Bronchiolitis, ViralNCT03252119
High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis
A study testing High flow humidified oxygen therapy in people with Bronchiolitis, Viral, run by Chris Hani Baragwanath Academic Hospital at 1 site in South Africa.
Trial 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". Read more about this study
- Who is it for?
- Ages 1 month to 2 years
- Conditions the study is for
- Bronchiolitis, Viral
- What is being tested?
- High flow humidified oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Jun 2017to 31 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Chris Hani Baragwanath Academic Hospital
Johannesburg, Gauteng
About this study
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".
Read the 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.
- Conditions
- Bronchiolitis, Viral
- Being tested
- High flow humidified oxygen therapy
- Medical subject headings
- Bronchiolitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow humidified oxygen therapyDevice
application of high flow humidified oxygen therapy at 2l/kg/min
| Study group | Role | What they receive |
|---|---|---|
| standard therapy group | No intervention | standard treatment of viral bronchiolitis with low flow oxygen. |
| high flow humidified oxygen group | Experimental | treatment of viral bronchiolitis with high flow humidified oxygen therapy. Receives: Device: High flow humidified oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of high flow humidified oxygen therapy on work of breathing
Respiratory rate (n/min)
Measured: 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)
Measured: 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
Measured: first 5 days post enrollment
Effect of high flow humidified oxygen therapy on heart rate
Pulse (n/min) measured by ECG monitor
Measured: first 5 days post enrollment
Secondary outcomes (2)
Proportion of patients requiring intubation and ventilation
number of patients (N) getting intubated
Measured: from time of enrollment to end of hospital stay (up to 6 months)
Length of hospital stay
days (N) spent in hospital
Measured: from time of enrollment to end of hospital stay (up to 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study start1 Jun 2017
- Primary completion31 Aug 2018
- Study completion31 Aug 2018
Why it stopped: High flow oxygen therapy became available as standard care
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis, ViralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chris Hani Baragwanath Academic Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Murphy, Chris Hani Baragwanath Academic Hospital
- Investigators
- Susan M Murphy, FCPaed (SA), Principal investigator, University of the Witwatersrand, Johannesburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03252119
- Sponsor's protocol ID
- M170234
- Status last verified
- Jul 2019
- First submitted
- 4 May 2017
- Last updated
- 24 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share data wit other researchers
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Oxygen Therapy vs Standard Care in Infants With Viral Bronchiolitis
- ClinicalTrials.gov ID
- NCT03252119
- Acronym / sponsor ID
- M170234
- Conditions
- Bronchiolitis, Viral
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: High flow oxygen therapy became available as standard care
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Chris Hani Baragwanath Academic HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 17 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard therapy group | No intervention | –standard treatment of viral bronchiolitis with low flow oxygen. |
| high flow humidified oxygen group | Experimental | Device: High flow humidified oxygen therapytreatment of viral bronchiolitis with high flow humidified oxygen therapy. |
Who may qualify
- Ages
- 1 month to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- congenital cardiac disease
- presence of multiorgan failure/multisystemic disease
- previously ventilated
- craniofacial abnormalities
- nasal pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High flow humidified oxygen therapyapplication of high flow humidified oxygen therapy at 2l/kg/min | Device | high flow humidified oxygen group |
Primary outcome
Effect of high flow humidified oxygen therapy on work of breathing
Time frame: during first 5 days post enrollment
Respiratory rate (n/min)
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)
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
Effect of high flow humidified oxygen therapy on heart rate
Time frame: first 5 days post enrollment
Pulse (n/min) measured by ECG monitor
2 secondary outcomes
Proportion of patients requiring intubation and ventilation
Time frame: 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)
Results and safety
The study was stopped early (reason given: High flow oxygen therapy became available as standard care). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2019.
- Individual participant dataSharing planned: No. No plan to share data wit other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan M Murphy, FCPaed (SA) principal investigator
University of the Witwatersrand, Johannesburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flow humidified oxygen therapy in people with Bronchiolitis, Viral, run by Chris Hani Baragwanath Academic Hospital at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: High flow oxygen therapy became available as standard care). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of high flow humidified oxygen therapy on work of breathing (time frame: during first 5 days post enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.