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High Flow Nasal Cannula Use in Infants With Bronchiolitis

This study is currently recruiting participants.
See Contacts and Locations
Verified October 2016 by Marjo Renko, University of Oulu
Sponsor:
Information provided by (Responsible Party):
Marjo Renko, University of Oulu
ClinicalTrials.gov Identifier:
NCT02737280
First received: February 26, 2016
Last updated: October 24, 2016
Last verified: October 2016
  Purpose
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 Intervention
Bronchiolitis Device: Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy Device: MedKit Finland - Usual oxygen therapy

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Marjo Renko, University of Oulu:

Primary Outcome Measures:
  • Respiratory rate (RR) measured by the study physician/nurse [ Time Frame: At 120 minutes ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 84
Study Start Date: March 2016
Estimated Study Completion Date: March 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 two pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.

The investigators will recruit 84 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 the respiratory rate (RR) 120 minutes after starting oxygen therapy. Secondary endpoints are RR, oxygen saturation (%) and modified Wood's Clinical Asthma Score (mWCAS) at specific measuring points, time to discharge and admission to intensive care unit (ICU).

  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02737280

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

Locations
Finland
Oulu Unversity Hospital Not yet 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         
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
Study First Received: February 26, 2016
Last Updated: October 24, 2016
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

ClinicalTrials.gov processed this record on August 18, 2017