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NCT Number: NCT06321133

High Flow Nasal Cannula Weaning in Acute Bronchiolitis

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.

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Key information

Conditions

Age range

0 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siun Sote, Joensuu, Finland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Major congenital anomaly of lungs, hearts or diaphragm
  • Bacterial pneumonia
  • Parents do not give consent

Treatment and study plan

High flow nasal cannula immediate ending

Other

High flow is immediately ended

High flow nasal cannula weaning

Other

High flow is gradually weaned by reducing the flow rate

Primary outcomes

  1. Hospitalization time from randomization

    Time frame: One week

    Time in hours from the randomization to the time the family leaves hospital.

Secondary outcomes

  1. Treatment failures

    Time frame: One week

    Need to restart the high flow therapy

  2. Readmission rate

    Time frame: Seven days from discharge

    Need for readmission

  3. Overall hospitalization time

    Time frame: One week

    The overall time, which includes the time interval prior to randomization

Study contacts

Contact information is provided by the study sponsor or research team.

Ilari Kuitunen, MD, PhD

CONTACT

[email protected]

+358447174910

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • Central Finland Hospital District
  • Mikkeli Central Hospital
  • Siun sote

Registry information

Official study title

High Flow Nasal Cannula Weaning in Acute Bronchiolitis - an Open-label Randomized Controlled Trials

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Mar 20, 2024
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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