High Flow Nasal Cannula Weaning in Acute Bronchiolitis
1 other identifier
interventional
50
1 country
4
Brief 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. The aim is to assess if the immediate ending shortens the hospitalization time and whether it is a safe strategy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2024
Longer than P75 for not_applicable
4 active sites
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
February 13, 2024
CompletedStudy Start
First participant enrolled
February 13, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
September 3, 2025
August 1, 2025
4.9 years
February 13, 2024
August 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospitalization time from randomization
Time in hours from the randomization to the time the family leaves hospital.
One week
Secondary Outcomes (3)
Treatment failures
One week
Readmission rate
Seven days from discharge
Overall hospitalization time
One week
Study Arms (2)
Immediate ending
EXPERIMENTALHigh flow is ended immediately
Weaning
ACTIVE COMPARATORHigh flow is ended by gradually reducing the flow rate
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Major congenital anomaly of lungs, hearts or diaphragm
- Bacterial pneumonia
- Parents do not give consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kuopio University Hospitallead
- Central Finland Hospital Districtcollaborator
- Mikkeli Central Hospitalcollaborator
- Siun sotecollaborator
Study Sites (4)
Siun Sote
Joensuu, Finland
Central Finland Hospital District
Jyväskylä, Finland
Kuopio University Hospital
Kuopio, Finland
Mikkeli Central Hospital
Mikkeli, Finland
Central Study Contacts
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
- Associate Professor
Study Record Dates
First Submitted
February 13, 2024
First Posted
March 20, 2024
Study Start
February 13, 2024
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
September 3, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share