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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000018560
Receipt No. R000021478
Scientific Title Comparison of infantile allergic disease prevalence by 12 year interval cohort studies
Date of disclosure of the study information 2016/08/06
Last modified on 2018/10/10

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Basic information
Public title Comparison of infantile allergic disease prevalence by 12 year interval cohort studies
Acronym Sagamihara infant cohort study
(Sagamihara cohort)
Scientific Title Comparison of infantile allergic disease prevalence by 12 year interval cohort studies
Scientific Title:Acronym Sagamihara infant cohort study
(Sagamihara cohort)
Region
Japan

Condition
Condition food allergy
atopic dermatitis
bronchial asthma
allergic rhinitis
Classification by specialty
Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We had followed up a birth cohort in Sagamihara-City to clarify profiles of allergic diseases during the first 7 years of life from 2002. We began to follow the same cohort again from 2014 with a 12 year interval. The purpose of the current survey is to clarify changes in prevalence of infantile allergic diseases and environmental factors, compared with data from 2002.
Basic objectives2 Others
Basic objectives -Others Prevalence of infantile allergic diseases at 4 months, 8 months, 1 year, 3 years, 5 years, 7 years.
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Prevalence of infantile allergic diseases at 4 months, 8 months, 1 year, 3 years, 5 years, 7 years.
Key secondary outcomes Association of prevalence of infantile allergic diseases with following factors.
# Method of feeding
# Indirect cigarette exposure
# Environmental antigen exposure
# Family history of allergic disease
# Birth order

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
4 months-old <=
Age-upper limit
84 months-old >=
Gender Male and Female
Key inclusion criteria Subjects who received the mass medical examination at the age of 4 months, and whose parents agreed to participate in the study
Key exclusion criteria None
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motohiro Ebisawa
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address 18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Email mebisawa@foodallergy.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chizuko Sugizaki
Organization National Hospital Organization Sagamihara National Hospital
Division name Department of Allergy, Clinical Research Center for Allergy and Rheumatology
Zip code
Address 18-1, Sakuradai, Minamiku, Sagamihara City, Kanagawa, Japan, 252-0392
TEL 042-742-8311
Homepage URL
Email sugizaki@foodallergy.jp

Sponsor
Institute National Hospital Organization Sagamihara National Hospital
Institute
Department

Funding Source
Organization Research grant by the Ministry of Health, Labour and Welfare of Japan
The Japan Agency for Medical Research and Development (AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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 国立病院機構相模原病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 06 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 No longer recruiting
Date of protocol fixation
2013 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 01 Month 01 Day
Last follow-up date
2021 Year 08 Month 31 Day
Date of closure to data entry
2021 Year 10 Month 31 Day
Date trial data considered complete
2021 Year 12 Month 31 Day
Date analysis concluded
2022 Year 04 Month 30 Day

Other
Other related information Using the mass medical examination system at the age of 4 months, we obtained basic profile information on subjects from Jan 1st, 2014 to Dec 31st, 2014. We also follow up the subjects whose parents agreed to participate in this study at the ages of 8 months, 1/3/5/7 years.

Management information
Registered date
2015 Year 08 Month 06 Day
Last modified on
2018 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021478

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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