- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03252119
High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis
July 23, 2019 updated by: Susan Murphy, Chris Hani Baragwanath Academic Hospital
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".
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gauteng
-
Johannesburg, Gauteng, South Africa
- Chris Hani Baragwanath Academic hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 2 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: standard therapy group
standard treatment of viral bronchiolitis with low flow oxygen.
|
|
EXPERIMENTAL: high flow humidified oxygen group
treatment of viral bronchiolitis with high flow humidified oxygen therapy.
|
application of high flow humidified oxygen therapy at 2l/kg/min
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effect of high flow humidified oxygen therapy on work of breathing
Time Frame: during first 5 days post enrollment
|
Respiratory rate (n/min)
|
during first 5 days post enrollment
|
Effect of high flow humidified oxygen therapy on work of breathing
Time Frame: first 5 days post enrollment
|
Use of accessory muscles of respiration (present /not)
|
first 5 days post enrollment
|
Effect of high flow humidified oxygen therapy on blood oxygen saturations
Time Frame: first 5 days post enrollment
|
Saturation of oxygen (% saturation) as measured by pulse oximeter
|
first 5 days post enrollment
|
Effect of high flow humidified oxygen therapy on heart rate
Time Frame: first 5 days post enrollment
|
Pulse (n/min) measured by ECG monitor
|
first 5 days post enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients requiring intubation and ventilation
Time Frame: from time of enrollment to end of hospital stay (up to 6 months)
|
number of patients (N) getting intubated
|
from time of enrollment to end of hospital stay (up to 6 months)
|
Length of hospital stay
Time Frame: from time of enrollment to end of hospital stay (up to 6 months)
|
days (N) spent in hospital
|
from time of enrollment to end of hospital stay (up to 6 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Susan M Murphy, FCPaed (SA), University of the Witwatersrand, Johannesburg
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2017
Primary Completion (ACTUAL)
August 31, 2018
Study Completion (ACTUAL)
August 31, 2018
Study Registration Dates
First Submitted
May 4, 2017
First Submitted That Met QC Criteria
August 14, 2017
First Posted (ACTUAL)
August 17, 2017
Study Record Updates
Last Update Posted (ACTUAL)
July 24, 2019
Last Update Submitted That Met QC Criteria
July 23, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- M170234
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
No plan to share data wit other researchers
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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