ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12613000388718

Ethics application status

Approved

Date submitted

3/04/2013

Date registered

10/04/2013

Date last updated

4/03/2020

Date data sharing statement initially provided

4/03/2020

Date results provided

4/03/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Viral bronchiolitis

Condition category

Condition code

Respiratory

Other respiratory disorders / diseases

Infection

Other infectious diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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

Intervention code [1]

Treatment: Devices

Comparator / control treatment

standard oxygen delivery via face mask or subnasal oxygen with a maximal rate of 2L/min

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome is the proportion of infants in each group with treatment failure. Treatment failure of either standard subnasal oxygen or HFNC therapy arm is defined as meeting three out of four specified failure criteria receiving escalation of treatment or higher level of care such as high acuity or intensive care. Treatment failure of either standard subnasal oxygen or HFNC therapy arm is defined if three of the four following criteria are met and an escalation of treatment or level of care is required

a.) heart rate remains unchanged or increased compared to admission/enrollment observations,
b.) respiratory rate remains unchanged or increased compared to admission/enrollment observations,
c.) oxygen requirement in HFNC therapy arm exceeds FiO2 greater than 40% to maintain SpO2 greater than or equal to 92% (or greater than or equal to 94%) or oxygen requirement in standard subnasal oxygen therapy arm exceeds >2L/min to maintain SpO2 greater than or equal to 92% (or greater than or equal to 94%)
d.) hospital internal Early Warning Tool calls for medical review and escalation of care.

Timepoint [1]

During Hospital Admission

Secondary outcome [1]

Reduction in Intubation Rate

Timepoint [1]

During Hospital Admission

Secondary outcome [2]

Length of Stay in Hospital

Timepoint [2]

During Admission

Eligibility

Key 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.

Minimum age

0 Months

Maximum age

12 Months

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

craniofacial malformation
impending intubation

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Randomisation on ED admission using central online randomisation allocation concealment

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

equal random sample per hospital site using a permuated block randomisation

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

In 2011 there were 478 eligible patients admitted to 4 of 8 pilot hospitals (Queensland), of which 80 required transfer to a tertiary paediatric centre (16.7 %). Assuming a conservative baseline rate of failure of standard therapy (need for transfer to a specialist paediatric centre or PICU admission) of 10 %, a 50 % relative reduction to 5 % with a power of 90 % and type I error of 0.05, 582 participants per group are required, resulting in a total sample size of 1164 patients. An attrition rate of approximately 10-20 % is estimated, which gives an overall sample size of 1400.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

1/07/2013

Actual

4/11/2013

Date of last participant enrolment

Anticipated

31/12/2017

Actual

15/08/2016

Date of last data collection

Anticipated

31/12/2023

Actual

Sample size

Target

1400

Accrual to date

Final

1472

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,VIC

Recruitment hospital [1]

The Tweed Hospital - Tweed Heads

Recruitment hospital [2]

Gold Coast Hospital - Southport

Recruitment hospital [3]

Logan Hospital - Meadowbrook

Recruitment hospital [4]

Ipswich Hospital - Ipswich

Recruitment hospital [5]

Toowoomba Hospital - Toowoomba

Recruitment hospital [6]

Redcliffe Hospital - Redcliffe

Recruitment hospital [7]

Redland Hospital - Cleveland

Recruitment hospital [8]

Nambour General Hospital - Nambour

Recruitment hospital [9]

Redland Hospital - Cleveland

Recruitment hospital [10]

Caboolture Hospital - Caboolture

Recruitment hospital [11]

Lady Cilento Children's Hospital - South Brisbane

Recruitment hospital [12]

The Royal Childrens Hospital - Parkville

Recruitment hospital [13]

The Canberra Hospital - Garran

Recruitment hospital [14]

The Townsville Hospital - Douglas

Recruitment hospital [15]

Monash Medical Centre - Clayton campus - Clayton

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC

Address [1]

Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Queensland Emergency Medical Research Fund

Address [2]

2/15 Lang Parade, Milton Qld 4064

Country [2]

Australia

Primary sponsor type

Individual

Name

Andreas Schibler

Address

Lady Cilento Children's Hospital
Stanley Street 501
South Brisbane 4101
Queensland, Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children's Health Service Human Research Ethics Committee

Ethics committee address [1]

Level 7, Centre for Children’s Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane  QLD  4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/04/2013

Approval date [1]

20/06/2013

Ethics approval number [1]

ECO00175

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Andreas Schibler

Address

Lady Cilento Children's Hospital, Stanley Street, South Brisbane 4101 QLD Australia

Country

Australia

Phone

+61(0)730681111

Fax

[email protected]

Contact person for public queries

Name

Donna Franklin

Address

Queensland Children's Hospital (formerly Lady Cilento Children's Hospital)
Level 7
62 Graham Street
South Brisbane Qld 4101

Country

Australia

Phone

+61 7 3069 7000

Fax

[email protected]

Contact person for scientific queries

Name

Andreas Schibler

Address

Queensland Children's Hospital (formerly Lady Cilento Children's Hospital)
Level 7
62 Graham Street
South Brisbane Qld 4101

Country

Australia

Phone

+61 7 30697000

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

All relevant data sharing is already published with the main outcome paper. See below itemised components.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
7232	Study protocol	Franklin, D., et al. Early high flow nasal cannula therapy in bronchiolitis, a prospective randomised control trial (protocol): A Paediatric Acute Respiratory Intervention Study (PARIS). BMC Pediatr, 2015; 15(1): p.183.
7234	Statistical analysis plan	Franklin, D. et al., High-flow Therapy for Infants with Bronchiolitis – A Randomized Trial. N Engl J Med., 2018; 378: 1121-1131.	https://link.springer.com/article/10.1186/s12887-015-0501-x		The Statistical analysis plan can be located with ... [More Details]	363970-(Uploaded-03-03-2020-11-04-39)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Early high flow nasal cannula therapy in bronchiolitis, a prospective randomised control trial (protocol): A Paediatric Acute Respiratory Intervention Study (PARIS).	2015	https://dx.doi.org/10.1186/s12887-015-0501-x
Dimensions AI	Easing the wheeze	2015	https://doi.org/10.1111/1742-6723.12463
Dimensions AI	A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis	2018	https://doi.org/10.1056/nejmoa1714855
Embase	Enteral hydration in high-flow therapy for infants with bronchiolitis: Secondary analysis of a randomised trial.	2020	https://dx.doi.org/10.1111/jpc.14799
Embase	First-line oxygen therapy with high-flow in bronchiolitis is not cost saving for the health service.	2020	https://dx.doi.org/10.1136/archdischild-2019-318427

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically