High Flow Nasal Cannula Use in Infants With Bronchiolitis

Bronchiolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02737280
• Other study ID #: EETTMK2015
• Status: Terminated
• Phase: N/A
• Start date: March 2016
• Est. completion date: September 2018

Study information

• Verified date: December 2018
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

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

Locations

Country	Name	City	State
Finland	Central Hospital Jyväskylä	Jyväskylä
Finland	Oulu Unversity Hospital	Oulu
Finland	Seinäjoki Central Hospital	Seinäjoki
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with treatment failure	Treatment failure = need for change of respiratory support method	720 hours
Secondary	Respiratory rate measured by the study physician/nurse		At 30 min, 60 min, 90 min, 4 hours, 8 hours
Secondary	Oxygen saturation (%)		At 30 min, 60 min, 90 min, 4 hours, 8 hours
Secondary	Time from randomisation to end of oxygen therapy		At 30 min, 60 min, 90 min, 4 hours, 8 hours
Secondary	Time from hospital admission to discharge (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.	720 hours
Secondary	Number of participants needing admission to intensive care unit (ICU)	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.	720 hours