UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II clinical trial for the effectiveness and safety of AW-PD01 (helium / oxygen mixed gas) for respiratory failure in children and infants with airway stenotic lesions: Single facility single group open label intervention study
Title of the study (Brief title)	Helium-Oxygen gas clinical trial for infant with obstructive airway disease
Region	Japan

Condition
Condition	Respiratory failure, Bronchiolitis
Classification by specialty	Pediatrics Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparing the effectiveness and safety for respiratory failure in Japanese children / infants with obstructive airway disease between AW-PD01 (helium/oxygen mixed gas) therapy and existing therapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Airway resistance
Key secondary outcomes	PaCO2, tidal volume, lung compliance, the product of PaCO2 and driving pressure, length of ICU stay, length of intubation, safety

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Heliox
Interventions/Control_2	Air
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	0 years-old <=
Age-upper limit	2 years-old >
Gender	Male and Female
Key inclusion criteria	1. Patients who are diagnosed with acute bronchiolitis due to clinical symptoms (tachypnea, cough, extension of expiration time, exhalation wheezing, rale sounds and increasing work of breathing ), chest X-ray (pulmonary hyperinflation) 2. Hospitalized patients in intensive care unit 3. Patients who receive mechanical ventilation 4. written informed consent is obtained from the parent
Key exclusion criteria	1. With cyanotic heart disease 2. With chronic lung disease 3. Receiving a diagnosis of bronchial asthma 4. patients who are judged unsuitable as subjects of the examination by the attending doctor
Target sample size	10

Research contact person
Name of lead principal investigator	Naoki Shimizu
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Department of Crtical Care Medicine
Address	2-8-29, Musashidai, Fuchu city, Tokyo, Japan
TEL	042-300-5111
Email	naoki_shimizu@me.com

Public contact
Name of contact person	Kenji Morimoto
Organization	Tokyo Metropolitan Children's Medical Center
Division name	Department of Crtical Care Medicine
Address	2-8-29, Musashidai, Fuchu city, Tokyo, Japan
TEL	042-300-5111
Homepage URL
Email	kjas09100728@gmail.com

Sponsor
Institute	Tokyo Metropolitan Children's Medical Center
Institute
Department

Funding Source
Organization	Center for Clinical Trials, Japan Medical Association
Organization
Division
Category of Funding Organization	Non profit foundation
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	2016 Year 12 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 13 Day
Anticipated trial start date	2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 30 Day
Last modified on	2017 Year 02 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028837