High Flow Nasal Cannula RCT

PARIS 1

Bronchiolitis, a viral lung disease in infants, is the most common reason worldwide for infants <1 year of age to be admitted into hospital, with approximately 9000 admissions occurring annually in Australia alone.    Over the last decade a new method to provide respiratory support to infants <1 year of age with bronchiolitis has emerged, high flow nasal cannula (HFNC). Non-experimental evidence, from our group, has shown that HFNC in bronchiolitis can be applied very early in the disease process, can be provided on paediatric wards (both regional and tertiary centres), reduces the need for PICU admission, and reduces the need for non-invasive and invasive ventilation once in PICU. However, the majority of this evidence has focused on critically ill infants with bronchiolitis, the role of HFNC in moderately unwell hospitalised infants with bronchiolitis, the majority of infants hospitalised with bronchiolitis, has yet to be defined. We will perform a large multi-centre randomised trial comparing respiratory support and oxygen delivery via HFNC with respiratory support and oxygen delivery via standard nasal cannula in infants admitted to hospitals with bronchiolitis, in Australia and New Zealand, to determine which treatment strategy results in less clinical deterioration. In addition, we will assess the health care cost of the two treatment strategies.

Study design

Open label, multi-centre, randomised controlled trial

Completed

Respiratory

Andreas Schibler

Time frame

2015 – 2018

Funding

  • National Health and Medical Research Council (project)
  • Emergency Medicine Foundation
  • Townsville Hospital Foundation
  • Murdoch Children’s Research Institute
  • Ipswich Hospital Foundation
  • Gold Coast Hospital Foundation

  • Ipswich Hospital, Queensland, Australia
  • Caboolture Hospital, Queensland, Australia
  • Redland Hospital, Queensland, Australia
  • Redcliffe Hospital, Queensland, Australia
  • The Prince Charles Hospital, Queensland, Australia
  • Gold Coast University Hospital, Brisbane, Australia
  • Toowoomba Hospital, Queensland, Australia
  • Logan Hospital, Queensland, Australia
  • Nambour Hospital, Queensland, Australia
  • Lady Cilento Children’s Hospital, South Brisbane, Queensland, Australia
  • Townsville Hospital, Queensland, Australia.
  • The Tweed Hospital, Tweed Heads, New South Wales, Australia
  • Royal Children’s Hospital, Melbourne, Australia
  • Monash Children’s Hospital, Victoria, Australia
  • The Canberra Hospital, ACT, Australia
  • Starship Children’s Hospital, Auckland, New Zealand
  • KidzFirst Middlemore Hospital, Auckland, New Zealand

Sample

1400 infants 0 – 12 months with bronchiolitis (700 per group)

Contact

a.schibler@uq.edu.au

Publications to date

Franklin D, Babl FE, Neutze J, Craig S, Oakley E, Furyk J, Frampton CM, Hasan N, Pham TM, Miller L, Fraser JF, Dalziel SR, Schibler A; A Pediatric Acute Respiratory Intervention Study (PARIS) on behalf of PREDICT. Predictors of Intensive Care Admission in Hypoxemic Bronchiolitis Infants, Secondary Analysis of a Randomized Trial. J Pediatr. 2023 May;256:92-97.e1. doi: 10.1016/j.jpeds.2022.12.006. Epub 2022 Dec 14. PMID: 36528052. [Link]

Franklin D, Schibler A. Rising Intensive Care Costs in Bronchiolitis Infants-Is Nasal High Flow the Culprit? Pediatr Crit Care Med. 2022 Mar 1;23(3):218-222. doi: 10.1097/PCC.0000000000002900. PMID: 35238842. [Link]

Gc VS, Franklin D, Whitty JA, Dalziel SR, Babl FE, Schlapbach LJ, Fraser JF, Craig S, Neutze J, Oakley E, Schibler A. First-line oxygen therapy with high-flow in bronchiolitis is not cost saving for the health service. Arch Dis Child. 2020 Oct;105(10):975-980. doi: 10.1136/archdischild-2019-318427. Epub 2020 Apr 10. PMID: 32276987. [link]

Babl FE, Franklin D, Dalziel S, Schibler A; Paediatric Research in Emergency Departments International Collaborative and Pediatric Critical Care Research Group. Enteral hydration in high flow therapy. J Paediatr Child Health. 2020 Jun;56(6):989. doi: 10.1111/jpc.14894. PMID: 32567779. [link].

Babl FE, Franklin D, Schlapbach LJ, Oakley E, Dalziel S, Whitty JA, Neutze J, Furyk J, Craig S, Fraser JF, Jones M, Schibler A; PREDICT and Pediatric Critical Care Research Group. Enteral hydration in high-flow therapy for infants with bronchiolitis: Secondary analysis of a randomised trial. J Paediatr Child Health. 2020 Jun;56(6):950-955. doi: 10.1111/jpc.14799. Epub 2020 Feb 11. PMID: 32043304. [link]

Franklin D, Babl FE, Schlapbach LJ, Oakley E, Craig S, Neutze J, Furyk J, Fraser JF, Jones M, Whitty JA, Dalziel SR, Schibler A.  A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis. N Engl J Med. 2018 Mar 22;378(12):1121-1131. doi: 10.1056/NEJMoa1714855. PMID: 29562151. [link]

Franklin D, Babl FE, Gibbons K, Pham TMT, Hasan N, Schlapbach LJ, Oakley E, Craig S, Furyk J, Neutze J, Moloney S, Gavranich J, Shirkhedkar P, Kapoor V, Grew S, Fraser JF, Dalziel S, Schibler A; PARIS and PREDICT.  Nasal High Flow in Room Air for Hypoxemic Bronchiolitis Infants. Front Pediatr. 2019 Oct 25;7:426. doi: 10.3389/fped.2019.00426. PMID: 31709201; PMCID: PMC6823186. [link]

Franklin D, Dalziel S, Schlapbach LJ, Babl FE, Oakley E, Craig SS, Furyk JS, Neutze J, Sinn K, Whitty JA, Gibbons K, Fraser J, Schibler A; PARIS and PREDICT. Early high flow nasal cannula therapy in bronchiolitis, a prospective randomised control trial (protocol): A Paediatric Acute Respiratory Intervention Study (PARIS). BMC Pediatr. 2015 Nov 14;15:183. doi: 10.1186/s12887-015-0501-x. PMID: 26572729. [link]