UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023865 |
|---|---|
| Receipt number | 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 | 2020/09/03 12:01:16 |
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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
Name of lead principal investigator
| 1st name | Tatsuki |
| Middle name | |
| Last name | Fukuie |
Organization
National Center for Child Health and Development
Division name
Division of General Allergy, Allergy Center
Zip code
157-8535
Address
2-10-1, Okura, Setagayaku, Tokyo 157-8535, Japan
TEL
03-3416-0181
fukuie-t@ncchd.go.jp
Public contact
Name of contact person
| 1st name | Tatsuki |
| Middle name | |
| Last name | Fukuie |
Organization
National Center for Child Health and Development
Division name
Division of General Allergy, Allergy Center
Zip code
157-8535
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
fukuie-t@ncchd.go.jp
Sponsor or person
Institute
Division of General Allergy, Allergy Center, National Center for Child Health and Development
Institute
Department
Personal name
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
National Center for Child Health and Development
Address
2-10-1, Okura, Setagayaku, Tokyo 157-8535, Japan
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
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
| 2020 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.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 |
