High Flow Nasal Cannula Weaning in Acute Bronchiolitis

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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Bronchiolitis
• Intervention / Treatment: Other: High flow nasal cannula immediate ending; Other: High flow nasal cannula weaning

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilari Kuitunen, MD, PhD; Phone Number: +358447174910; Email: ilari.kuitunen@uef.fi

Study Locations

• Finland
  • Joensuu, Finland
    • Recruiting
    • Siun Sote
    • Contact: Paula Widgren, MD, PhD; Phone Number: 0045813 330 8285; Email: paula.widgren@siunsote.fi
  • Jyväskylä, Finland
    • Recruiting
    • Central Finland Hospital District
    • Contact: Milla Pitkänen, MD; Phone Number: 0035814 2691811; Email: milla.pitkanen@hyvaks.fi
  • Kuopio, Finland
    • Recruiting
    • Kuopio University Hospital
    • Sub-Investigator: Katri Backman, MD, PhD
    • Contact: Marjo Renko, Professor
    • Contact: Ilari Kuitunen, MD, PhD; Phone Number: +358447174910; Email: ilari.kuitunen@uef.fi
    • Sub-Investigator: Miika Arvonen, MD, PhD
  • Mikkeli, Finland
    • Recruiting
    • Mikkeli Central Hospital
    • Contact: Nicole Weisshoff, MD; Phone Number: 0035815 3511; Email: nicole.weisshoff@etelasavonha.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate ending; High flow is ended immediately	Other: High flow nasal cannula immediate ending; High flow is immediately ended
Active Comparator: Weaning; High flow is ended by gradually reducing the flow rate	Other: High flow nasal cannula weaning; High flow is gradually weaned by reducing the flow rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization time from randomization	Time in hours from the randomization to the time the family leaves hospital.	One week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment failures	Need to restart the high flow therapy	One week
Readmission rate	Need for readmission	Seven days from discharge
Overall hospitalization time	The overall time, which includes the time interval prior to randomization	One week

Collaborators and Investigators

• Sponsor: Kuopio University Hospital
• Collaborators: Central Finland Hospital District; Mikkeli Central Hospital; Siun sote

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: March 17, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Acute bronchiolitis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: 5402589

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No