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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000044655
Receipt No. R000050723
Scientific Title Examination of the relationship between biomarkers in nasal discharge during initial wheezing and the onset of asthma in early childhood
Date of disclosure of the study information 2021/06/26
Last modified on 2021/06/25

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Basic information
Public title Examination of the relationship between biomarkers in nasal discharge during initial wheezing and the onset of asthma in early childhood
Acronym Examination of the relationship between biomarkers in nasal discharge during initial wheezing and the onset of asthma in early childhood
Scientific Title Examination of the relationship between biomarkers in nasal discharge during initial wheezing and the onset of asthma in early childhood
Scientific Title:Acronym Examination of the relationship between biomarkers in nasal discharge during initial wheezing and the onset of asthma in early childhood
Region
Japan

Condition
Condition Bronchial asthma
Classification by specialty
Pneumology Clinical immunology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to clarify biomarkers that predict the onset of recurrent wheezing and asthma using blood and nasal discharge obtained under normal medical care for children who first wheeze in infancy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Differences in nasal discharge biomarkers tested at the time of screening between children in the IgE-related asthma group, non-IgE-related asthma group, and non-asthma group.
Key secondary outcomes

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

Not applicable
Age-upper limit
2 years-old >
Gender Male and Female
Key inclusion criteria Infants under 2 years old who were hospitalized for lower respiratory tract infection and wheezing for the first time after birth
Children who have consented to participate in this study from their substitutes
Key exclusion criteria Preterm infants (less than 37 weeks)
Children who required respiratory management during the newborn period, children with chronic lung disease
Children with a history of autoimmune diseases or metabolic diseases
Children who received treatment by steroids (inhalation, nasal drops, systemic administration) before sample collection (within 24 hours)
Other children who the researcher deems inappropriate for participating in this study
Target sample size 148

Research contact person
Name of lead principal investigator
1st name Fumitaka
Middle name
Last name Takayanagi
Organization Dokkyo Medical University Hospital
Division name Pediatrics
Zip code 321-0293
Address 880 Ozikiitakobayasshi Mibu Shimotsuga Tochigi
TEL 0282-86-1111
Email fumi_fena@yahoo.co.jp

Public contact
Name of contact person
1st name Fumitaka
Middle name
Last name Takayanagi
Organization Dokkyo Medical University Hospital
Division name Pediatrics
Zip code 321-0293
Address 880 Ozikiitakobayasshi Mibu Shimotsuga Tochigi
TEL 0282-86-1111
Homepage URL
Email fumi_fena@yahoo.co.jp

Sponsor
Institute Dokkyo Medical University Hospital
Institute
Department

Funding Source
Organization Dokkyo Medical University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Dokkyo Medical University Hospital
Address 880 Ozikiitakobayasshi Mibu Shimotsuga Tochigi
Tel 0282-86-1111
Email fumi_fena@yahoo.co.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
2021 Year 06 Month 26 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
2021 Year 06 Month 01 Day
Date of IRB
2021 Year 06 Month 01 Day
Anticipated trial start date
2021 Year 06 Month 01 Day
Last follow-up date
2029 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is a multicenter prospective cohort study.
We enroll all patients who visited our hospital between approval by the Clinical Research Ethics Committee in 2021 and March 2023 who met the selection criteria.
We take a nasal discharge sample at admission and measure biomarkers.
After that, a questionnaire survey will be conducted every year for 5 years to evaluate the onset of asthma.
In addition, after 2 years and 5 years, asthma phenotypes will be classified according to the presence or absence of an increase in IgE, and it will be examined whether biomarkers differ for each phenotype.

Management information
Registered date
2021 Year 06 Month 25 Day
Last modified on
2021 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050723

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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