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Completed

NCT Number: NCT02824744

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

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.

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Key information

Conditions

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

Age range

0 hour–6 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University hospital of Montpellier

Montpellier, 34285, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Intubated patient
  • Neurological or cardiac disease

Treatment and study plan

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

Device

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

Device

Primary outcomes

  1. Proportion of failure in both arms

    Time frame: 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 outcomes

  1. assessment of heart rate in both arm

    Time frame: up to 24 hours

  2. Assessment of the discomfort in both arms with the score of EDIN

    Time frame: up to 24 hours

  3. assessment of the fraction of inspired oxygen (FiO2) in both arms

    Time frame: up to 24 hours

    FiO2 required to achieve an oxygen saturation between 94 and 97%

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

    Time frame: up to 24 hours

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study 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

Acronym: TRAMONTANE2

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 7, 2016
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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