Clinical trial NCT06321133: High Flow Nasal Cannula Weaning in Acute Bronchiolitis
Official title: High Flow Nasal Cannula Weaning in Acute Bronchiolitis - an Open-label Randomized Controlled Trials
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Bronchiolitis
Keywords: Acute bronchiolitis
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: Central Finland Hospital District
name: Mikkeli Central Hospital
name: Siun sote
First posted: 2024-03-20
Enrollment: 50
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hospitalization time from randomization
timeFrame: One week
Secondary outcomes:
measure: Treatment failures
timeFrame: One week
measure: Readmission rate
timeFrame: Seven days from discharge
measure: Overall hospitalization time
timeFrame: One week
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: Siun Sote
city: Jyväskylä
country: Finland
facility: Central Finland Hospital District
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Mikkeli
country: Finland
facility: Mikkeli Central Hospital
Study officials:
References: