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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035412
Receipt No. 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 2019/01/10

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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
Last name of lead principal investigator
1st name
Middle name
Last name Naoki Shimojo
Organization Chiba University
Division name Department of Pediatrics
Zip code
Address 1-8-1, Inohana, Chuo-ku chiba-shi, Chiba, 260-0856, JAPAN
TEL 043-222-7171
Email shimojo@faculty.chiba-u.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Naoki Shimojo
Organization Chiba University
Division name Department of Pediatrics
Zip code
Address 1-8-1, Inohana, Chuo-ku chiba-shi, Chiba, 260-0856, JAPAN
TEL 043-222-7171
Homepage URL
Email shimojo@faculty.chiba-u.jp

Sponsor
Institute Chiba University
Institute
Department

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
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 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
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 Enrolling by invitation
Date of protocol fixation
2019 Year 01 Month 06 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 30 Day
Last modified on
2019 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040348

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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