High Flow Nasal Cannula Weaning in Acute Bronchiolitis

Last updated: March 17, 2024
Sponsor: Kuopio University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv) Infection

Bronchitis (Pediatric)

Treatment

High flow nasal cannula weaning

High flow nasal cannula immediate ending

Clinical Study ID

NCT06321133
5402589
  • Ages < 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: High flow nasal cannula weaning
Phase:
Study Start date:
February 13, 2024
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Siun Sote

    Joensuu,
    Finland

    Active - Recruiting

  • Central Finland Hospital District

    Jyväskylä,
    Finland

    Active - Recruiting

  • Kuopio University Hospital

    Kuopio,
    Finland

    Active - Recruiting

  • Mikkeli Central Hospital

    Mikkeli,
    Finland

    Active - Recruiting

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