UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020531 |
|---|---|
| Receipt number | 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 20:06:02 |
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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
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
kazgoto@be.mbn.or.jp
Sponsor or person
Institute
Sugai children's clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021550
