UMIN-CTR Clinical Trial

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

acute bronchiolitis

Classification by specialty

Pneumology	Pediatrics	Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

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

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 .

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nagano Children's Hospital
Division of anesthesiology

Institute

Department

Personal name

Organization

AIR WATER R&D CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Tokyo Metropolitan Children's medical center
Department of Pediatric Emergency & Critical Care Medicine

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2015

Year

06

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2015

Year

06

Month

03

Day

Last modified on

2015

Year

06

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015392