PARIS 2

Nasal High Flow Therapy for Infants and Children with Acute Hypoxemic Respiratory Failure – a Randomised Controlled Trial

This study aims to conduct a multi-centre trial to assess which infants and children with acute hypoxemic respiratory failure (AHRF) benefit from using Nasal High Flow (NHF) Therapy. For this purpose we will perform a randomised controlled trial comparing current best practice (standard oxygen delivery via subnasal prongs, facemask, venturi mask) versus NHF therapy in children aged 1 – 4 years. With the introduction of this simple to use respiratory system in regional and tertiary centres we aim to investigate if NHF therapy has a lower treatment failure rate in comparison to standard oxygen delivery, and to investigate if there is a reduction in the need for transfer of these patients the intensive care unit.

Study design

A phase III randomised controlled trial

Completed

Respiratory

A/Prof Andreas Schibler (Queensland Children’s Hospital)

Timeframe

2017 – 2021

Funding

Thrasher Research Funds
National Health and Medical Research Council (ID:1123663)
Children’s Health Foundation (LCCH),
Emergency Medicine Foundation


  • Lady Cilento Children’s Hospital, Brisbane, QLD, Australia
  • Royal Children’s Hospital, Melbourne, Australia
  • Gold Coast Hospital, Southport, Queensland, Australia.
  • Starship Children’s Hospital, Auckland, New Zealand
  • KidzFirst Middlemore Hospital, Auckland, New Zealand
  • Redcliffe Hospital, Redcliffe, QLD, Australia
  • Prince Charles Hospital, Chermside, QLD, Australia
  • Sunshine Coast University Hospital, Sunshine Coast, QLD, Australia
  • Logan Hospital, Logan, QLD, Australia
  • Ipswich Hospital, Ipswich, QLD, Australia
  • Redland Hospital, Cleveland, QLD, Australia
  • Toowoomba Hospital, Toowoomba, QLD, Australia
  • The Tweed hospital, Tweed Heads, NSW, Australia
  • Monash Children’s Hospital, Clayton, VIC, Australia
  • Townsville Hospital, Townsville, Queensland, Australia
  • The Children’s Hospital at Westmead, Sydney, NSW, Australia
  • Caboolture Hospital, Caboolture, QLD, Australia
  • Perth Children’s Hospital, Perth, WA,  Australia
  • John Hunter Hospital, Newcastle, NSW, Australia

Sample

1634 children aged 1 – 4 years + 364 days with AHRF

Clinical trial registrations

Click here

Contact

a.schibler@uq.edu.au

Publications to date

Franklin D, Shellshear D, Babl FE, Hendrickson R, Williams A, Gibbons K, McEnery K, Kennedy M, Pham TM, Acworth J, Levitt D, Oakley E, Schibler A; PARIS and PREDICT.  High flow in children with respiratory failure: A randomised controlled pilot trial – A paediatric acute respiratory intervention study. J Paediatr Child Health. 2021 Feb;57(2):273-281. doi: 10.1111/jpc.15259. Epub 2020 Dec 30. PMID: 33377568. [link]

Franklin D, Shellshear D, Babl FE, Schlapbach LJ, Oakley E, Borland ML, Hoeppner T, George S, Craig S, Neutze J, Williams A, Acworth J, McCay H, Wallace A, Mattes J, Gangathimn V, Wildman M, Fraser JF, Moloney S, Gavranich J, Waugh J, Hobbins S, Fahy R, Grew S, Gannon B, Gibbons K, Dalziel S, Schibler A; PARIS and PREDICT. Multicentre, randomised trial to investigate early nasal high-flow therapy in paediatric acute hypoxaemic respiratory failure: a protocol for a randomised controlled trial-a Paediatric Acute respiratory Intervention Study (PARIS 2). BMJ Open. 2019 Dec 18;9(12):e030516. doi: 10.1136/bmjopen-2019-030516. PMID: 31857300; PMCID: PMC6937038. [link]