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Trial registered on ANZCTR


Registration number
ACTRN12612001294842
Ethics application status
Approved
Date submitted
27/11/2012
Date registered
13/12/2012
Date last updated
13/12/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of bubble-continuous positive airway pressure (CPAP) on outcome of severe childhood pneumonia and neonatal respiratory distress in children in Papua New Guinea and Solomon Islands
Scientific title
In the management of severe pneumonia in children and neonatal respiratory distress, does bubble-CPAP, when delivered by a modified oxygen concentrator, compared to standard flow oxygen therapy, result in lower risk of death or clinical failure
Secondary ID [1] 281591 0
Nil
Universal Trial Number (UTN)
U1111-1137-3401
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia in children 287872 0
Neonatal respiratory distress 287877 0
Condition category
Condition code
Respiratory 288238 288238 0 0
Other respiratory disorders / diseases
Infection 288243 288243 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Bubble-continuous positive airway pressure (CPAP) using a modified oxygen concentrator, the level of CPAP being 4-8 cmH20, with a fraction of inspired oxygen between 25-60%, using flow rates of around 6 L/min for neonates and 10 L/min for older infants and children. CPAP will be administered continuously, until signs of severe respiratory distress and hypoxaemia resolve. Daily assessments of the degree of respiratory distress will guide when it is clinically safe to stop CPAP
Intervention code [1] 286118 0
Treatment: Devices
Intervention code [2] 286123 0
Treatment: Other
Comparator / control treatment
Standard oxygen therapy according to WHO recommendations using oxygen concentrators or oxygen cylinders. Oxygen will be administered continuously, until signs of severe respiratory distress and hypoxaemia resolve. Daily assessments of the degree of respiratory distress will guide when it is clinically safe to stop oxygen therapy
Control group
Active

Outcomes
Primary outcome [1] 288428 0
Mortality
Timepoint [1] 288428 0
Hospital discharge
Secondary outcome [1] 300136 0
Clinical failure: at 5 days (or more) after enrollment, the persistance of severe respiratory distress. This will be assessed clinically using the following criteria:

3 or more of the fllowing signs will constitute severe respiratory distress and fulfil the definition of clinical failure at 5 days or more after commencing treatment:

1. Tachypnoea (RR >60 for neonates and >50 for older children)
2. Tachycardia (HR >180 for neonates and >160 for older children)
3. Moderate-severe chest in-drawing
4. Tracheal tug, grunting or head nodding
5. Cyanosis or hypoxaemia (SpO2<90%, or <86% in highlands)
Timepoint [1] 300136 0
5 days or more after commencing treatment
Secondary outcome [2] 300147 0
Readmission with severe pneumonia within one month of hospital discharge
Timepoint [2] 300147 0
Up to one month after hospital discharge

Eligibility
Key inclusion criteria
Children admitted with pneumonia and hypoxaemia (SpO2<90%, or less than 86% in highlands) or neonates with respiratory distress and hypoxaemia.
Minimum age
No limit
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Congenital heart disease
Previous enrollment
Pneumothorax

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)
We will use sealed envelopes to randomly assign the children to either standard oxygen therapy or bubble-CPAP. The two arms will be compared for rates of treatment failure and death.

Block randomization will occur, stratified according to age (neonatal or older). Each hospital will have its own unique randomization sequences, to ensure balance.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random sequence of numbers will be generated using http://www.stattools.net/RandomInt_Pgm.php to which the investigators enrolling patients will be blinded.

Random seed 1 for Pneumonia and Random seed 2 for Neonates (accessed July 16, 2012).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Multi-centre: 8 hospital: Port Moresby, Mt Hagen, Goroka, Mendi, Alotau, Angau, Vanimo, and Honiara

Data Safety and Monitoring Committee

All other treatment standardised according to WHO recommendations and local Standard Treatment Guidelines
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
2800
Accrual to date
Final
Recruitment outside Australia
Country [1] 4691 0
Papua New Guinea
State/province [1] 4691 0
Country [2] 4692 0
Solomon Islands
State/province [2] 4692 0

Funding & Sponsors
Funding source category [1] 286396 0
Charities/Societies/Foundations
Name [1] 286396 0
Rotary Australia
Country [1] 286396 0
Australia
Primary sponsor type
University
Name
School of Medicine & Health Sciences, University of Papua New Guinea
Address
Port Moresby General Hospital
3 Mile, Taurama Road
National Capital District
Country
Papua New Guinea
Secondary sponsor category [1] 285180 0
University
Name [1] 285180 0
University of Melbourne
Address [1] 285180 0
Centre for International Child Health
Department of Paediatrics
50 Flemington Road, Parkville, 3052
Victoria
Country [1] 285180 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288461 0
Research & Ethics Committee, School of Medicine & Health Sciences, University of Papua New Guinea
Ethics committee address [1] 288461 0
Ethics committee country [1] 288461 0
Papua New Guinea
Date submitted for ethics approval [1] 288461 0
Approval date [1] 288461 0
27/09/2012
Ethics approval number [1] 288461 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34986 0
Prof Trevor
Address 34986 0
Centre for International Child Health
Department of Paediatrics, University of Melbourne
Royal Children's Hospital
50 Flemington Road, Parkville, 3052
Victoria, Australia
Country 34986 0
Australia
Phone 34986 0
+61 39345 5968
Fax 34986 0
Email 34986 0
trevor.duke@rch.org.au
Contact person for public queries
Name 18233 0
Trevor Duke
Address 18233 0
Centre for International Child Health
Department of Paediatrics, University of Melbourne
Royal Children's Hospital
50 Flemington Road, Parkville, 3052
Victoria, Australia
Country 18233 0
Australia
Phone 18233 0
+61 39345 5968
Fax 18233 0
+61 3 9345 6667
Email 18233 0
trevor.duke@rch.org.au
Contact person for scientific queries
Name 9161 0
Trevor Duke
Address 9161 0
Centre for International Child Health
Department of Paediatrics, University of Melbourne
Royal Children's Hospital
50 Flemington Road, Parkville, 3052
Victoria, Australia
Country 9161 0
Australia
Phone 9161 0
+61 3 9345 5968
Fax 9161 0
+61 3 9 345 6667
Email 9161 0
trevor.duke@rch.org.au

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.