High Flow Nasal Cannula Use in Infants With Bronchiolitis

Not Applicable

Terminated

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

• Registration Number: NCT02737280
• Lead Sponsor: University of Oulu

Brief 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.

Study Timeline

• Study First Submitted: 2016-02-26
• Study Start: 2016-03
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-13
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-17
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of patients with treatment failure	720 hours	Treatment failure = need for change of respiratory support method

Secondary Outcome Measures

Name	Time	Method
Oxygen saturation (%)	At 30 min, 60 min, 90 min, 4 hours, 8 hours
Number of participants needing admission to intensive care unit (ICU)	720 hours	The number of participants needing admission to intensive care unit (ICU) will be registered in both treatment groups and that number divided by the total number of participants in the groups (percentages) are then compared between the study groups.
Time from randomisation to end of oxygen therapy	At 30 min, 60 min, 90 min, 4 hours, 8 hours
Time from hospital admission to discharge (hours)	720 hours	The date and time for admission and discharge will be registered for each participant and time from hospital admission to discharge is then calculated in hours and compared between the study groups.
Respiratory rate measured by the study physician/nurse	At 30 min, 60 min, 90 min, 4 hours, 8 hours

Trial Locations

Locations (4)

Central Hospital Jyväskylä; 🇫🇮 Jyväskylä, Finland

Oulu Unversity Hospital; 🇫🇮 Oulu, Finland

Seinäjoki Central Hospital; 🇫🇮 Seinäjoki, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland