UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025065
Receipt number R000028837
Scientific Title 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
Date of disclosure of the study information 2016/12/01
Last modified on 2017/02/08 00:59:35

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Basic information

Public title

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

Acronym

Helium-Oxygen gas clinical trial for infant with obstructive airway disease

Scientific Title

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

Scientific Title:Acronym

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

1st name
Middle name
Last name Naoki Shimizu

Organization

Tokyo Metropolitan Children's Medical Center

Division name

Department of Crtical Care Medicine

Zip code


Address

2-8-29, Musashidai, Fuchu city, Tokyo, Japan

TEL

042-300-5111

Email

naoki_shimizu@me.com


Public contact

Name of contact person

1st name
Middle name
Last name Kenji Morimoto

Organization

Tokyo Metropolitan Children's Medical Center

Division name

Department of Crtical Care Medicine

Zip code


Address

2-8-29, Musashidai, Fuchu city, Tokyo, Japan

TEL

042-300-5111

Homepage URL


Email

kjas09100728@gmail.com


Sponsor or person

Institute

Tokyo Metropolitan Children's Medical Center

Institute

Department

Personal name



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)



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

2016 Year 12 Month 01 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

Open public recruiting

Date of protocol fixation

2016 Year 11 Month 13 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028837


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name