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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025243
Receipt No. 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

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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
Email 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
Email mari.saito@haga.jrc.or.jp

Sponsor
Institute Haga Red Cross Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029038

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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