives -Others
Analysis of the effect of two types of diapers on infant sleep
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of an infant sleep wearing a diaper
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Wear sample diapers A at bedtime for infants for 5 days.->1 week ->Wear sample diapers B at bedtime for infants for 5 days.
During sleep, wear a heart rate meter, activity meter, and thermohygrometer and take a picture with an infrared camera.
Interventions/Control_2
Wear sample diapers B at bedtime for infants for 5 days.->1 week ->Wear sample diapers A at bedtime for infants for 5 days.
During sleep, wear a heart rate meter, activity meter, and thermohygrometer and take a picture with an infrared camera.
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
| 36 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Healthy male and female infant. (6 months to 36 months old)
2. The infant who sleep alone.
3. Infants using M or L size disposable diapers during the test.
Key exclusion criteria
1. Infants weighing less than 2500 g at birth.
2. Infants with a gestation period of less than 36 weeks or more than 42 weeks.
3. Infants who do not sleep for more than 30 minutes after crying badly breastfeeding or changing diapers
4. Infants with asthma in children.
5. Infants with severe dermatitis and other skin symptoms.
6. Infants with atopic dermatitis.
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Fukuda |
Organization
Kao Corporation
Division name
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 | Keisuke |
| Middle name | |
| Last name | Koizumi |
Organization
Kao Corporation
Division name
Sanitary Products Research
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
070-3300-8549
Homepage URL
koizumi.keisuke@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（栃木県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 29 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2021 | 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
| 2021 | Year | 09 | Month | 29 | Day |
Last modified on
| 2021 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052065
