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BMC Pediatr. 2015 Nov 14;15:183. doi: 10.1186/s12887-015-0501-x.

Early high flow nasal cannula therapy in bronchiolitis, a prospective randomised control trial (protocol): A Paediatric Acute Respiratory Intervention Study (PARIS).

Franklin D1,2,3,4, Dalziel S5,6,7, Schlapbach LJ8,9,10,11, Babl FE12,13,14,15, Oakley E12,13,14,15, Craig SS13,16,17,15, Furyk JS18,19,15, Neutze J7,20,15, Sinn K21,22,15, Whitty JA23, Gibbons K8,10, Fraser J9,24, Schibler A8,9,10; PARIS and PREDICT.

Author information

1
Paediatric Critical Care Research Group, Lady Cilento Children's Hospital and The University of Queensland, Brisbane, Australia. d.franklin2@uq.edu.au.
2
The University of Queensland, School of Medicine, Brisbane, Australia. d.franklin2@uq.edu.au.
3
Mater Research Institution The University of Queensland, Brisbane, Australia. d.franklin2@uq.edu.au.
4
Paediatric Intensive Care Unit, Paediatric Critical Care Research Group (PCCRG), Lady Cilento Children's Hospital and The University of Queensland, 501 Stanley St, South, Brisbane, Queensland, 4101, Australia. d.franklin2@uq.edu.au.
5
Starship Children's Hospital, Auckland, New Zealand.
6
Liggins Institute, University of Auckland, Auckland, New Zealand.
7
KidzFirst Middlemore Hospital, Auckland, New Zealand.
8
Paediatric Critical Care Research Group, Lady Cilento Children's Hospital and The University of Queensland, Brisbane, Australia.
9
The University of Queensland, School of Medicine, Brisbane, Australia.
10
Mater Research Institution The University of Queensland, Brisbane, Australia.
11
Department of Pediatrics, Inselspital, University of Bern, Bern, Switzerland.
12
Emergency Department, Royal Children's Hospital, Melbourne, Australia.
13
Murdoch Children's Research Institute Melbourne, Melbourne, Australia.
14
University of Melbourne, Melbourne, Australia.
15
Paediatric Research in Emergency Departments International Collaborative (PREDICT), Brisbane, Australia.
16
Emergency Department, Monash Children's Hospital, Melbourne, Australia.
17
Monash University, Melbourne, Australia.
18
Emergency Department, The Townsville Hospital, Townsville, Australia.
19
James Cook University, Townsville, Australia.
20
University of Auckland, Auckland, New Zealand.
21
Emergency Department, The Canberra Hospital, Canberra, Australia.
22
Australian National University, Canberra, Australia.
23
School of Pharmacy, Faculty of Health and Behavioural Sciences, The University of Queensland, Brisbane, Australia.
24
Critical Care Research Group, The Prince Charles Hospital, Brisbane, Australia.

Abstract

BACKGROUND:

Bronchiolitis imposes the largest health care burden on non-elective paediatric hospital admissions worldwide, with up to 15 % of cases requiring admission to intensive care. A number of previous studies have failed to show benefit of pharmaceutical treatment in respect to length of stay, reduction in PICU admission rates or intubation frequency. The early use of non-invasive respiratory support devices in less intensive scenarios to facilitate earlier respiratory support may have an impact on outcome by avoiding progression of the disease process. High Flow Nasal Cannula (HFNC) therapy has emerged as a new method to provide humidified air flow to deliver a non-invasive form of positive pressure support with titratable oxygen fraction. There is a lack of high-grade evidence on use of HFNC therapy in bronchiolitis.

METHODS/DESIGN:

Prospective multi-centre randomised trial comparing standard treatment (standard subnasal oxygen) and High Flow Nasal Cannula therapy in infants with bronchiolitis admitted to 17 hospitals emergency departments and wards in Australia and New Zealand, including 12 non-tertiary regional/metropolitan and 5 tertiary centres. The primary outcome is treatment failure; defined as meeting three out of four pre-specified failure criteria requiring escalation of treatment or higher level of care; i) heart rate remains unchanged or increased compared to admission/enrolment observations, ii) respiratory rate remains unchanged or increased compared to admission/enrolment observations, iii) oxygen requirement in HFNC therapy arm exceeds FiO2 ≥ 40 % to maintain SpO2 ≥ 92 % (or ≥94 %) or oxygen requirement in standard subnasal oxygen therapy arm exceeds >2L/min to maintain SpO2 ≥ 92 % (or ≥94 %), and iv) hospital internal Early Warning Tool calls for medical review and escalation of care. Secondary outcomes include transfer to tertiary institution, admission to intensive care, length of stay, length of oxygen treatment, need for non-invasive/invasive ventilation, intubation, adverse events, and cost.

DISCUSSION:

This large multicenter randomised trial will allow the definitive assessment of the efficacy of HFNC therapy as compared to standard subnasal oxygen in the treatment of bronchiolitis.

TRIAL REGISTRATION:

The trial is registered with the Australian and New Zealand Clinical Trials Registry ACTRN12613000388718 (registered on 10 April 2013).

PMID:
26572729
PMCID:
PMC4647636
DOI:
10.1186/s12887-015-0501-x
[Indexed for MEDLINE]
Free PMC Article

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