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

Not Applicable

Completed

• Conditions: Bronchiolitis
• Interventions: Device: treatment by 3l/min/kg in High Flow Nasal cannula (HFNC); Device: treatment by 2l/min/kg in High Flow Nasal cannula (HFNC)

• Registration Number: NCT02824744
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-27
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-01
• Study First Posted: 2016-07-07
• Study Start: 2016-11-02
• Primary Completion: 2017-03-17
• Study Completion: 2018-03
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment by 3l/min/kg in HFNC	treatment by 3l/min/kg in High Flow Nasal cannula (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)
treatment by 2l/min/kg in HFNC	treatment by 2l/min/kg in High Flow Nasal cannula (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)

Primary Outcome Measures

Name	Time	Method
Proportion of failure in both arms	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

Name	Time	Method
assessment of heart rate in both arm	up to 24 hours
number of participants with an aggravation of the clinical score for respiratory distress arms (mWCAS)	up to 24 hours
Assessment of the discomfort in both arms with the score of EDIN	up to 24 hours
assessment of the fraction of inspired oxygen (FiO2) in both arms	up to 24 hours	FiO2 required to achieve an oxygen saturation between 94 and 97%

Trial Locations

Locations (1)

University hospital of Montpellier; 🇫🇷 Montpellier, France