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High Flow Nasal Cannula Use in Infants With Bronchiolitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02737280
Recruitment Status : Terminated (Slow recruitment)
First Posted : April 13, 2016
Last Update Posted : December 19, 2018
Sponsor:
Information provided by (Responsible Party):
Marjo Renko, University of Oulu

Tracking Information
First Submitted Date  ICMJE February 26, 2016
First Posted Date  ICMJE April 13, 2016
Last Update Posted Date December 19, 2018
Actual Study Start Date  ICMJE March 2016
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
Number of patients with treatment failure [ Time Frame: 720 hours ]
Treatment failure = need for change of respiratory support method
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
Respiratory rate (RR) measured by the study physician/nurse [ Time Frame: At 120 minutes ]
Change History Complete list of historical versions of study NCT02737280 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2017)
  • Respiratory rate measured by the study physician/nurse [ Time Frame: 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 ]
  • Time from randomisation to end of oxygen therapy [ Time Frame: 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
  • Respiratory rate measured by the study physician/nurse [ Time Frame: 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 ]
  • Modified Wood's Clinical Asthma Score (mWCAS) [ Time Frame: 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High Flow Nasal Cannula Use in Infants With Bronchiolitis
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bronchiolitis
Intervention  ICMJE
  • Device: Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy
    High flow nasal cannula therapy with Airvo (TM, Fisher & Paykel Healthcare) device
  • Device: MedKit Finland - Usual oxygen therapy
    Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min
Study Arms  ICMJE
  • Active Comparator: Usual oxygen therapy
    Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min
    Intervention: Device: MedKit Finland - Usual oxygen therapy
  • Experimental: High flow oxygen therapy
    High flow nasal cannula oxygen therapy with Airvo (TM, Fisher & Paykel Healthcare) device
    Intervention: Device: Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 17, 2018)
18
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2016)
84
Actual Study Completion Date  ICMJE September 2018
Actual Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 6 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02737280
Other Study ID Numbers  ICMJE EETTMK2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Marjo Renko, University of Oulu
Study Sponsor  ICMJE University of Oulu
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marjo Renko, MD, PhD University of Oulu
PRS Account University of Oulu
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP