Study Stopped
High flow oxygen therapy became available as standard care
High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis
1 other identifier
interventional
28
1 country
1
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".
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2017
CompletedStudy Start
First participant enrolled
June 1, 2017
CompletedFirst Posted
Study publicly available on registry
August 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2018
CompletedJuly 24, 2019
July 1, 2019
1.2 years
May 4, 2017
July 23, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
Effect of high flow humidified oxygen therapy on work of breathing
Respiratory rate (n/min)
during first 5 days post enrollment
Effect of high flow humidified oxygen therapy on work of breathing
Use of accessory muscles of respiration (present /not)
first 5 days post enrollment
Effect of high flow humidified oxygen therapy on blood oxygen saturations
Saturation of oxygen (% saturation) as measured by pulse oximeter
first 5 days post enrollment
Effect of high flow humidified oxygen therapy on heart rate
Pulse (n/min) measured by ECG monitor
first 5 days post enrollment
Secondary Outcomes (2)
Proportion of patients requiring intubation and ventilation
from time of enrollment to end of hospital stay (up to 6 months)
Length of hospital stay
from time of enrollment to end of hospital stay (up to 6 months)
Study Arms (2)
standard therapy group
NO INTERVENTIONstandard treatment of viral bronchiolitis with low flow oxygen.
high flow humidified oxygen group
EXPERIMENTALtreatment of viral bronchiolitis with high flow humidified oxygen therapy.
Interventions
application of high flow humidified oxygen therapy at 2l/kg/min
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chris Hani Baragwanath Academic Hospital
Johannesburg, Gauteng, South Africa
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan M Murphy, FCPaed (SA)
University of the Witwatersrand, Johannesburg
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist Intensivist
Study Record Dates
First Submitted
May 4, 2017
First Posted
August 17, 2017
Study Start
June 1, 2017
Primary Completion
August 31, 2018
Study Completion
August 31, 2018
Last Updated
July 24, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share
No plan to share data wit other researchers