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High Flow Nasal Cannula Use in Infants With Bronchiolitis

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ClinicalTrials.gov Identifier: NCT02737280
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Bronchiolitis Device: Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy Device: MedKit Finland - Usual oxygen therapy

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oxygen Therapy
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Number of patients with treatment failure [ Time Frame: 720 hours ]
    Treatment failure = need for change of respiratory support method


Secondary Outcome Measures :
  1. Respiratory rate measured by the study physician/nurse [ Time Frame: At 30 min, 60 min, 90 min, 4 hours, 8 hours ]
  2. Oxygen saturation (%) [ Time Frame: At 30 min, 60 min, 90 min, 4 hours, 8 hours ]
  3. Time from randomisation to end of oxygen therapy [ Time Frame: At 30 min, 60 min, 90 min, 4 hours, 8 hours ]
  4. 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.

  5. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737280


Contacts
Contact: Marjo Renko, MD, PhD +358-8-3155132 marjo.renko@oulu.fi
Contact: Terhi Tapiainen, MD, PhD +358-8-3155185

Locations
Finland
Central Hospital Jyväskylä Recruiting
Jyväskylä, Finland
Contact: Eva Aaltonen, MD         
Oulu Unversity Hospital Recruiting
Oulu, Finland
Contact: Marjo Renko, MD, PhD       marjo.renko@oulu.fi   
Contact: Terhi Tapiainen, MD, PhD       terhi.tapiainen@oulu.fi   
Principal Investigator: Marjo Renko, MD, PhD         
Sub-Investigator: Terhi Tapiainen, MD, PhD         
Seinäjoki Central Hospital Recruiting
Seinäjoki, Finland
Contact: Kirsi Nuolivirta, docent         
Tampere University Hospital Recruiting
Tampere, Finland
Contact: Matti Korppi, MD, PhD       matti.korppi@uta.fi   
Sponsors and Collaborators
University of Oulu
Investigators
Principal Investigator: Marjo Renko, MD, PhD University of Oulu
More Information

Responsible Party: Marjo Renko, MD, PhD, University of Oulu
ClinicalTrials.gov Identifier: NCT02737280     History of Changes
Other Study ID Numbers: EETTMK2015
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Marjo Renko, University of Oulu:
infant
high flow nasal cannulae
oxygen therapy
bronchiolitis

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections