High Flow Nasal Cannula Use in Infants With Bronchiolitis

University of Oulu

Status: Terminated

Conditions: Bronchiolitis

Treatments: Device: Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy; Device: MedKit Finland - Usual oxygen therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02737280

EETTMK2015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Admission to pediatric ward due to a presumed viral bronchiolitis
• Need of oxygen therapy (oxygen saturation < 92%)

Exclusion criteria

• Pertussis
• Needs intubation or CPAP on admission
• Severe congenital heart defect
• Down's syndrome

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Usual oxygen therapy

Active Comparator group

Description:

Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min

Treatment:

Device: MedKit Finland - Usual oxygen therapy

High flow oxygen therapy

Experimental group

Description:

High flow nasal cannula oxygen therapy with Airvo (TM, Fisher \& Paykel Healthcare) device

Treatment:

Device: Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy