UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044655 |
|---|---|
| Receipt number | 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 13:36:08 |
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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
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
fumi_fena@yahoo.co.jp
Sponsor or person
Institute
Dokkyo Medical University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050723
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
