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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000020531
Receipt No. R000021550
Scientific Title A cohort study for asthma predictive marker in Japanese infants with their first wheeze
Date of disclosure of the study information 2016/01/12
Last modified on 2019/07/16

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Basic information
Public title A cohort study for asthma predictive marker in Japanese infants with their first wheeze
Acronym Predictive markers at the first time of wheezes for asthma developmemt in Japanese infants
Scientific Title A cohort study for asthma predictive marker in Japanese infants with their first wheeze
Scientific Title:Acronym Predictive markers at the first time of wheezes for asthma developmemt in Japanese infants
Region
Japan

Condition
Condition acute bronchitis
Classification by specialty
Clinical immunology Pediatrics Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe biomarkers prospectivey in patients' nasal discharge at their first time of wheeze.To validate our prior research and to seek a cut off level for MIP1-alfa.
Basic objectives2 Others
Basic objectives -Others To investigate sensitization for allergens in children with recurrent wheeze.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Clinical usefulness and cut off level of MIP1-alfa in first wheeze infants.
Key secondary outcomes Sensitization for allergens and food allergy in infants with recurrent wheeze and development of asthma.

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 months-old <=
Age-upper limit
24 months-old >
Gender Male and Female
Key inclusion criteria Infants who have the first wheezing episodes with viral lower respiratory infection.
Key exclusion criteria 1 Patients who have been diagnosed as asthma or habe been had wheezing episodes before enrollment.

2. Preterm infants
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Kazuko
Middle name
Last name Sugai
Organization Sugai children's clinic
Division name Department of Pediatrics
Zip code 7300044
Address 2-1Takara-machi, Naka-ku,Hiroshima city,Hiroshima
TEL +81822073888
Email kazgoto@be.mbn.or.jp

Public contact
Name of contact person
1st name Kazuko
Middle name
Last name Kazuko Sugai
Organization Sugai Children's clinic
Division name Department of Pediatrics
Zip code 7300044
Address 2-1 Takaramachi, Naka-ku,Hiroshima-city
TEL +81822073888
Homepage URL
Email kazgoto@be.mbn.or.jp

Sponsor
Institute Sugai children's clinic
Institute
Department

Funding Source
Organization Sugai children's clinic
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Nihon University
Dokkyo Medical University
National Institute of Infectious Diseases
Name of secondary funder(s)

IRB Contact (For public release)
Organization National hospital organization fukuyama medical center
Address 4-14-17, Okinogami-cho, Fukuyama, Hiroshima,720-8520 Japan
Tel +81849220001
Email rinnshou@fukuyama-hosp.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 国立病院機構福山医療センター(広島県)
日本大学(東京都)
獨協医科大学(栃木県)

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 12 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 Terminated
Date of protocol fixation
2015 Year 07 Month 22 Day
Date of IRB
2015 Year 07 Month 22 Day
Anticipated trial start date
2015 Year 07 Month 22 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2022 Year 12 Month 31 Day
Date analysis concluded
2023 Year 12 Month 31 Day

Other
Other related information Analyze biomarkers of nasopharyngeal discharses from infants who have their first wheezing episodes.

Management information
Registered date
2016 Year 01 Month 12 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021550

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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