Over the last decade, high-flow nasal oxygen therapy (HFN) has emerged as a new method to provide respiratory support in children with moderate to severe bronchiolitis. However, any randomized clinical trial (RCT) have demonstrated that earlier support with HFN is superior to standard care including low -flow nasal oxygen therapy to reduce the risk of acute respiratory failure requiring non invasive (or tracheal) ventilation and subsequently the need of PICU transfer.
Open label, non-blinded multi-centre, randomised controlled trial comparing standard care including oxygen delivery via HFN versus standard nasal oxygen therapy in infants admitted to hospital with moderate-to-severe bronchiolitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
268
High-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (F\&P, NZ) at initial flow to 3l/kg/min (up to a maximum of 20l/min), FiO2 adjusted for SpO2 \> 94%.
flow adjusted to SpO2 \> 94% (up to a maximum of 2l/min).
AP-HP, Bicêtre Hospital
Le Kremlin-Bicêtre, France
patient in treatment failure in each group (control or HFN) requiring non-invasive (or endotracheal) ventilation and ventilation-support free days
Treatment failure is defined if one or more following criteria are met: refractory apnea (\> 3/h), oxygen requirement in HFN therapy arm exceeds fraction of inspired oxygen (FiO2) ≥ 40 % or oxygen requirement in standard nasal oxygen therapy arm exceeds \>2l/min to maintain oxygen saturation (SpO2) ≥94 %), m-WCAS score increased compared to admission at H6 and/or \> 5 , PaCO2 (H6 ) increased compared to admission and \> 60-70 mmHg.
Time frame: Up to an average of 7 days
Transfer to pediatrics intensive care unit (PICU)
Numbers of infants transferred to PICU in each arm
Time frame: at the end of the follow up (an average of 7 days)
Length of stay in paediatric general ward unit
number of days between the enrolment and return to home or the transfer to PICU when appropriate (treatment failure)
Time frame: at the end of the follow up (an average of 7 days)
Oxgen-support free days
number of oxygen support free days
Time frame: at the end of the follow up (an average of 7 days)
Artificial nutritional-support free days
number of artificial nutritional-support free days (enteral feeding or intravenous line)
Time frame: at the end of the follow up (an average of 7 days)
Assessment of short term respiratory status
Sequential assessment of short term (H1, 6, 12, 24) respiratory status including respiratory rate, heart-rate, SpO2, m-WCAS score, transcutaneous carbon dioxide partial pressure (tcPaCO2).
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Time frame: at the end of the follow up (an average of 7 days)