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

Bronchiolitis Clinical Trial

— TRAMONTANE2  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02824744
• Other study ID #: 9719
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 27, 2016
• Last updated: July 1, 2016
• Start date: October 2016
• Est. completion date: October 2017

Study information

• Verified date: July 2016
• Source: University Hospital, Montpellier
• Contact: Christophe MILESI, MD
• Phone: +33 4 67336609
• 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• age < 6 months

• bronchiolitis

• mWCAS > or =3

• hospitalisation: PICU

• signed consent form by parents

Exclusion Criteria:

• Intubated patient

• Neurological or cardiac disease

Study Design

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

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Device:
• treatment by 2l/min/kg in High Flow Nasal cannula (HFNC)

• treatment by 3l/min/kg in High Flow Nasal cannula (HFNC)

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 in both arms	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.	up to 24 hours	Yes
Secondary	assessment of heart rate in both arm		up to 24 hours	Yes
Secondary	Assessment of the discomfort in both arms with the score of EDIN		up to 24 hours	Yes
Secondary	assessment of the fraction of inspired oxygen (FiO2) in both arms	FiO2 required to achieve an oxygen saturation between 94 and 97%	up to 24 hours	Yes
Secondary	number of participants with an aggravation of the clinical score for respiratory distress arms (mWCAS)		up to 24 hours	No