Clinical trial NCT02737280: High Flow Nasal Cannula Use in Infants With Bronchiolitis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchiolitis
Keywords: infant
high flow nasal cannulae
oxygen therapy
bronchiolitis
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2016-04-13
Enrollment: 18
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with treatment failure
timeFrame: 720 hours
Secondary outcomes:
measure: Respiratory rate measured by the study physician/nurse
timeFrame: At 30 min, 60 min, 90 min, 4 hours, 8 hours
measure: Oxygen saturation (%)
timeFrame: At 30 min, 60 min, 90 min, 4 hours, 8 hours
measure: Time from randomisation to end of oxygen therapy
timeFrame: At 30 min, 60 min, 90 min, 4 hours, 8 hours
measure: Time from hospital admission to discharge (hours)
timeFrame: 720 hours
measure: Number of participants needing admission to intensive care unit (ICU)
timeFrame: 720 hours
Other outcomes:
Locations:
city: Jyväskylä
country: Finland
facility: Central Hospital Jyväskylä
city: Oulu
country: Finland
facility: Oulu Unversity Hospital
city: Seinäjoki
country: Finland
facility: Seinäjoki Central Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: University of Oulu
name: Marjo Renko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: