Comparison Between 2l vs 3l in HFNC During the Initial Management of Severe Bronchiolitis in Infants
NCT ID: NCT02824744
Last Updated: 2024-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
300 participants
INTERVENTIONAL
2016-11-02
2018-03-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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treatment by 2l/min/kg in 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)
treatment by 2l/min/kg in High Flow Nasal cannula (HFNC)
treatment by 3l/min/kg in 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 3l/min/kg in High Flow Nasal cannula (HFNC)
Interventions
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treatment by 2l/min/kg in High Flow Nasal cannula (HFNC)
treatment by 3l/min/kg in High Flow Nasal cannula (HFNC)
Eligibility Criteria
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Inclusion Criteria
* bronchiolitis
* mWCAS \> or =3
* hospitalisation: PICU
* signed consent form by parents
Exclusion Criteria
* Neurological or cardiac disease
0 Hours
6 Months
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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University hospital of Montpellier
Montpellier, , France
Countries
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References
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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.
Other Identifiers
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9719
Identifier Type: -
Identifier Source: org_study_id
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