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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
High flow nasal cannula therapy with Airvo (TM, Fisher \& Paykel Healthcare) device
Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min
Central Hospital Jyväskylä
Jyväskylä, Finland
Oulu Unversity Hospital
Oulu, Finland
Seinäjoki Central Hospital
Seinäjoki, Finland
Tampere University Hospital
Tampere, Finland
Number of patients with treatment failure
Treatment failure = need for change of respiratory support method
Time frame: 720 hours
Respiratory rate measured by the study physician/nurse
Time frame: At 30 min, 60 min, 90 min, 4 hours, 8 hours
Oxygen saturation (%)
Time frame: At 30 min, 60 min, 90 min, 4 hours, 8 hours
Time from randomisation to end of oxygen therapy
Time frame: At 30 min, 60 min, 90 min, 4 hours, 8 hours
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.
Time frame: 720 hours
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.
Time frame: 720 hours
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