UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Establishment of the algorithm for reccurent infant wheezing under 2 years of age
Title of the study (Brief title)	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	Mari Saito
Organization	Haga Red Cross Hospital
Division name	Pediatrics
Address	2461 Daimachi, Mouka, Tochigi, Japan
TEL	0285-52-2195
Email	mari.saito@haga.jrc.or.jp

Public contact
Name of contact person	Mari Saito
Organization	Haga Red Cross Hospital
Division name	Pediatrics
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029038