NCT02737280

High Flow Nasal Cannula Use in Infants With Bronchiolitis

High Flow Humified Nasal Cannula Oxygen Therapy in Infants Younger Than 6 Months of Age With Viral Bronchiolitis Compared to Usual Oxygen Therapy : a Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Oulu · Academic / Other
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

Summary

Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in two pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis.

Detailed description

Infants with viral bronchiolitis are currently treated with oxygen therapy if oxygen saturation is low. In earlier observational clinical studies, the use of high flow nasal cannulae therapy in infants with bronchiolitis has been associated with a decreased rate of intubation and intensive care. This study is a randomized controlled trial in five pediatric university hospitals in Finland comparing high flow nasal cannulae therapy to usual oxygen therapy in infants with bronchiolitis. The investigators will recruit 160 infants who require oxygen therapy (oxygen saturation \<92%) during hospitalization due to a viral bronchiolitis. The participants are randomized to receive oxygen therapy either with high flow or ordinary nasal cannula.The infants are closely observed by study physicians for clinical parameters. The primary end point is treatment failure (need for change of respiratory support method). Secondary endpoints are respiratory rate (RR) and oxygen saturation (%) at specific measuring points, time from randomisation to end of oxygen therapy and time from randomisation to discharge.

Conditions

• Bronchiolitis

Interventions

Type	Name	Description
DEVICE	Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy	High flow nasal cannula therapy with Airvo (TM, Fisher \& Paykel Healthcare) device
DEVICE	MedKit Finland - Usual oxygen therapy	Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min

Timeline

• Start date: 2016-03-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2016-04-13
• Last updated: 2018-12-19

Locations

4 sites across 1 country: Finland