UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013260 |
|---|---|
| Receipt number | 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 16:24:36 |
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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
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
kaori-512@umin.ac.jp
Sponsor or person
Institute
Department of Midwifery and Women's Health
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014285
