High Flow Nasal Cannula Weaning in Acute Bronchiolitis

NCT ID: NCT06321133

Last Updated: 2025-09-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-13

Study Completion Date

2028-12-31

Brief Summary

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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

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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

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Acute Bronchiolitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Immediate ending

High flow is ended immediately

Group Type EXPERIMENTAL

High flow nasal cannula immediate ending

Intervention Type OTHER

High flow is immediately ended

Weaning

High flow is ended by gradually reducing the flow rate

Group Type ACTIVE_COMPARATOR

High flow nasal cannula weaning

Intervention Type OTHER

High flow is gradually weaned by reducing the flow rate

Interventions

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High flow nasal cannula immediate ending

High flow is immediately ended

Intervention Type OTHER

High flow nasal cannula weaning

High flow is gradually weaned by reducing the flow rate

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

0 Months

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Finland Hospital District

OTHER

Sponsor Role collaborator

Mikkeli Central Hospital

OTHER

Sponsor Role collaborator

Siun sote

UNKNOWN

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ilari Kuitunen

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Siun Sote

Joensuu, , Finland

Site Status RECRUITING

Central Finland Hospital District

Jyväskylä, , Finland

Site Status RECRUITING

Kuopio University Hospital

Kuopio, , Finland

Site Status RECRUITING

Mikkeli Central Hospital

Mikkeli, , Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Ilari Kuitunen, MD, PhD

Role: CONTACT

+358447174910

Facility Contacts

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Paula Widgren, MD, PhD

Role: primary

0045813 330 8285

Milla Pitkänen, MD

Role: primary

0035814 2691811

Ilari Kuitunen, MD, PhD

Role: primary

+358447174910

Marjo Renko, Professor

Role: backup

Nicole Weisshoff, MD

Role: primary

0035815 3511

Other Identifiers

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5402589

Identifier Type: -

Identifier Source: org_study_id

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