High Flow Nasal Cannula Use in Infants With Bronchiolitis
Primary Purpose
Bronchiolitis
Status
Terminated
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy
MedKit Finland - Usual oxygen therapy
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis focused on measuring infant, high flow nasal cannulae, oxygen therapy, bronchiolitis
Eligibility Criteria
Inclusion Criteria:
- Admission to pediatric ward due to a presumed viral bronchiolitis
- Need of oxygen therapy (oxygen saturation < 92%)
Exclusion Criteria:
- Pertussis
- Needs intubation or CPAP on admission
- Severe congenital heart defect
- Down's syndrome
Sites / Locations
- Central Hospital Jyväskylä
- Oulu Unversity Hospital
- Seinäjoki Central Hospital
- Tampere University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual oxygen therapy
High flow oxygen therapy
Arm Description
Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min
High flow nasal cannula oxygen therapy with Airvo (TM, Fisher & Paykel Healthcare) device
Outcomes
Primary Outcome Measures
Number of patients with treatment failure
Treatment failure = need for change of respiratory support method
Secondary Outcome Measures
Respiratory rate measured by the study physician/nurse
Oxygen saturation (%)
Time from randomisation to end of oxygen therapy
Time from hospital admission to discharge (hours)
The date and time for admission and discharge will be registered for each participant and time from hospital admission to discharge is then calculated in hours and compared between the study groups.
Number of participants needing admission to intensive care unit (ICU)
The number of participants needing admission to intensive care unit (ICU) will be registered in both treatment groups and that number divided by the total number of participants in the groups (percentages) are then compared between the study groups.
Full Information
NCT ID
NCT02737280
First Posted
February 26, 2016
Last Updated
December 17, 2018
Sponsor
University of Oulu
1. Study Identification
Unique Protocol Identification Number
NCT02737280
Brief Title
High Flow Nasal Cannula Use in Infants With Bronchiolitis
Official Title
High Flow Humified Nasal Cannula Oxygen Therapy in Infants Younger Than 6 Months of Age With Viral Bronchiolitis Compared to Usual Oxygen Therapy : a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
March 2016 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in two pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.
Detailed Description
Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in five pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.
The investigators will recruit 160 infants who require oxygen therapy (oxygen saturation <92%) during hospitalization due to a viral bronchiolitis. The participants are randomized to receive oxygen therapy either with high flow or ordinary nasal cannula.The infants are closely observed by study physicians for clinical parameters. The primary end point is treatment failure (need for change of respiratory support method). Secondary endpoints are respiratory rate (RR) and oxygen saturation (%) at specific measuring points, time from randomisation to end of oxygen therapy and time from randomisation to discharge.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
infant, high flow nasal cannulae, oxygen therapy, bronchiolitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual oxygen therapy
Arm Type
Active Comparator
Arm Description
Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min
Arm Title
High flow oxygen therapy
Arm Type
Experimental
Arm Description
High flow nasal cannula oxygen therapy with Airvo (TM, Fisher & Paykel Healthcare) device
Intervention Type
Device
Intervention Name(s)
Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy
Intervention Description
High flow nasal cannula therapy with Airvo (TM, Fisher & Paykel Healthcare) device
Intervention Type
Device
Intervention Name(s)
MedKit Finland - Usual oxygen therapy
Intervention Description
Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min
Primary Outcome Measure Information:
Title
Number of patients with treatment failure
Description
Treatment failure = need for change of respiratory support method
Time Frame
720 hours
Secondary Outcome Measure Information:
Title
Respiratory rate measured by the study physician/nurse
Time Frame
At 30 min, 60 min, 90 min, 4 hours, 8 hours
Title
Oxygen saturation (%)
Time Frame
At 30 min, 60 min, 90 min, 4 hours, 8 hours
Title
Time from randomisation to end of oxygen therapy
Time Frame
At 30 min, 60 min, 90 min, 4 hours, 8 hours
Title
Time from hospital admission to discharge (hours)
Description
The date and time for admission and discharge will be registered for each participant and time from hospital admission to discharge is then calculated in hours and compared between the study groups.
Time Frame
720 hours
Title
Number of participants needing admission to intensive care unit (ICU)
Description
The number of participants needing admission to intensive care unit (ICU) will be registered in both treatment groups and that number divided by the total number of participants in the groups (percentages) are then compared between the study groups.
Time Frame
720 hours
10. Eligibility
Sex
All
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Admission to pediatric ward due to a presumed viral bronchiolitis
Need of oxygen therapy (oxygen saturation < 92%)
Exclusion Criteria:
Pertussis
Needs intubation or CPAP on admission
Severe congenital heart defect
Down's syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marjo Renko, MD, PhD
Organizational Affiliation
University of Oulu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Hospital Jyväskylä
City
Jyväskylä
Country
Finland
Facility Name
Oulu Unversity Hospital
City
Oulu
Country
Finland
Facility Name
Seinäjoki Central Hospital
City
Seinäjoki
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
High Flow Nasal Cannula Use in Infants With Bronchiolitis
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