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BMJ Open. 2019 Dec 18;9(12):e030516. doi: 10.1136/bmjopen-2019-030516.

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).

Franklin D1,2,3,4, Shellshear D4,5,6, Babl FE4,7,8,9, Schlapbach LJ10,2,6, Oakley E4,7,8,9, Borland ML4,11,12, Hoeppner T4,11, George S10,2,4,13, Craig S4,14,15, Neutze J4,16,17, Williams A4,7,8, Acworth J2,4,5, McCay H18, Wallace A18, Mattes J19,20, Gangathimn V4,21, Wildman M4,21, Fraser JF22,23, Moloney S24, Gavranich J25, Waugh J26, Hobbins S27, Fahy R27, Grew S28, Gannon B29, Gibbons K10,3, Dalziel S4,17,30,31, Schibler A10,2,3,4,6; PARIS and PREDICT.

Author information

1
Paediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia d.franklin2@uq.edu.au.
2
School of Medicine, The University Of Queensland, St Lucia, Queensland, Australia.
3
Mater Medical Research Institute, South Brisbane, Queensland, Australia.
4
Paediatric Research in Emergency Departments International Collaborative (PREDICT), Parkville, Victoria, Australia.
5
Emergency Department, Queensland Children's Hospital, South Brisbane, Queensland, Australia.
6
Queensland Children's Hospital, South Brisbane, Queensland, Australia.
7
Emergency Department, Royal Childrens Hospital, Parkville, Victoria, Australia.
8
Murdoch Children's Research Institute, Melbourne, Victoria, Australia.
9
Department of Paediatrics, Faculty of Medicine, Dentistry and Health Services, University of Melbourne, Melbourne, Victoria, Australia.
10
Paediatric Critical Care Research Group, Child Health Research Centre, The University of Queensland, Brisbane, Queensland, Australia.
11
Emergency, Princess Margaret Hospital for Children, Subiaco, Western Australia, Australia.
12
University of Western Australia, School of Medicine, Divisions of Emergency Medicine and Paediatrics, Crawley, Western Australia, Australia.
13
Emergency Department, Gold Coast University Hospital, Southport, Queensland, Australia.
14
Emergency Department, Monash Medical Centre Clayton, Clayton, Victoria, Australia.
15
Department of Medicine, School of Clinical Science, Monash University, Clayton, Victoria, Australia.
16
KidzFirst Middlemore Emergency Department, Middlemore Hospital, Auckland, New Zealand.
17
University of Auckland, Auckland, New Zealand.
18
Paediatrics, Waikato Hospital, Hamilton, New Zealand.
19
Paediatrics, John Hunter Children's Hospital, Hunter Region Mail Centre, New South Wales, Australia.
20
University of Newcastle, Priority Research Centre GrowUpWell, Callaghan, New South Wales, Australia.
21
Emergency Department, Townsville General Hospital, Townsville, Queensland, Australia.
22
Adult Intensive Care Services, The Prince Charles Hospital, Brisbane, Queensland, Australia.
23
Critical Care Research Group, The Prince Charles Hospital and University of Queensland, Brisbane, Queensland, Australia.
24
Paediatric Department, Gold Coast University Hospital, Southport, Queensland, Australia.
25
Paediatrics, Ipswich Hospital, Ipswich, Queensland, Australia.
26
Paediatrics, Caboolture Hospital, Caboolture, Queensland, Australia.
27
Paediatrics, Prince Charles Hospital, Chermside, Queensland, Australia.
28
Paediatrics, Redcliffe Hospital, Redcliffe, Queensland, Australia.
29
The University of Queensland, Centre for Business and Economics of Health, St Lucia Qld, Queensland, Australia.
30
Starship Children's Health, Emergency Department, Newmarket, New Zealand.
31
Department of Surgery and Paediatrics, Child and Youth Health, University of Auckland, Auckland, New Zealand.

Abstract

INTRODUCTION:

Acute hypoxaemic respiratory failure (AHRF) in children is the most frequent reason for non-elective hospital admission. During the initial phase, AHRF is a clinical syndrome defined for the purpose of this study by an oxygen requirement and caused by pneumonia, lower respiratory tract infections, asthma or bronchiolitis. Up to 20% of these children with AHRF can rapidly deteriorate requiring non-invasive or invasive ventilation. Nasal high-flow (NHF) therapy has been used by clinicians for oxygen therapy outside intensive care settings to prevent escalation of care. A recent randomised trial in infants with bronchiolitis has shown that NHF therapy reduces the need to escalate therapy. No similar data is available in the older children presenting with AHRF. In this study we aim to investigate in children aged 1 to 4 years presenting with AHRF if early NHF therapy compared with standard-oxygen therapy reduces hospital length of stay and if this is cost-effective compared with standard treatment.

METHODS AND ANALYSIS:

The study design is an open-labelled randomised multicentre trial comparing early NHF and standard-oxygen therapy and will be stratified by sites and into obstructive and non-obstructive groups. Children aged 1 to 4 years (n=1512) presenting with AHRF to one of the participating emergency departments will be randomly allocated to NHF or standard-oxygen therapy once the eligibility criteria have been met (oxygen requirement with transcutaneous saturation <92%/90% (dependant on hospital standard threshold), diagnosis of AHRF, admission to hospital and tachypnoea ≥35 breaths/min). Children in the standard-oxygen group can receive rescue NHF therapy if escalation is required. The primary outcome is hospital length of stay. Secondary outcomes will include length of oxygen therapy, proportion of intensive care admissions, healthcare resource utilisation and associated costs. Analyses will be conducted on an intention-to-treat basis.

ETHICS AND DISSEMINATION:

Ethics approval has been obtained in Australia (HREC/15/QRCH/159) and New Zealand (HDEC 17/NTA/135). The trial commenced recruitment in December 2017. The study findings will be submitted for publication in a peer-reviewed journal and presented at relevant conferences. Authorship of all publications will be decided by mutual consensus of the research team.

TRIAL REGISTRATION NUMBER:

ACTRN12618000210279.

KEYWORDS:

children; oxygen therapy; paediatric; respiratory disease; respiratory support

Conflict of interest statement

Competing interests: DF, SG, AS and SD received travel support from Fisher and Paykel Healthcare. All other authors have no conflicts to disclose. Fisher and Paykel have provided equipment and consumables for the study but have had no input in the study design.

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