High-flow Nasal Oxygen Therapy in Hospitalized Infant With Moderate-to-severe Bronchiolitis (BRONCHOPTI)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Bronchiolitis

Treatments: Device: Low-flow oxygen therapy with standard nasal canula; Device: High-flow nasal canula oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02856165

P150931

Details and patient eligibility

About

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.

Full 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.

Enrollment: 268 patients

Sex: All

Ages: 7 days to 6 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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268 participants in 2 patient groups

High-flow nasal canula oxygen therapy

Experimental group

Description:

High-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (Fisher\&Paykel (F\&P), NZ)

Treatment:

Device: High-flow nasal canula oxygen therapy

Low-flow oxygen therapy

Active Comparator group

Description:

Low-flow oxygen therapy with standard nasal canula

Treatment:

Device: Low-flow oxygen therapy with standard nasal canula