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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000013260
Receipt No. R000014285
Scientific Title Effects of moisturizing skin care from the neonatal stage for improving skin barrier function and preventing skin trouble
Date of disclosure of the study information 2014/03/01
Last modified on 2018/02/27

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Basic information
Public title Effects of moisturizing skin care from the neonatal stage for improving skin barrier function and preventing skin trouble
Acronym Effects of moisturizing care from the neonatal stage
Scientific Title Effects of moisturizing skin care from the neonatal stage for improving skin barrier function and preventing skin trouble
Scientific Title:Acronym Effects of moisturizing care from the neonatal stage
Region
Japan

Condition
Condition Skin barrier function, diaper dermatitis, skin trouble (seborrheic dermatitis, eczema, dry skin)
Classification by specialty
Dermatology Nursing Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate moisturizing skin care on improvement of a skin barrier function and prevention of skin trouble.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Skin barrier function (transepidermal water loss, stratum corneum fluid, skin pH, sebum) when participants are three month old.
Key secondary outcomes (In the first 3 months of life)The score of The Neonatal Skin Condition Score (NSCS) and Diaper rash and erythema scoring scale , skin texture, cost of skin care, mother's QOL and anxiety
(Two years old) Food allergy, Atopic dermatitis, Asthma

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Intervention group (skin care group A)
Administer moisturizing skin care to the baby after discharge (5-8 days of age) from the hospital until three months of age.
Details of moisturizing skin care: Give the baby a bath with body soap less than once per two days and use moisturizing lotion three times a day.
A researcher individually inform the mothers how to care for their babies' skin. Mothers select body soap (one from two types) and moisturizing lotion (one from two types).
Interventions/Control_2 Control group (skin care group B)
Do not administer moisturizing skin care after discharge (5-8 days of age) from the hospital until three months of age.
Details of care: Give the baby a bath with body soap every day and do not use moisturizing lotion.
A researcher individually inform the mothers how to care for their babies' skin. Mothers select body soap (one from two types, as in the intervention group).
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
0 years-old <=
Age-upper limit
0 years-old >=
Gender Male and Female
Key inclusion criteria Newborn who is under 3-days-old and the 35-42 week gestational age neonate.
Newborn whose parents are Asian.
Key exclusion criteria Newborn who needs medical treatment at four days after birth.
Newborn whose mother is illiterate in Japanese.
Target sample size 284

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Megumi Haruna
Organization Graduate School of Medicine, The University of Tokyo
Division name Division of Health Science & Nursing
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-5841-3396
Email mharuna-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kaori Yonezawa
Organization Graduate School of Medicine, The University of Tokyo
Division name Division of Health Science & Nursing
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo
TEL 03-5841-3396
Homepage URL
Email kaori-512@umin.ac.jp

Sponsor
Institute Department of Midwifery and Women's Health
Institute
Department

Funding Source
Organization The Mitsubishi Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://onlinelibrary.wiley.com/doi/10.1111/1346-8138.14080/full
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 Main results already published
Date of protocol fixation
2013 Year 12 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
2018 Year 02 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 25 Day
Last modified on
2018 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014285

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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