UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014603 |
|---|---|
| Receipt number | R000016991 |
| Scientific Title | A study for bronchial inflammation in wheezy infants with viral infection and development of asthma |
| Date of disclosure of the study information | 2014/07/25 |
| Last modified on | 2015/08/10 13:02:22 |
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Basic information
Public title
A study for bronchial inflammation in wheezy infants with viral infection and development of asthma
Acronym
Bronchial inflammation and viral infection in wheezy infants
Scientific Title
A study for bronchial inflammation in wheezy infants with viral infection and development of asthma
Scientific Title:Acronym
Bronchial inflammation and viral infection in wheezy infants
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate parameters and risk factors for developing recurrent wheeze in children with respiratory viral infection.
Basic objectives2
Others
Basic objectives -Others
To detect and identify viruses in Japanese infants experiencing their first episode of wheeze.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To find predictive parameters and bio-markers in recurrent wheeze
Key secondary outcomes
To identify virus profiles in infants experiencing their first episode of wheeze
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 who are hospitalized for respiratory symptoms experiencing their first episode of wheeze with lower respiratory infection
Key exclusion criteria
Patients who have been diagnosed as asthma or have been treated with any asthma medication before enrollment.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuko Sugai |
Organization
National Hospital Organization Fukuyama Medical Center
Division name
Department of pediatrics
Zip code
Address
4-14-17, Okinogami-cho,Fukuyama, Hiroshima, Japan
TEL
084-922-0001
sugai_kazuko@fukuyama-hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuko Sugai |
Organization
National Hospital Organization Fukuyama Medical Center
Division name
Department of pediatrics
Zip code
Address
4-14-17, Okinogami-cho,Fukuyama, Hiroshima, Japan
TEL
084-922-0001
Homepage URL
sugai_kazuko@fukuyama-hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Fukuyama Medical Center
Institute
Department
Personal name
Funding Source
Organization
non
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
Gunma Prefectural Institute of Public Health and Environmental Sciences
National Hospital Organization Yokohama Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
日本大学（東京都）
獨協医科大学（栃木県）
国立病院機構横浜医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
An elevated MIP-1alfa level in nasopharyngeal aspirates from first-wheezing-episode patients with acute respiratory symptoms caused by viral infections may predict recurrent wheezing.
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
Main results already published
Date of protocol fixation
| 2009 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 30 | Day |
Other
Other related information
detect respiratory viruses in infants who were experienced their first episode of wheeze and analyze bio-markers in their sputum.
Management information
Registered date
| 2014 | Year | 07 | Month | 21 | Day |
Last modified on
| 2015 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016991
