High Flow Nasal Cannula Weaning in Acute Bronchiolitis | NCT06321133

Studies
High Flow Nasal Cannula Weaning in Acute Bronchiolitis

NCT06321133

Sponsor

Kuopio University Hospital

Status

Recruiting

Last Update Posted

Sep 3, 2025Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Acute Bronchiolitis

Interventions

High flow nasal cannula immediate ending
High flow nasal cannula weaning

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 13, 2024Actual

Primary Completion Date

Dec 31, 2028Estimated

Completion Date

Dec 31, 2028Estimated

First Submitted Date

Feb 13, 2024

First Submission Date that Met QC Criteria

Mar 17, 2024

First Posted Date

Mar 20, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 26, 2025

Last Update Posted Date

Sep 3, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ilari Kuitunen, Associate Professor, Kuopio University HospitalPrincipal Investigator

Lead Sponsor

Kuopio University HospitalOTHER

Collaborators

Name	Class
Central Finland Hospital District	OTHER
Mikkeli Central Hospital	OTHER
Siun sote	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Immediate ending	Experimental	High flow is ended immediately	Other: High flow nasal cannula immediate ending
Weaning	Active Comparator	High flow is ended by gradually reducing the flow rate	Other: High flow nasal cannula weaning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High flow nasal cannula immediate ending	Other	High flow is immediately ended	Immediate ending

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Treatment failures	Need to restart the high flow therapy	One week
Readmission rate	Need for readmission	Seven days from discharge

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Months

Maximum Age

12 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ilari Kuitunen, MD, PhD	Contact	+358447174910		ilari.kuitunen@uef.fi

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Siun Sote	Recruiting	Joensuu			Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided