NCT02856165

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

High-flow Nasal Oxygen Therapy (Optiflow) in Hospitalized Infant With Moderate-to-severe Bronchiolitis: Multicentric Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 268 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 7 Days – 6 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Bronchiolitis

Interventions

Type	Name	Description
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%.
DEVICE	Low-flow oxygen therapy with standard nasal canula	flow adjusted to SpO2 \> 94% (up to a maximum of 2l/min).

Timeline

• Start date: 2016-10-28
• Primary completion: 2017-11-15
• Completion: 2017-11-23
• First posted: 2016-08-04
• Last updated: 2018-04-30

Locations

1 site across 1 country: France