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Trial registered on ANZCTR
Registration number
ACTRN12612000685819
Ethics application status
Approved
Date submitted
26/06/2012
Date registered
26/06/2012
Date last updated
8/07/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Randomised control trial of high-flow nasal prong warm, humidified oxygen (HFNP WHO) compared to standard oxygen therapy in the management of moderate bronchiolitis in infants aged less than or equal to 24 months in the Emergency Department (ED) and Children's Medical Ward of a tertiary referral hospital.
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Scientific title
A single site, open, two arm, randomised control trial (RCT), with nested longitudinal observational study, of infants aged less than or equal to 24 months with moderate bronchiolitis to test the effect of high-flow nasal prong warm, humidified oxygen (HFNP WHO) (1L/kg/min total flow with 1:1 air:O2 ratio to a maximum of 20L/min or FiO2 60%) compared to standard nasal prong cold humidified oxygen (2.0L/min maximum flow) on median time to weaning off supplemental oxygen during the acute admission.
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Secondary ID [1]
280381
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N/A
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Universal Trial Number (UTN)
U1111-1130-1651
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Trial acronym
HFNP WHO RCT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute moderate bronchiolitis
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Condition category
Condition code
Respiratory
286598
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0
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Other respiratory disorders / diseases
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Infection
286600
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0
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Studies of infection and infectious agents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
High-flow, nasal prong, warmed, humidified oxygen delivered via the Fisher & Paykel MR850 with Optiflow Junior(TM) nasal prongs (max. 1.0 L/kg/min; 1:1 air:O2 flow ratio) to a maximum flow rate of 20L/min. Supplemental oxygen will be administered for as long as is clinically necessary to support oxygen saturations greater than or equal to 95% during the admission. Participants on both the intervention and control arms will have the option of participating in the nested longitudinal observational study of Infant Lung Function (09/07/15/5.04 HREC/09/HNE/242) which involves follow-up infant lung function tests and assessments at 1 month and 12 months post-discharge.
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Intervention code [1]
284744
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Treatment: Devices
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
The enrolled infants will move through the ED and Children's Medical Ward allocated to either the experimental treatment or control standard treatment. No humidification with cold low-flow oxygen (max. 2.0 L/min) is standard care in the ED during the acute admission process.
Cold low-flow nasal prong oxygen (max. 2.0 L/min) with an AquaPak humidifier (Hudson RCI, USA) is standard care instituted at the time of admission to the Children's Medical Ward.
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Control group
Active
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Outcomes
Primary outcome [1]
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Median time to weaning off supplemental oxygen (hours) following defined weaning criteria based on NSW Health Standard Paediatric Observation Charts and full explained in a standard operating procedure. Weaning of oxygen is successful if the infant remains stable in room air for 6 hours or until discharge, whichever is less.
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Assessment method [1]
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Timepoint [1]
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Hours from randomisation to successful weaning to room air (or pre-morbid home-oxygen rate) with treatment failure care included in cases where failure has occurred.
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Secondary outcome [1]
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Proportion and rate of treatment failure. Treatment failure is a clinical judgement based on documented observations, clinical examination, and the clinical decision that a change in treatment is required to prevent further deterioration.
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Assessment method [1]
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Timepoint [1]
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Measured at two time points: from randomisation to leaving ED; and from randomisation to successful weaning to room air.
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Secondary outcome [2]
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Mean change from baseline in heart rate, respsiratory rate, and respiratory distress score as recorded hourly on NSW Health Standard Paediatric Observation Charts. .
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Assessment method [2]
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Timepoint [2]
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Calculated for ED from observations at baseline and 4 hours (or pre-transfer to ward whichever is less);
and in ward from observations at baseline and 24 hours from standard hourly observations on NSW Health Standard Paediatric Observation Charts.
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Secondary outcome [3]
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Mean length of stay (LOS) as determined by medical records discharge data.
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Assessment method [3]
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Timepoint [3]
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Days from admission to discharge.
