Actively Recruiting

Phase Not Applicable
Age: 0Months - 12Months
All Genders
ID06321133

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

Age: 0Months - 12Months
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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