Clinical trial NCT02856165: High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis
Official title: High-flow Nasal Oxygen Therapy (Optiflow) in Hospitalized Infant With Moderate-to-severe Bronchiolitis: Multicentric Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: infant
oxygen therapy
High flow nasal canula oxygen therapy
Bronchiolitis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2016-08-04
Enrollment: 268
Sex: ALL
Minimum age (years): 7
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* first episode of hospitalised bronchiolitis (as defined by American Academy of Pediatrics clinical criterions )
* aged 7 days- 6 months
* transcutaneous SpO2 in room air \< 95%
* modified Wood's Clinical Asthma Score (m-WCAS) ≥ 2 et ≤ 5
* agreement of at least one of the parents or legal tutor for his child to participate in biomedical research
* affiliation to social security (beneficiary or entitled), except beneficiary of State medical help

Exclusion Criteria:

* Urgent need for mechanical ventilation support either by nCPAP ou endotracheal route
* Severe form defined by modified Wood's Clinical Asthma Score (mWCAS) exceeding 5 or 6, requiring non invasive ventilation (n CPAP)
* Uncorrected cyanotic heart disease, innate immune deficiency, cranio-facial malformation, congenital stridor, tracheotomy
* Inclusion in other observational study.

Primary outcomes:
measure: patient in treatment failure in each group (control or HFN) requiring non-invasive (or endotracheal) ventilation and ventilation-support free days
timeFrame: Up to an average of 7 days
Secondary outcomes:
measure: Transfer to pediatrics intensive care unit (PICU)
timeFrame: at the end of the follow up (an average of 7 days)
measure: Length of stay in paediatric general ward unit
timeFrame: at the end of the follow up (an average of 7 days)
measure: Oxgen-support free days
timeFrame: at the end of the follow up (an average of 7 days)
measure: Artificial nutritional-support free days
timeFrame: at the end of the follow up (an average of 7 days)
measure: Assessment of short term respiratory status
timeFrame: at the end of the follow up (an average of 7 days)
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
facility: AP-HP, Bicêtre Hospital
Study officials:
affiliation: AP-HP, Bicêtre Hospital
name: Philippe DURAND, MD
role: PRINCIPAL_INVESTIGATOR
References: