Respiratory DiseaseSWISHNCT04287959
SWISH Trial (Strategies for Weaning Infants on Supportive High Flow)
A study testing High flow nasal cannula support in people with Respiratory Disease and Bronchiolitis, Viral, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
Trial summary
Bronchiolitis is a common type of chest infection that tends to affect babies and young children under a year old. In older children and adults, the same viruses that cause bronchiolitis lead to the 'common cold'. Read more about this study
- Who is it for?
- Ages 4 weeks to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disease, Bronchiolitis, Viral, Infant Morbidity
- What is being tested?
- High flow nasal cannula support
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Oct 2023to 1 Jun 2025
- 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 4 weeks to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Clinical diagnosis of bronchiolitis
- Age >4 weeks and <12 months
- Needs HFNC respiratory support in a ward setting for more than 12 hours
Who cannot join
- Requirement for imminent intubation and ventilation or having received mechanical ventilation during the current hospital admission
- Requirement for imminent CPAP support
- Pre-existing or concomitant, non-viral respiratory infection
- Pre-existing respiratory disease
- Ready to wean high-flow after <12 hours of its initiation
- Weight >10kg
Show all 14Show fewer
- Low level of consciousness
- Apnoeas*
- Cyanotic heart disease
- Basilar skull fracture
- Upper airway obstruction
- Craniofacial malformations
- Infants on home oxygen
- Ex-premature infants (born at <32 weeks gestation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised Control Trial Comparing High Flow Weaning Strategies for Infants With Bronchiolitis: Pilot Study
Bronchiolitis is a common type of chest infection that tends to affect babies and young children under a year old. In older children and adults, the same viruses that cause bronchiolitis lead to the 'common cold'.
The symptoms of bronchiolitis are like a common cold and include a blocked or runny nose, a cough and a mildly raised temperature.
Read more
Bronchiolitis affects the bronchioles which are the smaller breathing tubes in the lungs. They produce more mucus than usual and become swollen, leading to a cough and a runny nose. In more severe cases, the tubes become clogged up with mucus which causes breathing problems.
In some babies, the breathing problems may present as breathing fast, with in-drawing of the muscles around the rib cage, and in rare cases, very young babies with bronchiolitis may stop breathing for brief periods ('apnoea'). The illness usually starts with a mild runny nose or cough, gets worse over three to five days or so, and then slowly gets better, usually lasting about 10 to 14 days in total.
Around 2 in 100 infants with bronchiolitis will need to spend some time in hospital during the course of their illness. This is usually for one of two reasons: they need oxygen treatment to keep their oxygen saturations within acceptable levels or they cannot manage to feed from the breast or a bottle because of a blocked nose or difficulty breathing.
Here at the Children's Hospital for Wales we are using 'High flow' to deliver oxygen. This is a relatively new concept on the general paediatric wards, and more established in a setting such as High Dependency Unit (HDU). However, we have been using it successfully on the wards for the last 3 years.
High flow device delivering a mixture of oxygen and air at high flow to help open the child's airways so that their lungs can add oxygen to their blood. It is given through a set of prongs (short plastic tubes) inserted just inside the nostrils.
Research has shown that the early use of high flow can reduce the chances of the child needing escalation of care to a high dependency unit or paediatric intensive care unit.
The investigators are interested in studying the process of weaning high flow support once the child is over the worst of their illness. This will enable the investigators to use the most effective method of weaning babies from their high flow, and ready for discharge. This has the potential to reduce the number of hours spent in hospital for babies and their parents or guardians.
Read the detailed description
Bronchiolitis is the commonest respiratory infection in infancy leading to hospital admission. 46 per 1000 infants were admitted to hospital with bronchiolitis in England in 2011 and more recent studies suggest this number has remained static. This has a significant cost burden on the NHS. Respiratory support, mainly oxygenation, and keeping infants well hydrated are the mainstay of management in hospital.
Respiratory support has traditionally been the domain of intensive care settings. This has been provided through an escalation of therapy from simple oxygen delivery by nasal cannula, to non-invasive ventilation with Continuous Positive Airway Pressure (CPAP) and finally to intubation with mechanical ventilation. These latter two strategies require highly skilled staff, so are costly, and are associated with a greater incidence of adverse events including ventilator-induced lung injury, barotrauma, and potential neurotoxicity associated with sedation. Over the last decade High Flow Nasal Cannula (HFNC) therapy has emerged as a new method to provide respiratory support for bronchiolitis. HFNC therapy works by delivering an increased volume of air and oxygen into the nasal passages than standard sub-nasal oxygen therapy, using a higher flow of humidified and heated gas. These increased flow rates exceed peak inspiratory flow and thereby result in more efficient delivery of oxygen to the terminal airways. Physiological studies have demonstrated reduced work of breathing and improved gas exchange. The PARIS study has demonstrated that HFNC can be used in a ward setting to reduce admission rates to the Paediatric Intensive Care Unit (PICU). 12% of the study population receiving HFNC needed escalation to PICU compared to 23% receiving standard care (oxygen therapy). The safety data from the PARIS study shows no difference in adverse effects between HFNC and standard oxygen therapy. Numerous studies over the last three decades have investigated the role of various medications in managing infants with bronchiolitis including adrenaline, steroids, salbutamol, and hypertonic saline; none of these studies have definitively changed the outcome of the disease nor the length of stay in hospital. Although the PARIS study showed a reduction in number of patients requiring escalation of care, it did not demonstrate any difference to the total length of stay in hospital.
