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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02457013

Acronym

TRAMONTANE

Enrollment

142

Registered

2015-05-29

Start date

2014-10-31

Completion date

2016-11-30

Last updated

2015-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

Brief 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

Interventions

DEVICEHFNC

Hygh flow nasal canula HFNC

DEVICEnCPAP

nasal nCPAP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 6 Months

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Proportion of failure	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

Measure	Time frame	Description
Comparison of the Report Sp02/Fi02 in both arms	1 hour	Assessment of Report Sp02/Fi02in both arms
number of participants with an aggravation of the clinical score for respiratory distress arms	1hour	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	1 hour	Assessment of Report Sp02/Fi02in both arms
number of participants with skin lesions in both arms	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 Discomfort in both arms	1 hour	Assessment of the discomfort in both arms with the score of EDIN

Countries

France

Contacts

Primary ContactChristophe MILESI, Doctor

c-milesi@chu-montpellier.fr0033467336609

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026