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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038525
Receipt No. R000043888
Scientific Title Analysis of infantile tritium corneum barrier factor and breast milk factor
Date of disclosure of the study information 2019/11/08
Last modified on 2019/11/07

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Basic information
Public title Analysis of infantile tritium corneum barrier factor and breast milk factor
Acronym Analysis of infantile tritium corneum barrier factor and breast milk factor
Scientific Title Analysis of infantile tritium corneum barrier factor and breast milk factor
Scientific Title:Acronym Analysis of infantile tritium corneum barrier factor and breast milk factor
Region
Japan

Condition
Condition neonates
Classification by specialty
Dermatology Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To Analyze the factors in breast milk that are thought to be involved in atopic dermatitis in infants at the same time as the stratum corneum components, and searches for the relationship between them.
Basic objectives2 Others
Basic objectives -Others To investigate water content, stratum corneum components, and skin barrier function that change with growth from the neonatal period
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Water content of stratum corneum and specific molecules (natural moisturizing factor, urea, urocanic acid, ceramide, cholesterol, etc.) measured by confocal Raman spectroscopy.
Key secondary outcomes 2. Stratum corneum pH
3. Water content of stratum corneum
4. TEWL
5. breast milk factor (TGF-beta1, TGF-beta2,IgA, lactoferrin)

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
1 days-old <=
Age-upper limit
7 days-old >=
Gender Male and Female
Key inclusion criteria Among those who satisfy all of the following and do not meet any of the exclusion criteria, those who have consented to this study.
(1) A child born at the National Center for Child Health and Development (or planning) and their mother
(2) Less than one week after birth
Key exclusion criteria (1) Parents cannot understand Japanese
(2) Children with obvious serious underlying disease
(3) Any other person deemed to be inappropriate by the attending physician
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kazue
Middle name
Last name Yoshida
Organization National Center for Child Health and Development
Division name Division of Dermatology
Zip code 157-8535
Address 2-10-1, Okura, Setagayaku, Tokyo 157-8535
TEL 03-3416-0181
Email skin_research@ncchd.go.jp

Public contact
Name of contact person
1st name Naoko
Middle name
Last name Mochimaru
Organization National Center for Child Health and Development
Division name Division of Dermatology
Zip code 157-8535
Address 2-10-1, Okura, Setagayaku, Tokyo 157-8535
TEL 03-3416-0181
Homepage URL
Email skin_research@ncchd.go.jp

Sponsor
Institute National Center for Child Health and Development
Institute
Department

Funding Source
Organization Pigeon corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Center for Child Health and Development
Address 2-10-1, Okura, Setagayaku, Tokyo 157-8535
Tel 03-3416-0181
Email rinri@ncchd.go.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

Other administrative information
Date of disclosure of the study information
2019 Year 11 Month 08 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 Open public recruiting
Date of protocol fixation
2019 Year 07 Month 02 Day
Date of IRB
2019 Year 07 Month 02 Day
Anticipated trial start date
2019 Year 07 Month 02 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In addition to measuring the stratum corneum factor and breast milk factor, conduct surveys (basic attributes of the person and family, medical history, family history, pregnancy / birth history, medical history, nutritional diet, drugs, skin care methods, etc.).

Management information
Registered date
2019 Year 11 Month 08 Day
Last modified on
2019 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043888

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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