Aim Since HFNC is a relatively new method of providing respiratory support in bronchiolitis, there is lack of evidence on weaning strategy. The investigators primary aim is to examine the feasibility of different weaning strategies for infants, up to 12 months of age, supported on HFNC for bronchiolitis. The secondary outcomes include the time from decision to wean HFNC to the patient no longer requiring respiratory support and a safety assessment of the weaning strategies. This may lead to shorter total length of stay in hospital, without compromising their care. Infants with bronchiolitis who are on HFNC (the devices used will be Airvo 2, Fisher \& Paykel Healthcare) will be on a flow of 2L/kg/min (maximum 20L/min) and variable oxygen concentration to maintain target oxygen saturations >90%. The participants will be randomised into one of two arms for weaning a) titrating oxygen to FiO2 21% and then stopping HFNC b) titrating oxygen to FiO2 30% and switching HFNC to low flow oxygen.
- Conditions
- Respiratory Disease, Bronchiolitis, Viral, Infant Morbidity
- Being tested
- High flow nasal cannula support
- Medical subject headings
- Respiration Disorders, Bronchiolitis, Viral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannula supportDevice
airvo2 highflow devices will be used.
| Study group | Role | What they receive |
|---|---|---|
| A: wean to 30% | Active comparator | wean to 30% oxygen on high flow and then turn off high flow support and place onto standard low flow oxygen. Receives: Device: High flow nasal cannula support |
| B: wean to 21% | Active comparator | wean to 21% oxygen on high flow and then turn off high flow support and place directly into air. Receives: Device: High flow nasal cannula support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examine the feasibility of different weaning strategies for infants with bronchiolitis requiring HFNC.
we will assess the following objective in this feasibility trial:
- identify the proportion of eligible patients approached who consent to the study; We will use a traffic light system to determine progress to a multi-centre RCT.
Measured: This will be during the recruitment time of the study (2 years)
Identify the proportion of recruited patients who supply secondary outcome data.
We will assess the following objective:
identify the proportion (percentage) of recruited patients who supply primary outcome data(time spent in hospital).
Measured: This will be during the recruitment time of the study (2 years)
Assess the adherence of the teams on the ward to the weaning protocol assigned during randomisation.
We will assess the following objective:
to review the adherence to the weaning protocol assigned during randomisation, in particular if this can be complied with in a ward setting with a large number of healthcare staff. This will be measured as a yes or no response and calculated as a percentage/proportion.
Measured: This will be during the recruitment time of the study (2 years)
Assess the acceptability of HFNC and the weaning strategy by parents and healthcare staff.
We will assess the following objectives:
to assess the acceptability of HFNC and the weaning strategy by parents and healthcare staff via questionnaires only.
Measured: This will be during the recruitment time of the study (2 years)
Secondary outcomes (2)
Time taken to wean off the highflow machine as measured in minutes and hours.
The main secondary outcome is the comparison of time taken from the patient being ready to wean HFNC to discontinuing any respiratory support. This will be measured in minutes and hours and a comparison made between the two intervention arms.
Measured: This will be during the recruitment time of the study (2 years)
To assess the safety of the different weaning strategies used.
The safety outcome measures comprise the following:
- rates of failure to wean strategy (defined as fulfilment of the 'failure to wean criteria' which results in a patient becoming temporarily ineligible for oxygen weaning);
- rates of respiratory escalation requiring CPAP or invasive ventilation (proportions);
- rates of air leaks and other morbidities such as pnuemothorax or muscosal injury (proportions);
- readmission rates within 14 days of discharge from hospital
- mortality rates
Measured: This will be over the 2 years of recruitment time of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start6 Oct 2023
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory DiseaseStudies 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
- Model description
- Given this is a pilot study, a recruitment target has not been set. Instead the study will aim to assess recruitment success which will inform a larger multicentre trial if deemed feasible
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiff and Vale University Health Board
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Martin O Edwards, PhD, BM, Principal investigator, CAVUHB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287959
- Sponsor's protocol ID
- 19/OCT/7769
- Acronym
- SWISH
- Status last verified
- Jun 2025
- First submitted
- 24 Feb 2020
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Towriss C, Dafydd C, Edwards M. High-flow weaning strategies for infants with bronchiolitis: protocol for a pilot randomised controlled trial in the UK. BMJ Open. 2024 Nov 9;14(11):e087672. doi: 10.1136/bmjopen-2024-087672.
