UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035412 |
|---|---|
| Receipt number | R000040348 |
| Scientific Title | Effect of change in bathing and skin care in infancy on the incidence of eczema at 6 months of age |
| Date of disclosure of the study information | 2019/01/07 |
| Last modified on | 2022/07/05 17:08:45 |
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Basic information
Public title
Effect of change in bathing and skin care in infancy on the incidence of eczema at 6 months of age
Acronym
Skin care in early infancy and eczema incidence
Scientific Title
Effect of change in bathing and skin care in infancy on the incidence of eczema at 6 months of age
Scientific Title:Acronym
Skin care in early infancy and eczema incidence
Region
| Japan |
Condition
Condition
eczema
Classification by specialty
| Pediatrics | Dermatology | Nursing |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparing eczema incidence of baby between parents are instructed conventional skin care and skin care emphasized cleaning and moisturizing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Eczema prevalence at 6 months of age
Based on UKWP criteria
Key secondary outcomes
(1) Total epithelial water loss (TEWL)
(2) Adherence to skin care method instructed
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
New method
Give a bath the temperature of water is 38 to 39 degrees. Wash face, head and all of a body using hands with soap bubbles.
At first, wash out soap by bathwater.
Next, wash out soap completely by shower after drained the bathtub.
Dry baby with towel gently, do not wipe.
And moisturize all of the body included baby's face on the basis of fingertip unit techniques. Moisturizing lotion is in the patient's room and it can be used at
any time. We direct to moisturize baby after discharge from hospital.
It is free which they use moisturizing agent.
Interventions/Control_2
Conventional method
Give a bath the temperature of water is 38 to 39 degrees. Wash a body and head using hands with soap bubbles.
Do not use soap for washing a face but use a wet gauze. Wash out bubbles by
bathwater, not use a shower. Dry baby with towel gently, do not moisturize baby.
We direct to continue same method until 1month old. After that, they can care baby free. We do not instruct about soaps and moisturizing.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The babies who are born at the chiba university hospital and whose born weight is suitable from 2500g to 4000g. It is needed they are term infant. It does not matter what kind of Delivery style and family structure.
Key exclusion criteria
(1) A baby is needed to care in NICU.
(2) Parents cannot read, write and speak Japanese well.
(3) Parents are under the age of 20.
(4) When a study request may lead to the physical psychological burden on child or parents.
(5) When investigator or cooperator judge the case is unsuitable for the study.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Shimojo |
Organization
Chiba University
Division name
Department of Pediatrics
Zip code
2600856
Address
1-8-1, Inohana, Chuo-ku chiba-shi, Chiba, 260-0856, JAPAN
TEL
043-222-7171
shimojo@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Shimojo |
Organization
Chiba University
Division name
Department of Pediatrics
Zip code
2600856
Address
1-8-1, Inohana, Chuo-ku chiba-shi, Chiba, 260-0856, JAPAN
TEL
043-222-7171
Homepage URL
shimojo@faculty.chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Minister of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the Chiba University hospital
Address
1-8-1, Inohana, Chuo-ku chiba-shi, Chiba, 260-0856, JAPAN
Tel
043-222-7171
igaku-koho@chiba-u.jp
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 07 | 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
279
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Delay in data analysis
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
| 2019 | Year | 01 | Month | 06 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 30 | Day |
Last modified on
| 2022 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040348
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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