Acute BronchiolitisNCT06321133
High Flow Nasal Cannula Weaning in Acute Bronchiolitis
A study testing High flow nasal cannula immediate ending and High flow nasal cannula weaning in people with Acute Bronchiolitis, run by Kuopio University Hospital at 4 sites in Finland.
Trial summary
The goal of this clinical study is to compared two different strategies to end high flow nasal cannula treatment in acute bronchiolitis. This study compared the immediate ending of high flow treatment to weaning strategy, in which the flow rate is gradually decreased. Read more about this study
- Who is it for?
- Ages 0 to 12 months
- Conditions the study is for
- Acute Bronchiolitis
- What is being tested?
- High flow nasal cannula immediate ending and High flow nasal cannula weaning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesFinland
- Study dates
- 13 Feb 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinically diagnosed acute bronchiolitis
- High flow nasal cannula treatment has lasted for at least 12 hours
- Measured saturation 95 or more with room air
- High flow rate is maximum 2l/kg/min
- The treating doctors considers the infant suitable to be without high flow
Who cannot join
- Major congenital anomaly of lungs, hearts or diaphragm
- Bacterial pneumonia
- Parents do not give consent
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Finland4 sites, 4 recruiting
- Recruiting
Siun Sote
Joensuu
Paula Widgren, MD, PhD, 0045813 330 8285, paula.widgren@siunsote.fi
- Recruiting
Central Finland Hospital District
Jyväskylä
Milla Pitkänen, MD, 0035814 2691811, milla.pitkanen@hyvaks.fi
- Recruiting
Kuopio University Hospital
Kuopio
Ilari Kuitunen, MD, PhD, +358447174910, ilari.kuitunen@uef.fi
Marjo Renko, Professor
- Recruiting
Mikkeli Central Hospital
Mikkeli
Nicole Weisshoff, MD, 0035815 3511, nicole.weisshoff@etelasavonha.fi
About this study
Official title: High Flow Nasal Cannula Weaning in Acute Bronchiolitis - an Open-label Randomized Controlled Trials
The goal of this clinical study is to compared two different strategies to end high flow nasal cannula treatment in acute bronchiolitis. This study compared the immediate ending of high flow treatment to weaning strategy, in which the flow rate is gradually decreased. The aim is to assess if the immediate ending shortens the hospitalization time and whether it is a safe strategy.
Read the detailed description
Acute bronchiolitis is the most common cause of hospitalization among infants in Finland, with its primary etiology being the RS- virus. Acute bronchiolitis is defined in Finland as an infant's first respiratory distress before the age of 1. There is no effective pharmacological treatment for acute bronchiolitis. High-flow nasal cannula therapy has been shown in large randomized trials to reduce the risk of intensive care unit admission for children. High-flow nasal cannulas are typically used at a flow rate of 2 liters per kilogram per minute. Despite widespread use, there is insufficient evidence to determine whether high-flow therapy should be discontinued abruptly or gradually tapered. Observational studies indicate that the majority of units opt for abrupt discontinuation. Common criteria for discontinuation include weaning off supplemental oxygen and maintaining normal oxygenation on room air for 4-6 hours. Gradual weaning has been shown in observational studies to prolong hospitalization compared to immediate cessation of therapy. In a randomized controlled trial conducted in a pediatric intensive care unit, direct discontinuation shortened the duration of treatment by up to two days. However, there have been no previous randomized trials conducted on bronchiolitis patients.
- Conditions
- Acute Bronchiolitis
- Being tested
- High flow nasal cannula immediate ending, High flow nasal cannula weaning
- Keywords
- Acute bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flow nasal cannula immediate endingOther
High flow is immediately ended
High flow nasal cannula weaningOther
High flow is gradually weaned by reducing the flow rate
| Study group | Role | What they receive |
|---|---|---|
| Immediate ending | Experimental | High flow is ended immediately Receives: Other: High flow nasal cannula immediate ending |
| Weaning | Active comparator | High flow is ended by gradually reducing the flow rate Receives: Other: High flow nasal cannula weaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization time from randomization
Time in hours from the randomization to the time the family leaves hospital.