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Secondary outcome [4]
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Proportion of harms (Adverse events). Adverse events (AEs) will be recorded on the Incident Information Management System (IIMS) and will be rated 1-2 for serious AEs and 3-4 for AEs. The control arm participants may experience decreased feeding due to the irritation of cold gas in the nose; drier thicker sectretions requiring mechanincal suction; and mucousal bleeding. The experimental arm participants may experience decreased feeding from higher flows of gas in the nose; and there is a risk of condensed vapour in the humidifier circuit running back into the nares if the circuit is raised above the level of the infant's nose. A follow-up phone survey will be attended at 30 days post-discharge to surveil for AEs identified by the parent/guardian post-discharge.
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Assessment method [4]
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Timepoint [4]
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From recruitment to 30 days post-discharge from acute admission.
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Secondary outcome [5]
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Mean change in severity score using Modified Woods Clinical Asthma Score (M-WCAS). Results will be correlated to the severity rating of NSW Health Standard Paediatric Observation Charts.
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Assessment method [5]
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Timepoint [5]
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Measured at baseline and at 4 hours or time of transfer from ED, whichever is less;
and at baseline and daily in the ward.
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Secondary outcome [6]
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Mean scores of parent assessment of quality of feeding, sleep/rest, and safety obtained from a structured eight question phone survey administered 30 days post-discharge.
Proportion of post-discharge medical presentations for related events e.g. re-presentations with bronchiolitis, pneumonia, or potential parent reported adverse events such as pressure areas on the face, ears, head; nose bleeds.
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Assessment method [6]
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Timepoint [6]
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30 days post-discharge.
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Secondary outcome [7]
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Biomarker - association between causative organism and severity with organism if identified by Multiplex 10 Polymerase Chain Reaction (PCR).
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Assessment method [7]
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Timepoint [7]
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Nasopharyngeal aspirate collected within 24 hours of admission.
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Secondary outcome [8]
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Biomarker - Immune response to virus. Blood examined for anti-viral response.
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Assessment method [8]
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Timepoint [8]
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Blood collected at the time of cannulation if the infant requires a cannula as standard clinical care.
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Secondary outcome [9]
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Diagnostic - Accuracy of lung ultrasound to detect lung abnormalities as compared to clinical findings across groups, and compared to available chest xray (CXR) results if attended in individual cases as part of standard clinical care.
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Assessment method [9]
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Timepoint [9]
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One at baseline (day 1), and then one or more on day two from recruitment, in the event of treatment failure, and before discharge.
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Eligibility
Key inclusion criteria
Consented infants aged less than or equal to 24 months with a clinical diagnosis of moderate bronchiolitis presenting to the ED or Medical Unit . Infants on home oxygen may be included in this study, with weaning aimed to home oxygen rate rather than room air in these cases.
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Minimum age
1
Days
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Maximum age
24
Months
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Infants with mild bronchiolitis not requiring oxygen (but may be enrolled if the infant’s condition deteriorates and O2 is required after admission).
Those with severe/life-threatening bronchiolitis (as defined by NSW Health, PD 2012_004 Infants and Children - Acute Management of Bronchiolitis)
Infants admitted to ward following ICU management of bronchiolitis.
Infants transferred from other facilities if they have received supplemental oxygen for bronchiolitis prior to arrival.
Infants nursed in other wards due to lack of beds in the medical ward.
Infants on prior asthma prevention or treatment medication.
Infants with pneumothorax and/or nasal trauma
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Stratification by defined gestational history (Extreme prem; Prem; Term) is used to control for this covariate.
Consecutive, enrolled participants will be assigned to treatment according to the child's gestational history (stratification - 3 levels) and the allocation will be concealed in the next sequential privacy envelope available for the required stratification level. This procedure is available in the ED and Medical Ward.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated permuted block sequences have been generated and assigned to 3 strata levels.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
RCT includes a nested longitudinal observational study of Infant Lung Function (ILF). HFNP WHO RCT participants will be offered follow-up ILF in a separately consented, HREC approved study(09/07/15/5.04 HREC/09/HNE/242) .
