UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025243 |
|---|---|
| Receipt number | R000029038 |
| Scientific Title | Establishment of the algorithm for reccurent infant wheezing under 2 years of age |
| Date of disclosure of the study information | 2017/01/04 |
| Last modified on | 2018/12/17 08:47:01 |
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Basic information
Public title
Establishment of the algorithm for reccurent infant wheezing under 2 years of age
Acronym
The algorithm for infant wheeze
Scientific Title
Establishment of the algorithm for reccurent infant wheezing under 2 years of age
Scientific Title:Acronym
The algorithm for infant wheeze
Region
| Japan |
Condition
Condition
Infant wheeze
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the algorithms to distinguish between multiple diseases that cause infant wheezing with safely and efficiently
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Percentage of identified underlying diseases that cuase infant wheeze
Key secondary outcomes
How infant wheeze improves by intervening in the idenfitied underlying disease at 1-year follow up.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
8
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Suspected infatn asthma.
Administer a systemic steroid therapy.
Prednisolone 1.5mg/kg/day, 3x iv.
Interventions/Control_2
Lower respiratory infection.
Administer physical therapy and/or antibiotic treatment.
CTX 100mg/kg/day, 3x iv.
Interventions/Control_3
Suspected airway ciliary movement abnormality.
Administer low-dose macrolide therapy.
Clarithromycin 5mg/kg/day, 1x po.
Interventions/Control_4
Suspected gastroesophageal reflux disease.
Administer H2-blocker therapy.
Famotidine 1mg/kg/day, 2x po.
Interventions/Control_5
Suspected of congenital immunodeficiency.
Administer immunoglobulin replacement therapy and/or low-dose macrolide therapy as necessary.
Immunoglobulin 300mg/kg for 1st time, 200mg/kg for the second and subsequent times.
Interventions/Control_6
Congenital heart disease.
Operate surgical treatment and/or administer medication for heart failure as necessary.
Interventions/Control_7
Bronchial morphology abnormality.
Operate surgical treatment and/or administer medication as necessary.
Interventions/Control_8
Mixed diseases with above underlying diseases and infant asthma.
In addition to the treatment described above, administer a systemic steroid therapy.
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 2 | months-old | <= |
Age-upper limit
| 24 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
Infant admitted to our hospital with lower respiratory tract inflammation (pneumonia, bronchitis, bronchiolitis)
Key exclusion criteria
Infants who have already been diagnosed with respiratory disease such as cerebral palsy, diaphragmatic hernia, chronic lung disease
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mari Saito |
Organization
Haga Red Cross Hospital
Division name
Pediatrics
Zip code
Address
2461 Daimachi, Mouka, Tochigi, Japan
TEL
0285-52-2195
mari.saito@haga.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mari Saito |
Organization
Haga Red Cross Hospital
Division name
Pediatrics
Zip code
Address
2461 Daimachi, Mouka, Tochigi, Japan
TEL
0285-52-2195
Homepage URL
mari.saito@haga.jrc.or.jp
Sponsor or person
Institute
Haga Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 04 | 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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 17 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 17 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 17 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 13 | Day |
Last modified on
| 2018 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029038