Measured: One week
Secondary outcomes (3)
Treatment failures
Need to restart the high flow therapy
Measured: One week
Readmission rate
Need for readmission
Measured: Seven days from discharge
Overall hospitalization time
The overall time, which includes the time interval prior to randomization
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start13 Feb 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute BronchiolitisStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Central Finland Hospital District, Mikkeli Central Hospital, Siun sote
- Responsible party
- Principal investigator, Ilari Kuitunen, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321133
- Sponsor's protocol ID
- 5402589
- Status last verified
- Aug 2025
- First submitted
- 13 Feb 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Flow Nasal Cannula Weaning in Acute Bronchiolitis - an Open-label Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT06321133
- Acronym / sponsor ID
- 5402589
- Conditions
- Acute Bronchiolitis
- Keywords
- Acute bronchiolitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- Central Finland Hospital District, Mikkeli Central Hospital, Siun sote
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Mar 2024 (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.
The goal of this clinical study is to compared two different strategies to end high flow nasal cannula treatment in acute bronchiolitis. This study compared the immediate ending of high flow treatment to weaning strategy, in which the flow rate is gradually decreased. The aim is to assess if the immediate ending shortens the hospitalization time and whether it is a safe strategy.
Detailed description
Acute bronchiolitis is the most common cause of hospitalization among infants in Finland, with its primary etiology being the RS- virus. Acute bronchiolitis is defined in Finland as an infant's first respiratory distress before the age of 1. There is no effective pharmacological treatment for acute bronchiolitis. High-flow nasal cannula therapy has been shown in large randomized trials to reduce the risk of intensive care unit admission for children. High-flow nasal cannulas are typically used at a flow rate of 2 liters per kilogram per minute. Despite widespread use, there is insufficient evidence to determine whether high-flow therapy should be discontinued abruptly or gradually tapered. Observational studies indicate that the majority of units opt for abrupt discontinuation. Common criteria for discontinuation include weaning off supplemental oxygen and maintaining normal oxygenation on room air for 4-6 hours. Gradual weaning has been shown in observational studies to prolong hospitalization compared to immediate cessation of therapy. In a randomized controlled trial conducted in a pediatric intensive care unit, direct discontinuation shortened the duration of treatment by up to two days. However, there have been no previous randomized trials conducted on bronchiolitis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate ending | Experimental | Other: High flow nasal cannula immediate endingHigh flow is ended immediately |
| Weaning | Active comparator | Other: High flow nasal cannula weaningHigh flow is ended by gradually reducing the flow rate |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Clinically diagnosed acute bronchiolitis
- High flow nasal cannula treatment has lasted for at least 12 hours
- Measured saturation 95 or more with room air
- High flow rate is maximum 2l/kg/min
- The treating doctors considers the infant suitable to be without high flow
Key exclusion criteria (3 listed)
- Major congenital anomaly of lungs, hearts or diaphragm
- Bacterial pneumonia
- Parents do not give consent
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 immediate endingHigh flow is immediately ended | Other | Immediate ending |
| High flow nasal cannula weaningHigh flow is gradually weaned by reducing the flow rate | Other | Weaning |
Primary outcome
Hospitalization time from randomization
Time frame: One week
Time in hours from the randomization to the time the family leaves hospital.
3 secondary outcomes
Treatment failures
Time frame: One week
Readmission rate
Time frame: Seven days from discharge
Overall hospitalization time
Time frame: One week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
- 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.
4 sites 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 immediate ending and High flow nasal cannula weaning in people with Acute Bronchiolitis, run by Kuopio University Hospital at 4 sites in Finland.
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 3 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: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Finland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilari Kuitunen, MD, PhD (+358447174910, ilari.kuitunen@uef.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization time from randomization (time frame: One week). 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 3 Sep 2025.