UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038525 |
|---|---|
| Receipt number | 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 | 2022/05/20 14:06:56 |
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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
skin_research@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Risa |
| Middle name | |
| Last name | Fukuda |
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
skin_research@ncchd.go.jp
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
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
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
50
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
No longer 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
| 2022 | Year | 05 | Month | 20 | Day |
Link to view the page
Value
https://center6.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 | |
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| Registered date | File name |
