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High Flow Nasal Cannula Treatment for Viral Bronchiolitis in Infants, a Randomised Controlled Trial

High Flow Nasal Cannula Treatment for Viral Bronchiolitis in Infants, a Randomised Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000388718
Enrollment
1472
Registered
2013-04-10
Start date
2013-11-04
Completion date
2016-08-15
Last updated
2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Bronchiolitis is the leading cause of paediatric hospitalisation in Australia accounting for approximately 8000 admissions annually, of which approximately 500-600 are admitted to a paediatric intensive care unit (PICU) requiring respiratory support. There have been numerous attempts and studies over the last three decades investigating the roles of steroids, salbutamol, adrenalin and inhalation of hypertonic saline in infants with bronchiolitis. None have successfully changed the outcome of the disease or the burden on health care systems. High flow nasal cannula (HFNC) therapy has been used over the last 8 years in paediatrics with reports showing a reduction in the need for non-invasive and invasive ventilation. HFNC reduces the work of breathing, improves the gas exchange and can be applied very early in the disease process as there is little interference with the patients comfort. Despite the existing data, the uptake of HFNC therapy in paediatrics is sporadic. This is, in part, due to a lack of “best practice”. Similarly, many centres do not use the HFNC for bronchiolitis as there are opposing report about its benefit and a lack of consensus on how to use it. This study aims to develop a multi-centre trial and to assess which patients with bronchiolitis benefit using HFNC. For this purpose we will perform a randomised controlled trial comparing current best practice versus HFNC therapy. With the introduction of this simple to use respiratory system in regional hospitals we aim to reduce the need to transfer infants with bronchiolitis to tertiary centres.

Interventions

High Flow Nasal Cannula Oxygen Delivery at a rate of 2L/kg/min for the duration of oxygen requirement

Sponsors

Andreas Schibler
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 12 Months
Healthy volunteers
No

Inclusion criteria

Inclusion criteria are infants with a clinical diagnosis of bronchiolitis less than 12 months corrected age (greater than or equal to 37 weeks post-conceptional age) with an oxygen requirement in room air of SpO2 < 92% for tertiary centres and <94% for regional and metropolitan centres.

Exclusion criteria

craniofacial malformation impending intubation

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 3, 2026