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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027834
Receipt No. R000031889
Scientific Title Investigating biomarkers for development of atopic dermatitis in early childhood using maternal-infant hair-related microRNA
Date of disclosure of the study information 2017/06/20
Last modified on 2019/08/09

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Basic information
Public title Investigating biomarkers for development of atopic dermatitis in early childhood using maternal-infant hair-related microRNA
Acronym Hair-related microRNA effects by fetal tobacco smoke exposure on the development of subsequent infantile eczema
Scientific Title Investigating biomarkers for development of atopic dermatitis in early childhood using maternal-infant hair-related microRNA
Scientific Title:Acronym Hair-related microRNA effects by fetal tobacco smoke exposure on the development of subsequent infantile eczema
Region
Japan

Condition
Condition Eczema
Classification by specialty
Clinical immunology Pediatrics Dermatology
Child
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 In a high-risk birth cohort in pregnant mothers with eczema, we clarify transgenereationalmechanisum of fetal tobacco smoke exposure effects on the development of eczema using hair-related microRNA (miRNA).
Basic objectives2 Others
Basic objectives -Others Using hair-related miRNA as a biomarker for the development of eczema.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Exploration of transgenerational hair-related miRNA
Key secondary outcomes kinds of hair-related miRNA

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
18 years-old <=
Age-upper limit
35 years-old >
Gender Male and Female
Key inclusion criteria *Pregnant women (>= 28 gestation weeks)
*Pregnant mother and father with allergic diseases
*Pregnant mother and father without allergic diseases
Key exclusion criteria *Pregnant mother with using medication
*Pregnant mother and father with chronic diseases, expect allergic diseases
*Pregnant mother who do not want avoid smoking
*Infants who born by cesarean section
*Premature infants
*Infants with with chronic diseases, expect allergic diseases
*Invidivuals with using supplements including vitamine
*Individuales with judgement of ineligible by a responsible researcher
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Miwa
Middle name
Last name Shinohara
Organization Juntendo University, Faculty of Medicine
Division name Department of Pediatrics
Zip code 113-0033
Address Department of Pediatrics
TEL 03-3813-3111
Email mi-shinohara@juntendo.ac.jp

Public contact
Name of contact person
1st name Miwa
Middle name
Last name Shinohara
Organization Juntendo University, Faculty of Medicine
Division name Department of Pediatrics
Zip code 113-0033
Address 3-1-3 Hongo, Bunkyo-ku TOKYO, 113-0033, JAPAN
TEL 03-3813-3111
Homepage URL
Email mi-shinohara@juntendo.ac.jp

Sponsor
Institute Departments of Pediatrics
Juntendo University, Faculty of Medicine
3-1-3 Hongo, Bunkyo-ku
TOKYO, 113-0033, JAPAN
TEL +81-3-3813-3111
FAX +81-3-5800-1580
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research (KAKENHI)
Kojimachi Business Center Building,
5-3-1 Kojimachi, Chiyoda-ku,
Tokyo 102-0083
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Allergy and Clinical Immunology, National Research Institute for Child Health and Development, Tokyo; Dr. Kenji Matsumoto
The University of Western Australia, Faculty of Health and Medical Sciences, Perth Children's Hospital, Telethon Kids Institute, Australia; Professor. Susan Prescott
Perth Children's Hospital, Telethon Kids Institute. Research psychologist with the ORIGINS Project, Australia; Dr. Lisa Gibson
Department of Allergy, Tokyo Metropolitan Children's Medical Center, Tokyo; Dr. Masami Narita
Department of Epidemiology and Preventive Medicine, Graduate School of Medicine, Ehime University, Ehime; Dr. Keiko Tanaka
Name of secondary funder(s)

IRB Contact (For public release)
Organization Departments of Pediatrics Juntendo University, Faculty of Medicine
Address 3-1-3 Hongo, Bunkyo-ku TOKYO, 113-0033, JAPAN
Tel 03-3813-3111
Email mi-shinohara@juntendo.ac.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 順天堂大学医学部 小児科学講座

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 20 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 Preinitiation
Date of protocol fixation
2015 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Preparing the entry HP

Management information
Registered date
2017 Year 06 Month 20 Day
Last modified on
2019 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031889

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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