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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017792
Receipt No. R000015392
Scientific Title Heliox inhalation therapy for Japanese pediatrics with respiratory distress and/or respiratory failure associated with acute bronchiolitis - historical control open study
Date of disclosure of the study information 2015/06/03
Last modified on 2015/06/03

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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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