UMIN-CTR Clinical Trial

Basic information
Public title	Heliox inhalation therapy for Japanese pediatrics with respiratory distress and/or respiratory failure associated with acute bronchiolitis - historical control open study
Acronym	Heliox inhalation therapy for pediatric severe acute bronchiolitis
Scientific Title	Heliox inhalation therapy for Japanese pediatrics with respiratory distress and/or respiratory failure associated with acute bronchiolitis - historical control open study
Scientific Title:Acronym	Heliox inhalation therapy for pediatric severe acute bronchiolitis
Region	Japan Asia(except Japan)

Condition
Condition	acute bronchiolitis
Classification by specialty	Pneumology Pediatrics Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate Heliox can shorten the PICU stay of Japanese pediatric patients with respiratory distress and/or respiratory failure associated with acute bronchiolitis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	To compare Length of PICU stay in Heliox group with historical control group. The criteria of PICU discharge is; SpO2 is more than 92% and clinically stable more than 6 hours under CPAP less than 10cmH2O and FIO2 less than 0.4.
Key secondary outcomes	To compare Heliox group with historical control group. 1. Ventilation priod, CPAP priod, length of oxygen therapy, length of hospital stay, incidence rate of VAP, status of antibiotic usage. 2. To compare SpO2, EtCO2, PaO2, PaCO2, and tcPCO2 before Heliox administration with 15 minutes or 1 hour after Heliox administration .

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Other
Interventions/Control_1	To administer Heliox by a ventilator and/or a CPAP device. To continue to wean from ventilator and/or CPAP, or within 7 days whichever shorter.
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	1. Less than 2 years old at the time of PICU admission. 2. On ventilator or CPAP. 3. the patients who are diagnosed to acute bronchiolitis Clinically (tachypnea, coughing, prolongation of expiratory time, expiratory stridor, moist rale and retraction), chest x-ray(with or without lung hyperinflation) and M-WCAS (more that 5). 4. Get informed consent from legal representative.
Key exclusion criteria	1. Patients who have severe congenital heart diseases. 2. Patients who has severe chronic lung disease. 3. Patients who have severe malformation of bronchi or lung. 4. Patients who are diagnosed as bronchial asthma and under treatment. 5. Patients who have severe physiologic conditions continued more than 6 hours as follows. 1) OI>15cmH2O/mmHg 2) Mean arterial pressure<30mmHg 3) Heart rate>200bpm 6. Patients who have to use medical devices with hot wire flow sensor (exclude the device which is confirmed with Heliox). 7. Patients who are predicted that need Heliox inhalation more than 7 days. 8. Other patients who are identified as inappropriate for this study by the physicians in charge.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Middle name Last name Seiki Abe
Organization	Nagano Children's Hospital
Division name	anesthesiology
Zip code
Address	3100 Toyoshina, Azumino city, Nagano, Japan
TEL	0263-73-6700
Email	seiki0623@yahoo.co.jp

Public contact
Name of contact person	1st name Middle name Last name Seiki Abe
Organization	Nagano Children's Hospital
Division name	anesthesiology
Zip code
Address	3100 Toyoshina, Azumino city, Nagano, Japan
TEL	0263-73-6700
Homepage URL
Email	seiki0623@yahoo.co.jp

Sponsor
Institute	Nagano Children's Hospital Division of anesthesiology
Institute
Department

Funding Source
Organization	AIR WATER R&D CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Tokyo Metropolitan Children's medical center Department of Pediatric Emergency & Critical Care Medicine
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	長野県立こども病院（長野県）、東京都立小児総合医療センター（東京都）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 03 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	2012 Year 09 Month 24 Day
Date of IRB
Anticipated trial start date	2012 Year 11 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 06 Month 03 Day
Last modified on	2015 Year 06 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015392

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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