High Flow Nasal Cannula Weaning in Acute Bronchiolitis

Acute Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321133
• Other study ID #: 5402589
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Kuopio University Hospital
• Contact: Ilari Kuitunen, MD, PhD
• Phone: +358447174910
• Email: ilari.kuitunen[@]uef.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Months to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Acute Bronchiolitis
• Bronchiolitis

Intervention

Other:
• High flow nasal cannula immediate ending
High flow is immediately ended
• High flow nasal cannula weaning
High flow is gradually weaned by reducing the flow rate

Locations

Country	Name	City	State
Finland	Siun Sote	Joensuu
Finland	Central Finland Hospital District	Jyväskylä
Finland	Kuopio University Hospital	Kuopio
Finland	Mikkeli Central Hospital	Mikkeli

Sponsors (4)

Lead Sponsor	Collaborator
Kuopio University Hospital	Central Finland Hospital District, Mikkeli Central Hospital, Siun sote

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization time from randomization	Time in hours from the randomization to the time the family leaves hospital.	One week
Secondary	Treatment failures	Need to restart the high flow therapy	One week
Secondary	Readmission rate	Need for readmission	Seven days from discharge
Secondary	Overall hospitalization time	The overall time, which includes the time interval prior to randomization	One week