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Comparison Between 2l vs 3l in HFNC During the Initial Management of Severe Bronchiolitis in Infants (TRAMONTANE2)

This study is not yet open for participant recruitment.
Verified July 2016 by University Hospital, Montpellier
Sponsor:
ClinicalTrials.gov Identifier:
NCT02824744
First Posted: July 7, 2016
Last Update Posted: July 7, 2016
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Montpellier
  Purpose

The purpose of the study is to evaluate prospectively the clinical benefits of 2 different flow with High flow nasal canula (HFNC: 2l/kg/min) versus (HFNC: 2l/kg/min) in the initial management of bronchiolitis in infants.

Design: Prospective, controlled, randomized, multi-center.

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:HFNC "2l/min/kg" or HFNC "3l/min/kg" during 24 hours.

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

Statistic: Intention to treat Analysis.

Expected number of patients: 135 per arm: 270 children.


Condition Intervention Phase
Bronchiolitis Device: treatment by 2l/min/kg in High Flow Nasal cannula (HFNC) Device: treatment by 3l/min/kg in High Flow Nasal cannula (HFNC) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between 2l/Min/kg vs 3l/Min/kg in High Flow Nasal Cannula (HFNC) During the Initial Management of Severe Bronchiolitis in Infants

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Proportion of failure in both arms [ Time Frame: up to 24 hours ]
    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 Outcome Measures:
  • assessment of heart rate in both arm [ Time Frame: up to 24 hours ]
  • Assessment of the discomfort in both arms with the score of EDIN [ Time Frame: up to 24 hours ]
  • assessment of the fraction of inspired oxygen (FiO2) in both arms [ Time Frame: up to 24 hours ]
    FiO2 required to achieve an oxygen saturation between 94 and 97%

  • number of participants with an aggravation of the clinical score for respiratory distress arms (mWCAS) [ Time Frame: up to 24 hours ]

Estimated Enrollment: 270
Study Start Date: October 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: treatment by 2l/min/kg in HFNC
treatment by 2l/min/kg in High Flow Nasal cannula (HFNC) during the initial management of severe bronchiolitis in infants (0-6 months years old)
Device: treatment by 2l/min/kg in High Flow Nasal cannula (HFNC)
Experimental: treatment by 3l/min/kg in HFNC
treatment by 3l/min/kg in High Flow Nasal cannula (HFNC) during the initial management of severe bronchiolitis in infants (0-6 months years old)
Device: treatment by 3l/min/kg in High Flow Nasal cannula (HFNC)

  Eligibility

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:

  • age < 6 months
  • bronchiolitis
  • mWCAS > or =3
  • hospitalisation: PICU
  • signed consent form by parents

Exclusion Criteria:

  • Intubated patient
  • Neurological or cardiac disease
  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): NCT02824744


Contacts
Contact: Christophe MILESI, MD +33 4 67336609 c-milesi@chu-montpellier.fr

Locations
France
University hospital of Montpellier Not yet recruiting
Montpellier, France, 34285
Contact: CHRISTOPHE MILESI, MD    0033 4 67336609    c-milesi@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02824744     History of Changes
Other Study ID Numbers: 9719
First Submitted: June 27, 2016
First Posted: July 7, 2016
Last Update Posted: July 7, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data will be centralized at the sponsor office for the final analysis

Keywords provided by University Hospital, Montpellier:
Bronchiolitis
High flow nasal canula

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