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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023865
Receipt No. R000027414
Scientific Title The HiRAD study: High-risk cohort for atopic diathesis study
Date of disclosure of the study information 2016/09/01
Last modified on 2018/07/09

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Basic information
Public title The HiRAD study: High-risk cohort for atopic diathesis study
Acronym The HiRAD study
Scientific Title The HiRAD study: High-risk cohort for atopic diathesis study
Scientific Title:Acronym The HiRAD study
Region
Japan

Condition
Condition Eczema
Food Allergy
Asthma
Allergic rhinitis
Classification by specialty
Clinical immunology Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Environmental exposure and medical intervention during early childhood have been thought to have critical effects on the development of atopic march and on the prognosis of allergic diseases. The aims of this prospective study are to elucidate these effects and explore the critical period leading to substantial and/or irreversible effects on the development of allergic diseases.
Basic objectives2 Others
Basic objectives -Others To establish a longitudinal birth cohort study, and conduct a database repository and a long-term storage of biological samples (bio-bank).
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Prevalence at 6, 12, 18 months, and 2, 3, 4, 5, 6 years of age and cumulative incidence of each disease at 6 years of age: atopic dermatitis, food allergy (egg, milk), asthma, allergic rhino-conjunctivitis
[Time frame: 6 years] [Designated as safety issue: No]
Key secondary outcomes Food allergy (wheat, peanut, and others)
Asthma severity
Total IgE, allergen specific IgEs, TARC/CCL17
Allergen specific IgG4s, affinity of OVA-/OVM-specific IgE
Microbiome profiles (skin, gut)
EASI (Eczema Area and Severity Index)
POEM (Patient Oriented Eczema Measure)

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
1 days-old >=
Gender Male and Female
Key inclusion criteria Infants whose guardians consent to this study during mid-pregnancy and who satisfy both of the following criteria:
(1) born at the National Center for Child Health and Development
(2) with a family history of atopic dermatitis (at least any one of parents or siblings)
Key exclusion criteria Non-Japanese-speaking caregivers, stillbirths, any other urgent medical attention necessary
Target sample size 350

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tatsuki Fukuie
Organization National Center for Child Health and Development
Division name Division of General Allergy, Allergy Center
Zip code
Address 2-10-1, Okura, Setagayaku, Tokyo 157-8535, Japan
TEL 03-3416-0181
Email fukuie-t@ncchd.go.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tatsuki Fukuie
Organization National Center for Child Health and Development
Division name Division of General Allergy, Allergy Center
Zip code
Address 2-10-1, Okura, Setagayaku, Tokyo 157-8535, Japan
TEL 03-3416-0611
Homepage URL http://www.ncchd.go.jp/hospital/about/section/seitai-bogyo/allergy.html
Email fukuie-t@ncchd.go.jp

Sponsor
Institute Division of General Allergy, Allergy Center, National Center for Child Health and Development
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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 国立成育医療研究センター アレルギーセンター 総合アレルギー科

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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
2018 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Questionary investigation
Physical examination
Blood examination
TEWL
Microbiome survey (skin / gut)

Management information
Registered date
2016 Year 08 Month 31 Day
Last modified on
2018 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027414

Research Plan
Registered date File name
2018/07/08 ★HiRAD_v1.01_20180709.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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