High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis (BRONCHOPTI)
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|ClinicalTrials.gov Identifier: NCT02856165|
Recruitment Status : Recruiting
First Posted : August 4, 2016
Last Update Posted : March 1, 2017
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.
|Condition or disease||Intervention/treatment|
|Bronchiolitis||Device: High-flow nasal canula oxygen therapy Device: Low-flow oxygen therapy with standard nasal canula|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||276 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||High-flow Nasal Oxygen Therapy (Optiflow) in Hospitalized Infant With Moderate-to-severe Bronchiolitis: Multicentric Randomized Controlled Trial|
|Study Start Date :||October 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||April 2018|
Experimental: High-flow nasal canula oxygen therapy
High-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (Fisher&Paykel (F&P), NZ)
Device: High-flow nasal canula oxygen therapy
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%.
Other Name: Optiflow
Active Comparator: Low-flow oxygen therapy
Low-flow oxygen therapy with standard nasal canula
Device: Low-flow oxygen therapy with standard nasal canula
flow adjusted to SpO2 > 94% (up to a maximum of 2l/min).
Other Name: Low-flow oxygen therapy
- patient in treatment failure in each group (control or HFN) requiring non-invasive (or endotracheal) ventilation and ventilation-support free days [ Time Frame: Up to an average of 7 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.
- Transfer to pediatrics intensive care unit (PICU) [ Time Frame: at the end of the follow up (an average of 7 days) ]Numbers of infants transferred to PICU in each arm
- Length of stay in paediatric general ward unit [ Time Frame: at the end of the follow up (an average of 7 days) ]number of days between the enrolment and return to home or the transfer to PICU when appropriate (treatment failure)
- Oxgen-support free days [ Time Frame: at the end of the follow up (an average of 7 days) ]number of oxygen support free days
- Artificial nutritional-support free days [ Time Frame: at the end of the follow up (an average of 7 days) ]number of artificial nutritional-support free days (enteral feeding or intravenous line)
- Assessment of short term respiratory status [ Time Frame: at the end of the follow up (an average of 7 days) ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856165
|Contact: Philippe DURAND, MD||00 33 1 45 21 72 firstname.lastname@example.org|
|Contact: Vincent GAJDOS, MD, PhDemail@example.com|
|AP-HP, Bicêtre Hospital||Recruiting|
|Le Kremlin Bicêtre, France, 94270|
|Contact: Irina CRAIU, MD 00 33 1 45 21 31 44 firstname.lastname@example.org|
|Principal Investigator:||Philippe DURAND, MD||AP-HP, Bicêtre Hospital|