PubMed 39521467
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Control Trial Comparing High Flow Weaning Strategies for Infants With Bronchiolitis: Pilot Study
- ClinicalTrials.gov ID
- NCT04287959
- Acronym / sponsor ID
- SWISH / 19/OCT/7769
- Conditions
- Respiratory Disease, Bronchiolitis, Viral, Infant Morbidity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cardiff and Vale University Health BoardOther government
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 27 Feb 2020 (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.
Bronchiolitis is a common type of chest infection that tends to affect babies and young children under a year old. In older children and adults, the same viruses that cause bronchiolitis lead to the 'common cold'.
The symptoms of bronchiolitis are like a common cold and include a blocked or runny nose, a cough and a mildly raised temperature.
Bronchiolitis affects the bronchioles which are the smaller breathing tubes in the lungs. They produce more mucus than usual and become swollen, leading to a cough and a runny nose. In more severe cases, the tubes become clogged up with mucus which causes breathing problems.
In some babies, the breathing problems may present as breathing fast, with in-drawing of the muscles around the rib cage, and in rare cases, very young babies with bronchiolitis may stop breathing for brief periods ('apnoea'). The illness usually starts with a mild runny nose or cough, gets worse over three to five days or so, and then slowly gets better, usually lasting about 10 to 14 days in total.
Around 2 in 100 infants with bronchiolitis will need to spend some time in hospital during the course of their illness. This is usually for one of two reasons: they need oxygen treatment to keep their oxygen saturations within acceptable levels or they cannot manage to feed from the breast or a bottle because of a blocked nose or difficulty breathing.
Here at the Children's Hospital for Wales we are using 'High flow' to deliver oxygen. This is a relatively new concept on the general paediatric wards, and more established in a setting such as High Dependency Unit (HDU). However, we have been using it successfully on the wards for the last 3 years.
High flow device delivering a mixture of oxygen and air at high flow to help open the child's airways so that their lungs can add oxygen to their blood. It is given through a set of prongs (short plastic tubes) inserted just inside the nostrils.
Research has shown that the early use of high flow can reduce the chances of the child needing escalation of care to a high dependency unit or paediatric intensive care unit.
The investigators are interested in studying the process of weaning high flow support once the child is over the worst of their illness. This will enable the investigators to use the most effective method of weaning babies from their high flow, and ready for discharge. This has the potential to reduce the number of hours spent in hospital for babies and their parents or guardians.
Detailed description
Bronchiolitis is the commonest respiratory infection in infancy leading to hospital admission. 46 per 1000 infants were admitted to hospital with bronchiolitis in England in 2011 and more recent studies suggest this number has remained static. This has a significant cost burden on the NHS. Respiratory support, mainly oxygenation, and keeping infants well hydrated are the mainstay of management in hospital.
Respiratory support has traditionally been the domain of intensive care settings. This has been provided through an escalation of therapy from simple oxygen delivery by nasal cannula, to non-invasive ventilation with Continuous Positive Airway Pressure (CPAP) and finally to intubation with mechanical ventilation. These latter two strategies require highly skilled staff, so are costly, and are associated with a greater incidence of adverse events including ventilator-induced lung injury, barotrauma, and potential neurotoxicity associated with sedation. Over the last decade High Flow Nasal Cannula (HFNC) therapy has emerged as a new method to provide respiratory support for bronchiolitis. HFNC therapy works by delivering an increased volume of air and oxygen into the nasal passages than standard sub-nasal oxygen therapy, using a higher flow of humidified and heated gas. These increased flow rates exceed peak inspiratory flow and thereby result in more efficient delivery of oxygen to the terminal airways. Physiological studies have demonstrated reduced work of breathing and improved gas exchange. The PARIS study has demonstrated that HFNC can be used in a ward setting to reduce admission rates to the Paediatric Intensive Care Unit (PICU). 12% of the study population receiving HFNC needed escalation to PICU compared to 23% receiving standard care (oxygen therapy). The safety data from the PARIS study shows no difference in adverse effects between HFNC and standard oxygen therapy. Numerous studies over the last three decades have investigated the role of various medications in managing infants with bronchiolitis including adrenaline, steroids, salbutamol, and hypertonic saline; none of these studies have definitively changed the outcome of the disease nor the length of stay in hospital. Although the PARIS study showed a reduction in number of patients requiring escalation of care, it did not demonstrate any difference to the total length of stay in hospital.