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
16/07/2012
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Actual
16/07/2012
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Date of last participant enrolment
Anticipated
30/04/2015
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Actual
1/05/2015
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Date of last data collection
Anticipated
2/10/2015
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Actual
10/09/2015
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Sample size
Target
202
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Accrual to date
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Final
202
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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John Hunter Children's Hospital - New Lambton
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Funding & Sponsors
Funding source category [1]
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Charities/Societies/Foundations
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Name [1]
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Hunter Children's Research Foundation
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Address [1]
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Locked Bag 1
Hunter Region Mail Centre,
2310. NSW
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Country [1]
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Australia
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Primary sponsor type
Hospital
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Name
John Hunter Children's Hospital
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Address
Locked Bag 1
Hunter Region Mail Centre
2310. NSW
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Country
Australia
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Secondary sponsor category [1]
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Charities/Societies/Foundations
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Name [1]
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Hunter Children's Research Foundation
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Address [1]
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Hunter Medical Research Institute
1/1 Kookaburra Circuit, New Lambton Heights NSW 2305
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Country [1]
284357
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Australia
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Other collaborator category [1]
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Individual
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Name [1]
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Professor Colin Royse
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Address [1]
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The University of Melbourne
Victoria 3010
Australia
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Country [1]
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Australia
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Other collaborator category [2]
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Individual
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Name [2]
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Dr Adam O'Brien
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Address [2]
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The Royal Children's Hospital Melbourne
Flemington Road
Parkville 3052
VICTORIA
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Country [2]
278548
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
287531
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Locked Bag 1
Hunter Region Mail Centre
2310
NSW
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
287531
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Approval date [1]
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18/06/2012
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Ethics approval number [1]
287531
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HNEHREC - 12/05/16/3.01; NSW HREC HREC/12/HNE/135
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Ethics committee name [2]
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Univeresity of Newcastle
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Ethics committee address [2]
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University Dr
Callaghan, 2308
NSW
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
293236
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Approval date [2]
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06/08/2012
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Ethics approval number [2]
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H-2012-0259.
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Summary
Brief summary
The primary purpose of the study is to test the efficacy of HFNP WHO compared to standard oxygen therapy (cold low flow) in the treatment of acute moderate bronchiolitis using time to event data (time to oxygen weaning) as the primary outcome. Three supporting safety outcomes and several exploratory outcomes are included in this single site clinical trial.
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Trial website
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Trial related presentations / publications
High-flow oxygen compared to standard nasal cannula oxygen does not reduce the median time on oxygen for infants with moderate bronchiolitis.
Presented at:Thoracic Society of Australia and New Zealand Scientific Meeting.
Perth Exhibition Centre. 2-6th April, 2016.
Kepreotes et al. High-flow oxygen compared to standard nasal cannula oxygen does not reduce the median time on oxygen for infants with moderate bronchiolitis. Respirology. 2016(21) S2 p.21-100.
Kepreotes. Caring for Country Kids with Bronchiolitis
Children’s Healthcare Australasia - Caring for Country Kids National Conference.
Convention Centre, Alice Springs, NT. 17-19 April, 2016
Results of the High-flow Warm Humidified Oxygen Randomised Control Trial.
Presented at: ACI NSW Respiratory Clinical Innovations Forum.
University of Technology, Sydney. 27th November, 2015.
Reduction of time on oxygen and length of stay for infants with moderate bronchiolitis using novel procedures that embed health policy in a paediatric clinical trial.
Presented at: ACI NSW Respiratory Clinical Innovations Forum.
University of Technology, Sydney. 27th November, 2015.
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Public notes
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Contacts
Principal investigator
Name
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Dr Elizabeth Kepreotes
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Address
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Johgn Hunter Children's Hospital
Locked Bag 1
Hunter Region Mail Centre
2310 NSW
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Country
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Australia
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Phone
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+61 02 49855173
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Fax
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+61 02 49213599
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Elizabeth Kepreotes
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Address
17349
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Locked Bag 1
Hunter Region Mail Centre
NSW
2310
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Country
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Australia
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Phone
17349
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+61 02 49855173
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Fax
17349
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+61 02 49213599
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Elizabeth Kepreotes
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Address
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Locked Bag 1
Hunter Region Mail Centre
NSW
2310
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Country
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Australia
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Phone
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+61 02 49855173
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Fax
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+61 02 49213599
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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
High-flow warm humidified oxygen versus standard low-flow nasal cannula oxygen for moderate bronchiolitis (HFWHO RCT): an open, phase 4, randomised controlled trial.
2017
https://dx.doi.org/10.1016/S0140-6736%2817%2930061-2
N.B. These documents automatically identified may not have been verified by the study sponsor.
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