Back to resultsHigh Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis
Primary Purpose
Bronchiolitis, Viral
Status
Terminated
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
High flow humidified oxygen therapy
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiolitis, Viral
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of viral bronchiolitis
- Not requiring intubation and ventilation
- Admitted to high care unit
- With moderate/severe respiratory distress (Tal score >6)
- Saturations <92% in room air
Exclusion Criteria:
- congenital cardiac disease
- presence of multiorgan failure/multisystemic disease
- previously ventilated
- craniofacial abnormalities
- nasal pathology
- decreased level of consciousness
- Ex-prem <34 weeks
- Possible impending respiratory failure
Sites / Locations
- Chris Hani Baragwanath Academic Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
standard therapy group
high flow humidified oxygen group
Arm Description
standard treatment of viral bronchiolitis with low flow oxygen.
treatment of viral bronchiolitis with high flow humidified oxygen therapy.
Outcomes
Primary Outcome Measures
Effect of high flow humidified oxygen therapy on work of breathing
Respiratory rate (n/min)
Effect of high flow humidified oxygen therapy on work of breathing
Use of accessory muscles of respiration (present /not)
Effect of high flow humidified oxygen therapy on blood oxygen saturations
Saturation of oxygen (% saturation) as measured by pulse oximeter
Effect of high flow humidified oxygen therapy on heart rate
Pulse (n/min) measured by ECG monitor
Secondary Outcome Measures
Proportion of patients requiring intubation and ventilation
number of patients (N) getting intubated
Length of hospital stay
days (N) spent in hospital
Full Information
NCT ID
NCT03252119
First Posted
May 4, 2017
Last Updated
July 23, 2019
Sponsor
Chris Hani Baragwanath Academic Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03252119
Brief Title
High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis
Official Title
High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Terminated
Why Stopped
High flow oxygen therapy became available as standard care
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chris Hani Baragwanath Academic Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A randomized control trial of 130 infants admitted to the paediatric high care admission ward will be enrolled, and randomized to either "high flow humidified oxygen" or "standard therapy".
Detailed Description
A randomized control trial of 130 infants admitted to the paediatric high care admission ward will be enrolled. Infants between 1 month and 2 years of age who fulfill criteria for enrollment shall be considered eligible. Informed consent from parents or legal guardians shall be obtained. Infants shall be randomized to either "standard therapy" or "high flow humidified oxygen". Measurements of heart rate, respiratory rate, work of breathing (Tal score and WCAS), oxygen saturation and oxygen requirements shall be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis, Viral
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard therapy group
Arm Type
No Intervention
Arm Description
standard treatment of viral bronchiolitis with low flow oxygen.
Arm Title
high flow humidified oxygen group
Arm Type
Experimental
Arm Description
treatment of viral bronchiolitis with high flow humidified oxygen therapy.
Intervention Type
Device
Intervention Name(s)
High flow humidified oxygen therapy
Intervention Description
application of high flow humidified oxygen therapy at 2l/kg/min
Primary Outcome Measure Information:
Title
Effect of high flow humidified oxygen therapy on work of breathing
Description
Respiratory rate (n/min)
Time Frame
during first 5 days post enrollment
Title
Effect of high flow humidified oxygen therapy on work of breathing
Description
Use of accessory muscles of respiration (present /not)
Time Frame
first 5 days post enrollment
Title
Effect of high flow humidified oxygen therapy on blood oxygen saturations
Description
Saturation of oxygen (% saturation) as measured by pulse oximeter
Time Frame
first 5 days post enrollment
Title
Effect of high flow humidified oxygen therapy on heart rate
Description
Pulse (n/min) measured by ECG monitor
Time Frame
first 5 days post enrollment
Secondary Outcome Measure Information:
Title
Proportion of patients requiring intubation and ventilation
Description
number of patients (N) getting intubated
Time Frame
from time of enrollment to end of hospital stay (up to 6 months)
Title
Length of hospital stay
Description
days (N) spent in hospital
Time Frame
from time of enrollment to end of hospital stay (up to 6 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of viral bronchiolitis
Not requiring intubation and ventilation
Admitted to high care unit
With moderate/severe respiratory distress (Tal score >6)
Saturations <92% in room air
Exclusion Criteria:
congenital cardiac disease
presence of multiorgan failure/multisystemic disease
previously ventilated
craniofacial abnormalities
nasal pathology
decreased level of consciousness
Ex-prem <34 weeks
Possible impending respiratory failure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan M Murphy, FCPaed (SA)
Organizational Affiliation
University of the Witwatersrand, Johannesburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chris Hani Baragwanath Academic Hospital
City
Johannesburg
State/Province
Gauteng
Country
South Africa
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data wit other researchers
Learn more about this trial
High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis
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