UMIN-CTR Clinical Trial

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
Email	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
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	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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040348