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

NCT02824744 | Completed DMC

• 1 other identifier: 9719
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Keywords

Bronchiolitis; High flow nasal canula

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• assessment of heart rate in both arm

  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

• number of participants with an aggravation of the clinical score for respiratory distress arms (mWCAS)

  up to 24 hours

Study Arms (2)

treatment by 2l/min/kg in HFNC

ACTIVE COMPARATOR

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)

treatment by 3l/min/kg in HFNC

EXPERIMENTAL

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)

Interventions

treatment by 2l/min/kg in High Flow Nasal cannula (HFNC) DEVICE

treatment by 2l/min/kg in HFNC

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

treatment by 3l/min/kg in HFNC

Eligibility Criteria

• Age: 0 Hours - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Intubated patient
• Neurological or cardiac disease

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University hospital of Montpellier

Montpellier, 34285, France

Location

Related Publications (1)

• Milesi C, Pierre AF, Deho A, Pouyau R, Liet JM, Guillot C, Guilbert AS, Rambaud J, Millet A, Afanetti M, Guichoux J, Genuini M, Mansir T, Bergounioux J, Michel F, Marcoux MO, Baleine J, Durand S, Durand P, Dauger S, Javouhey E, Leteurtre S, Brissaud O, Renolleau S, Portefaix A, Douillard A, Cambonie G; GFRUP Respiratory Study Group. A multicenter randomized controlled trial of a 3-L/kg/min versus 2-L/kg/min high-flow nasal cannula flow rate in young infants with severe viral bronchiolitis (TRAMONTANE 2). Intensive Care Med. 2018 Nov;44(11):1870-1878. doi: 10.1007/s00134-018-5343-1. Epub 2018 Oct 21.

  PMID: 30343318 DERIVED

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2016
• First Posted: July 7, 2016
• Study Start: November 2, 2016
• Primary Completion: March 17, 2017
• Study Completion: March 1, 2018
• Last Updated: May 30, 2024

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)