Actively Recruiting
High Flow Nasal Cannula Weaning in Acute Bronchiolitis - an Open-label Randomized Controlled Trial
Led by Kuopio University Hospital · Updated on 2025-09-03
50
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
K
Kuopio University Hospital
Lead Sponsor
C
Central Finland Hospital District
Collaborating Sponsor
AI-Summary
What this Trial Is About
The trial investigates two different ways to stop high flow nasal cannula treatment in infants with acute bronchiolitis, a common cause of hospitalization in young children. Researchers want to find out if stopping the therapy immediately is safe and helps to reduce hospital stay, compared to slowly reducing the flow rate. Acute bronchiolitis mainly affects infants under one year and currently has no effective medication treatment in Finland. Participants will receive one of two approaches: either the high flow nasal cannula is stopped immediately or the flow rate is gradually decreased until it ends. Typical high flow rates used are about 2 liters per kilogram per minute. The study compares these two strategies to see which method is more effective and safe for infants. During the study, infants will be monitored for treatment success, hospital stay length, and any readmissions within a week after discharge. Oxygen levels and suitability for ending therapy will be assessed by doctors. Researchers will measure hospitalization time starting from when they are assigned to a treatment method. The trial lasts for one week after randomization, with safety and treatment failure closely observed.
CONDITIONS
Brief Title
High Flow Nasal Cannula Weaning in Acute Bronchiolitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinically diagnosed acute bronchiolitis
- High flow nasal cannula treatment has lasted for at least 12 hours
- Measured oxygen saturation of 95% or more on room air
- High flow rate is a maximum of 2 liters per kilogram per minute
- Treating doctors consider the infant suitable to stop high flow therapy
You will not qualify if you...
- Major congenital anomaly of lungs, heart, or diaphragm
- Bacterial pneumonia
- Parents do not give consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until high flow therapy is stopped according to the assigned method
Participants receive high flow nasal cannula therapy which is either stopped immediately or gradually weaned by reducing the flow rate.
Visits as needed during high flow therapy discontinuation
Duration - Up to 1 week after randomization and 7 days from discharge
Participants are monitored for hospitalization time, treatment failure, and readmission after stopping high flow therapy.
Follow-up visits or contacts during the week after treatment
Trial Site Locations
Total: 4 locations
1
Siun Sote
Joensuu, Finland
Actively Recruiting
2
Central Finland Hospital District
Jyväskylä, Finland
Actively Recruiting
3
Kuopio University Hospital
Kuopio, Finland
Actively Recruiting
4
Mikkeli Central Hospital
Mikkeli, Finland
Actively Recruiting
Research Team
I
Ilari Kuitunen, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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