Aim Since HFNC is a relatively new method of providing respiratory support in bronchiolitis, there is lack of evidence on weaning strategy. The investigators primary aim is to examine the feasibility of different weaning strategies for infants, up to 12 months of age, supported on HFNC for bronchiolitis. The secondary outcomes include the time from decision to wean HFNC to the patient no longer requiring respiratory support and a safety assessment of the weaning strategies. This may lead to shorter total length of stay in hospital, without compromising their care. Infants with bronchiolitis who are on HFNC (the devices used will be Airvo 2, Fisher \& Paykel Healthcare) will be on a flow of 2L/kg/min (maximum 20L/min) and variable oxygen concentration to maintain target oxygen saturations >90%. The participants will be randomised into one of two arms for weaning a) titrating oxygen to FiO2 21% and then stopping HFNC b) titrating oxygen to FiO2 30% and switching HFNC to low flow oxygen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Given this is a pilot study, a recruitment target has not been set. Instead the study will aim to assess recruitment success which will inform a larger multicentre trial if deemed feasible
| Arm | Type | Receives |
|---|---|---|
| A: wean to 30% | Active comparator | Device: High flow nasal cannula supportwean to 30% oxygen on high flow and then turn off high flow support and place onto standard low flow oxygen. |
| B: wean to 21% | Active comparator | Device: High flow nasal cannula supportwean to 21% oxygen on high flow and then turn off high flow support and place directly into air. |
Who may qualify
- Ages
- 4 weeks to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Clinical diagnosis of bronchiolitis
- Age >4 weeks and <12 months
- Needs HFNC respiratory support in a ward setting for more than 12 hours
Key exclusion criteria (14 listed)
- Requirement for imminent intubation and ventilation or having received mechanical ventilation during the current hospital admission
- Requirement for imminent CPAP support
- Pre-existing or concomitant, non-viral respiratory infection
- Pre-existing respiratory disease
- Ready to wean high-flow after <12 hours of its initiation
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 nasal cannula supportairvo2 highflow devices will be used. | Device | A: wean to 30%, B: wean to 21% |
Primary outcome
Examine the feasibility of different weaning strategies for infants with bronchiolitis requiring HFNC.
Time frame: This will be during the recruitment time of the study (2 years)
we will assess the following objective in this feasibility trial: • identify the proportion of eligible patients approached who consent to the study; We will use a traffic light system to determine progress to a multi-centre RCT.
Identify the proportion of recruited patients who supply secondary outcome data.
Time frame: This will be during the recruitment time of the study (2 years)
We will assess the following objective: identify the proportion (percentage) of recruited patients who supply primary outcome data(time spent in hospital).
Assess the adherence of the teams on the ward to the weaning protocol assigned during randomisation.
Time frame: This will be during the recruitment time of the study (2 years)
We will assess the following objective: to review the adherence to the weaning protocol assigned during randomisation, in particular if this can be complied with in a ward setting with a large number of healthcare staff. This will be measured as a yes or no response and calculated as a percentage/proportion.
Assess the acceptability of HFNC and the weaning strategy by parents and healthcare staff.
Time frame: This will be during the recruitment time of the study (2 years)
We will assess the following objectives: to assess the acceptability of HFNC and the weaning strategy by parents and healthcare staff via questionnaires only.
2 secondary outcomes
Time taken to wean off the highflow machine as measured in minutes and hours.
Time frame: This will be during the recruitment time of the study (2 years)
To assess the safety of the different weaning strategies used.
Time frame: This will be over the 2 years of recruitment time of the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Derived from this study: PubMed 39521467Towriss C, Dafydd C, Edwards M. High-flow weaning strategies for infants with bronchiolitis: protocol for a pilot randomised controlled trial in the UK. BMJ Open. 2024 Nov 9;14(11):e087672. doi: 10.1136/bmjopen-2024-087672.
- Individual participant dataSharing planned: No
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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.
Martin O Edwards, PhD, BM principal investigator
CAVUHB
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 nasal cannula support in people with Respiratory Disease and Bronchiolitis, Viral, run by Cardiff and Vale University Health Board at 1 site in United Kingdom.
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 3 inclusion and 14 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: finished, as of the sponsor's last update on 8 Jun 2025. 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Examine the feasibility of different weaning strategies for infants with bronchiolitis requiring HFNC. (time frame: This will be during the recruitment time of the study (2 years)). 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?
On the ClinicalTrials.gov record for NCT04287959, which also lists 1 linked publication.
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 8 Jun 2025.