None listed
Conditions
Brief summary
The primary purpose of the study is to test the efficacy of HFNP WHO compared to standard oxygen therapy (cold low flow) in the treatment of acute moderate bronchiolitis using time to event data (time to oxygen weaning) as the primary outcome. Three supporting safety outcomes and several exploratory outcomes are included in this single site clinical trial.
Interventions
High-flow, nasal prong, warmed, humidified oxygen delivered via the Fisher & Paykel MR850 with Optiflow Junior(TM) nasal prongs (max. 1.0 L/kg/min; 1:1 air:O2 flow ratio) to a maximum flow rate of 20L/min. Supplemental oxygen will be administered for as long as is clinically necessary to support oxygen saturations greater than or equal to 95% during the admission. Participants on both the intervention and control arms will have the option of participating in the nested longitudinal observational
High-flow, nasal prong, warmed, humidified oxygen delivered via the Fisher & Paykel MR850 with Optiflow Junior(TM) nasal prongs (max. 1.0 L/kg/min; 1:1 air:O2 flow ratio) to a maximum flow rate of 20L/min. Supplemental oxygen will be administered for as long as is clinically necessary to support oxygen saturations greater than or equal to 95% during the admission. Participants on both the intervention and control arms will have the option of participating in the nested longitudinal observational study of Infant Lung Function (09/07/15/5.04 HREC/09/HNE/242) which involves follow-up infant lung function tests and assessments at 1 month and 12 months post-discharge.
Sponsors
John Hunter Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
1 Days to 24 Months
Healthy volunteers
No
Inclusion criteria
Consented infants aged less than or equal to 24 months with a clinical diagnosis of moderate bronchiolitis presenting to the ED or Medical Unit . Infants on home oxygen may be included in this study, with weaning aimed to home oxygen rate rather than room air in these cases.
Exclusion criteria
Infants with mild bronchiolitis not requiring oxygen (but may be enrolled if the infant’s condition deteriorates and O2 is required after admission). Those with severe/life-threatening bronchiolitis (as defined by NSW Health, PD 2012_004 Infants and Children - Acute Management of Bronchiolitis) Infants admitted to ward following ICU management of bronchiolitis. Infants transferred from other facilities if they have received supplemental oxygen for bronchiolitis prior to arrival. Infants nursed in other wards due to lack of beds in the medical ward. Infants on prior asthma prevention or treatment medication. Infants with pneumothorax and/or nasal trauma
Outcome results
None listed