Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001016921
Ethics application status
Not yet submitted
Date submitted
16/09/2011
Date registered
21/09/2011
Date last updated
21/09/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of high flow nasal prong (HFNP) oxygen therapy for viral bronchiolitis in children's wards of south-west Sydney.
Scientific title
The effect of high flow nasal prong oxygen therapy versus standard care on rate of intubation and requirements for intensive care in children with viral bronchiolitis
Secondary ID [1] 263027 0
N/A
Universal Trial Number (UTN)
U1111-1124-5169
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis 270753 0
Condition category
Condition code
Respiratory 270934 270934 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
High flow nasal prong therapy
Children with viral bronchiolitis requiring more than 2L/min oxygen will receive treatment as per protocol A (Control) or B (Treatment)

Protocol B:
-Patient given HFNP providing humidified and warmed to 37 degrees.
-The flow rate, set to optimise oxygen saturation, will be up to 8 L/min depending on patient comfort
-Duration of HFNP will vary depending on severity of the bronchiolitis. Breaks for nasal care or mobilization will be permitted.
-Other treatments such as drug therapy will be given according to standard protocols
Intervention code [1] 269369 0
Treatment: Other
Comparator / control treatment
Protocol A (control)
-Respiratory therapy presently available in the participating hospitals i.e. supplemental oxygen up to 2L/min provided by low-flow normal nasal prongs with unheated humidifier
-Other treatments such as drug therapy will be given according to standard protocols
Control group
Active

Outcomes
Primary outcome [1] 279601 0
Decrease in intubation
Timepoint [1] 279601 0
At the end of the treatment, it will be determined how many cases needed intubation
Primary outcome [2] 279610 0
Decrease in requirement for intensive care
Timepoint [2] 279610 0
At the end of the treatment, it will be determined how many cases needed transfer to intensive care unit
Secondary outcome [1] 294013 0
Reduction in transfer to children's hospital
Timepoint [1] 294013 0
At the end of the treatment, it will be evaluated how many cases could be managed well with HFNP and hence did not require transfer to a tertiary children's hospital.

Eligibility
Key inclusion criteria
*Male or female
*Clinical features typical of viral bronchiolitis
*Clinical features and SpO2 compatible with moderate to severe bronchiolitis
Minimum age
0 Months
Maximum age
24 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Complications of bronchiolitis discovered before enrolment, including pneumothorax
*Pneumonia plus or minus bronchiolitis
*Rapid progression of illness preventing opportunity for informed consent of parents or guardians.

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)
Consecutive participants will each be allocated an envelope from NHMRC Clinical Trials unit which contains a random number. The clinical trials centre will be contacted to break the code. If the study commences after 6 months from now, the Ingham Institute Clinical Trials Unit in Liverpool, NSW will have been established, and will be asked to administer the trial as our local service.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomiisation using computerised sequence generation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269835 0
Hospital
Name [1] 269835 0
Campbelltown Hospital
Country [1] 269835 0
Australia
Funding source category [2] 269909 0
Hospital
Name [2] 269909 0
Mount Druitt Hospital
Country [2] 269909 0
Australia
Primary sponsor type
Individual
Name
Prof John Whitehall
Address
Department of Paediatrics
School of Medicine, Campbelltown campus
University of Western Sydney
Locked Bag 1797
Penrith NSW 2751
Country
Australia
Secondary sponsor category [1] 268867 0
University
Name [1] 268867 0
University of Western Sydney
Address [1] 268867 0
Locked Bag 1797
Penrith
NSW 2751
Country [1] 268867 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 271805 0
University of Western Sydney
Ethics committee address [1] 271805 0
Locked Bag 1797
Penrith
NSW 2751
Ethics committee country [1] 271805 0
Australia
Date submitted for ethics approval [1] 271805 0
01/10/2011
Approval date [1] 271805 0
Ethics approval number [1] 271805 0

Summary
Brief summary
The primary purpose of the study is to conduct a clinical trial on the use of HFNP therapy on infants with viral bronchiolitis requiring ventilator support and compare it with the standard care at the Campbelltown and Mt Druitt Hospitals to see effect of HFNP therapy in reducing the need for intubation and cost of transferring children to specialized children hospitals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33144 0
Address 33144 0
Country 33144 0
Phone 33144 0
Fax 33144 0
Email 33144 0
Contact person for public queries
Name 16391 0
John Whitehall
Address 16391 0
Department of Paediatrics
School of Medicine
Campbelltown Campus
University of Western Sydney
Locked Bag 1797, Penrith NSW 2751
Country 16391 0
Australia
Phone 16391 0
+612 46203787
Fax 16391 0
+612 46203891
Email 16391 0
[email protected]
Contact person for scientific queries
Name 7319 0
John Whitehall
Address 7319 0
Department of Paediatrics
School of Medicine
Campbelltown Campus
University of Western Sydney
Locked Bag 1797, Penrith NSW 2751
Country 7319 0
Australia
Phone 7319 0
+612 46203787
Fax 7319 0
+612 46203891
Email 7319 0
[email protected]

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
No additional documents have been identified.