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

Bronchiolitis Clinical Trial

— TRAMONTANE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02457013
• Other study ID #: 9433
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2015
• Last updated: May 26, 2015
• Start date: October 2014
• Est. completion date: November 2016

Study information

• Verified date: May 2015
• Source: University Hospital, Montpellier
• Contact: Christophe MILESI, Doctor
• Phone: 0033467336609
• Email: c-milesi[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: November 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Device:
• HFNC
Hygh flow nasal canula HFNC
• nCPAP
nasal nCPAP

Locations

Country	Name	City	State
France	University Hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of failure	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.	24 hours	No
Secondary	number of participants with an aggravation of the clinical score for respiratory distress arms	comparison of the clinical score for respiratory distress (mWCAS) in both arms	1hour	No
Secondary	number of participants with an aggravation of the clinical score for respiratory distress arms	comparison of the clinical score for respiratory distress (mWCAS) in both arms	12hours	No
Secondary	number of participants with an increase of the clinical score for respiratory distress arms	Assessment of Report Sp02/Fi02in both arms	1 hour	No
Secondary	Comparison of the Report Sp02/Fi02 in both arms	Assessment of Report Sp02/Fi02in both arms	1 hour	No
Secondary	Comparison of the Report Sp02/Fi02 in both arms	Assessment of Report Sp02/Fi02in both arms	12 hours	No
Secondary	Comparison of the Report Sp02/Fi02 in both arms	Assessment of Report Sp02/Fi02in both arms	24 hours	No
Secondary	number of participants with skin lesions in both arms	number of participants with skin lesions in both arms and classification of the lesions with the National Pressure Ulcer Advisory Panel (NPUAP)	1 hour	No
Secondary	number of participants with skin lesions in both arms	number of participants with skin lesions in both arms and classification of the lesions with the National Pressure Ulcer Advisory Panel (NPUAP)	12 hours	No
Secondary	number of participants with skin lesions in both arms	number of participants with skin lesions in both arms and classification of the lesions with the National Pressure Ulcer Advisory Panel (NPUAP)	24 hours	No
Secondary	number of participants with Discomfort in both arms	Assessment of the discomfort in both arms with the score of EDIN	1 hour	No
Secondary	number of participants with Discomfort in both arms	Assessment of the discomfort in both arms with the score of EDIN	12 hours	No
Secondary	number of participants with Discomfort in both arms	Assessment of the discomfort in both arms with the score of EDIN	24 hours	No