Clinical Trials Directory

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RecruitingNCT06321133

High Flow Nasal Cannula Weaning in Acute Bronchiolitis

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
50 (estimated)
Sponsor
Kuopio University Hospital · Academic / Other
Sex
All
Age
0 Months – 12 Months
Healthy volunteers
Not accepted

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.

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

Interventions

TypeNameDescription
OTHERHigh flow nasal cannula immediate endingHigh flow is immediately ended
OTHERHigh flow nasal cannula weaningHigh flow is gradually weaned by reducing the flow rate

Timeline

Start date
2024-02-13
Primary completion
2028-12-31
Completion
2028-12-31
First posted
2024-03-20
Last updated
2025-09-03

Locations

4 sites across 1 country: Finland

Source: ClinicalTrials.gov record NCT06321133. Inclusion in this directory is not an endorsement.