High Flow Nasal Cannula Use in Infants With Bronchiolitis

December 17, 2018 updated by: Marjo Renko, University of Oulu

High Flow Humified Nasal Cannula Oxygen Therapy in Infants Younger Than 6 Months of Age With Viral Bronchiolitis Compared to Usual Oxygen Therapy : a Randomized Controlled Trial

Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in two pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in five pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.

The investigators will recruit 160 infants who require oxygen therapy (oxygen saturation <92%) during hospitalization due to a viral bronchiolitis. The participants are randomized to receive oxygen therapy either with high flow or ordinary nasal cannula.The infants are closely observed by study physicians for clinical parameters. The primary end point is treatment failure (need for change of respiratory support method). Secondary endpoints are respiratory rate (RR) and oxygen saturation (%) at specific measuring points, time from randomisation to end of oxygen therapy and time from randomisation to discharge.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Jyväskylä, Finland
        • Central Hospital Jyväskylä
      • Oulu, Finland
        • Oulu Unversity Hospital
      • Seinäjoki, Finland
        • Seinäjoki Central Hospital
      • Tampere, Finland
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 10 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Admission to pediatric ward due to a presumed viral bronchiolitis
  • Need of oxygen therapy (oxygen saturation < 92%)

Exclusion Criteria:

  • Pertussis
  • Needs intubation or CPAP on admission
  • Severe congenital heart defect
  • Down's syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual oxygen therapy
Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min
Device: MedKit Finland - Usual oxygen therapy
Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min
Experimental: High flow oxygen therapy
High flow nasal cannula oxygen therapy with Airvo (TM, Fisher & Paykel Healthcare) device
Device: Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy
High flow nasal cannula therapy with Airvo (TM, Fisher & Paykel Healthcare) device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with treatment failure
Time Frame: 720 hours
Treatment failure = need for change of respiratory support method
720 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory rate measured by the study physician/nurse
Time Frame: At 30 min, 60 min, 90 min, 4 hours, 8 hours
At 30 min, 60 min, 90 min, 4 hours, 8 hours
Oxygen saturation (%)
Time Frame: At 30 min, 60 min, 90 min, 4 hours, 8 hours
At 30 min, 60 min, 90 min, 4 hours, 8 hours
Time from randomisation to end of oxygen therapy
Time Frame: At 30 min, 60 min, 90 min, 4 hours, 8 hours
At 30 min, 60 min, 90 min, 4 hours, 8 hours
Time from hospital admission to discharge (hours)
Time Frame: 720 hours
The date and time for admission and discharge will be registered for each participant and time from hospital admission to discharge is then calculated in hours and compared between the study groups.
720 hours
Number of participants needing admission to intensive care unit (ICU)
Time Frame: 720 hours
The number of participants needing admission to intensive care unit (ICU) will be registered in both treatment groups and that number divided by the total number of participants in the groups (percentages) are then compared between the study groups.
720 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Investigators

  • Principal Investigator: Marjo Renko, MD, PhD, University of Oulu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 13, 2016

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 17, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EETTMK2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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