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Interest of High Flow Nasal Cannula (HFNC) Versus Non Invasive Ventilation During the Initial Management of Severe Bronchiolitis in Infants (TRAMONTANE)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT02457013
First received: January 27, 2015
Last updated: May 26, 2015
Last verified: May 2015
  Purpose
  1. The purpose of the study is to evaluate prospectively the clinical benefits of High flow nasal canula (HFNC: 2l/kg/min) versus nasal CPAP( continuous positive airway pressure) (n-CPAP: 7 cmH2O) in the initial management of bronchiolitis in infants.
  2. Design: non-inferiority study, prospective, controlled, randomized, multi-center.
  3. Design: Infants less than 6 month admitted in pediatric intensive care unit for respiratory distress (mWCAS >3) secondary to bronchiolitis but not requiring mechanical ventilation will be randomized in two groups: "n-CPAP"(nasal continuous positive airway pressure) or "HFNC" during 24 hours.
  4. Conditions of measurements:

    Primary endpoint: Proportion of failure in both arms during the first 24 hours. Failure criteria: A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea.

    Secondary outcomes: Assessment at H1, H12, H24 of mWCAS, respiratory and heart rate, EDIN score, skin lesions, FiO2 (fraction of inspired oxygen

    ) required to achieve an oxygen saturation between 94 and 97%, transcutaneous PCO2 (carbon dioxide partial pressure) (correlated to an initial gas analysis), Report SpO2 / FiO2

  5. Statistic: Intention to treat Analysis. Expected number of patients: 71 per arm: 142 children.
  6. Study Schedule: October 2014-April 2016

Condition Intervention
Bronchiolitis
Device: HFNC
Device: nCPAP

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Interest of High Flow Nasal Cannula (HFNC) Versus Non Invasive Ventilation During the Initial Management of Severe Bronchiolitis in Infants

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Proportion of failure [ Time Frame: 24 hours ]
    Proportion of failure in both arms during the first 24 hours. A raise of the Clinical score for respiratory distress (mWCAS) (1 point) or respiratory rate (10/min /H0 and above 60/min) or discomfort (EDIN) (1point /H0 and above 4) or apnea.


Secondary Outcome Measures:
  • number of participants with an aggravation of the clinical score for respiratory distress arms [ Time Frame: 1hour ]
    comparison of the clinical score for respiratory distress (mWCAS) in both arms

  • number of participants with an aggravation of the clinical score for respiratory distress arms [ Time Frame: 12hours ]
    comparison of the clinical score for respiratory distress (mWCAS) in both arms

  • number of participants with an increase of the clinical score for respiratory distress arms [ Time Frame: 1 hour ]
    Assessment of Report Sp02/Fi02in both arms

  • Comparison of the Report Sp02/Fi02 in both arms [ Time Frame: 1 hour ]
    Assessment of Report Sp02/Fi02in both arms

  • Comparison of the Report Sp02/Fi02 in both arms [ Time Frame: 12 hours ]
    Assessment of Report Sp02/Fi02in both arms

  • Comparison of the Report Sp02/Fi02 in both arms [ Time Frame: 24 hours ]
    Assessment of Report Sp02/Fi02in both arms

  • number of participants with skin lesions in both arms [ Time Frame: 1 hour ]
    number of participants with skin lesions in both arms and classification of the lesions with the National Pressure Ulcer Advisory Panel (NPUAP)

  • number of participants with skin lesions in both arms [ Time Frame: 12 hours ]
    number of participants with skin lesions in both arms and classification of the lesions with the National Pressure Ulcer Advisory Panel (NPUAP)

  • number of participants with skin lesions in both arms [ Time Frame: 24 hours ]
    number of participants with skin lesions in both arms and classification of the lesions with the National Pressure Ulcer Advisory Panel (NPUAP)

  • number of participants with Discomfort in both arms [ Time Frame: 1 hour ]
    Assessment of the discomfort in both arms with the score of EDIN

  • number of participants with Discomfort in both arms [ Time Frame: 12 hours ]
    Assessment of the discomfort in both arms with the score of EDIN

  • number of participants with Discomfort in both arms [ Time Frame: 24 hours ]
    Assessment of the discomfort in both arms with the score of EDIN


Estimated Enrollment: 142
Study Start Date: October 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HFNC treatment
HFNC : High flow nasal canula 24hours Patients will be treated by a High flow nasal canula (HFNC: 2l/kg/min) for the initial management of their bronchiolitis (24 hours)
Device: HFNC
Hygh flow nasal canula HFNC
Active Comparator: nCPAP treatment
nCPAP : nasal NCPAP Patients will be treated by a nasal CPAP (n-CPAP: 7 cmH2O) for the initial management of their bronchiolitis (24 hours)
Device: nCPAP
nasal nCPAP

  Eligibility

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

Inclusion Criteria:

  • age<6months
  • bronchiolitis
  • mWCAS > or=3
  • hospitalisation in pediatric intensive care unit
  • signed consent form (2 parents)

Exclusion Criteria:

  • Intubated patient
  • Neurological or cardiac disease
  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: NCT02457013

Contacts
Contact: Christophe MILESI, Doctor 0033467336609 c-milesi@chu-montpellier.fr

Locations
France
University Hospital of Montpellier Recruiting
Montpellier, France, 34395
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02457013     History of Changes
Other Study ID Numbers: 9433
Study First Received: January 27, 2015
Last Updated: May 26, 2015

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 May 25, 2017