Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001469404
Ethics application status
Approved
Date submitted
18/10/2016
Date registered
21/10/2016
Date last updated
28/11/2019
Date data sharing statement initially provided
28/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Solar powered oxygen systems in remote health centers in Papua New Guinea – a large scale implementation effectiveness trial
Scientific title
Solar powered oxygen systems in remote health centers in Papua New Guinea – a large scale implementation effectiveness trial: impact on children with severe pneumonia
Secondary ID [1] 290346 0
Nil
Universal Trial Number (UTN)
U1111-1188-8025
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumonia 300625 0
Hypoxaemia 300626 0
Condition category
Condition code
Public Health 300474 300474 0 0
Health service research
Respiratory 300489 300489 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Introduction of solar-powered oxygen concentrators into 36 health centres in Papua New Guinea. This project will evaluate the implementation issues in the national scale-up of oxygen concentrators and pulse oximeters in the rural areas PNG, a high mortality developing county. The implementation steps include defining the criteria for facilities where this technology (oxygen concentrators and pulse oximeters) are appropriate, assessment of power supplies and power requirements of each health facility, the optimal design of a solar power system to power the equipment, defining specifications for oxygen concentrators and other oxygen equipment that will function in remote environments, implementation logistics in remote settings, developing the engineering capacity required to sustain such a program at scale, and training on oxygen equipment and the treatment of children with severe respiratory infection.

Training is both in workshops in each province, and on-site training, where a team member visits the health facility as part of improved monitoring and supervision, and conducts training at that time. The treatment of pneumonia follows standard WHO treatment based on the Hospital Care for Children guidelines, and the oxygen therapy guidelines (WHO Clinical use of oxygen in children).

The implementation is expected to take 6 months, but because it is multifaceted and multi-site it may extend beyond this depending on the feasibility in different locations.

The project will evaluate these issues down to a rural district hospital and major health center level (i.e. the smallest health centers that admit children). Implementation involves the National Department of Health, the provincial paediatricians, local technicians, and a solar contractor.

The programmatic and implementation issues we will evaluate include technical questions regarding power supply irregularity in remote settings, the role of solar power, the optimal concentrator to use in remote tropical environments, the role and utility of hand-held oximeters particularly when used by nurses and community health workers, training issues in oxygen concentrators and the use of pulse oximetry, program costs, the engineering capacity required to maintain a program, the integration of these technologies with clinical guidelines for the standard treatment of children with pneumonia and integrated case management, and referral problems. These issues have not been addressed in a systematic way in developing countries and they are impediments to progress in improving children’s access to better care for severe pneumonia.
Intervention code [1] 296163 0
Treatment: Devices
Comparator / control treatment
Historical, prior to the use of oxygen concentrators and solar power in these health centres. This baseline data is from routine health facility recording information from admission record books in the 36 health facilities. The baseline data will be gathered from January 2013 to December 2015. The duration may vary depending on the completeness of the routine health admission books, but we will aim for at least 2 years, and optimally 3 years of pre-intervention data.
Control group
Historical

Outcomes
Primary outcome [1] 299913 0
The main learnings from this project will be to better understand what is required to achieve a national scale with effective oxygen systems, including the use of oxygen concentrators and pulse oximeters, especially the challenges of achieving this at a district hospital and health centre level, with alternative renewable power sources. The methods of assessment will be qualitative evaluations throughout the implementation process, and interviews with stakeholders..
Timepoint [1] 299913 0
2 years. The time-points for qualitative evaluations and interviews with stakeholders will be at baseline prior to implementation, completion of implementation, and every 6 months thereafter up to at least 2 years post implementation. The issues assessed at different time points will differ - from early on methods of implementation and the successful approaches, to later issues f sustainability and what worked and what did not.
Primary outcome [2] 299920 0
Case fatality rates from severe pneumonia, as assessed by data linkage to health centre medical records.
Timepoint [2] 299920 0
2 years
Secondary outcome [1] 328510 0
Referral rates in children with severe pneumonia, based on routine health facility data recording
Timepoint [1] 328510 0
2 years

Eligibility
Key inclusion criteria
Health facilities in remote rural PNG. Health facilities will be included if they have a high burden of pneumonia, difficulty getting access to oxygen, difficulties with mains power supply, and the staff are motivated to be involved.
This study does not involve the allocation of patients to a treatment group, but involves the evaluation of the implementation of a public health program, which would be expected to have an impact on clinical outcomes. There are no individual patient data recording, or individual patient recruitment, the evaluation is based on routine health facility data. Thus the criteria below are merely indicative of children managed in the 36 health facilities, not selection criteria for recruitment. Data on children aged 1 week to 15 years, recorded in the admission record books of the health facilities, will be gathered to assess the pneumonia case fatality rate outcome.
Minimum age
1 Weeks
Maximum age
15 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria, as there is no specific recruitment to the study. It is an implementation effectiveness evaluation based on routine health facility data, and based on normal health facility functioning.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No, as all children managed in these health facilities will benefit from this public health / clinical intervention
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Simple statistical analysis of case fatality rates based on routine data pre- and post-intervention. Qualitative data to understand how and where the intervention is effective, and where in a public health setting.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2016
Actual
1/03/2015
Date of last participant enrolment
Anticipated
1/07/2018
Actual
30/08/2019
Date of last data collection
Anticipated
1/12/2018
Actual
30/08/2019
Sample size
Target
15000
Accrual to date
Final
15000
Recruitment outside Australia
Country [1] 8327 0
Papua New Guinea
State/province [1] 8327 0
Highlands region provinces

Funding & Sponsors
Funding source category [1] 294734 0
Charities/Societies/Foundations
Name [1] 294734 0
Bill and Melinda Gates Foundation
Country [1] 294734 0
United States of America
Funding source category [2] 294739 0
Charities/Societies/Foundations
Name [2] 294739 0
RE Ross Trust
Country [2] 294739 0
Australia
Primary sponsor type
University
Name
Centre for International Child Health, University of Melbourne and Murdoch Children's Research Institute
Address
Centre for International Child Health
University of Melbourne, Department of Paediatrics, MCRI
50 Flemington Road
Parkville, 3052
Victoria
Country
Australia
Secondary sponsor category [1] 293587 0
None
Name [1] 293587 0
Address [1] 293587 0
Country [1] 293587 0
Other collaborator category [1] 279268 0
Government body
Name [1] 279268 0
Family Health Services Branch, National Department of Health
Address [1] 279268 0
Waigani House, PO Box 446
Waigani, 131
National Capital District
Papua New Guinea
Country [1] 279268 0
Papua New Guinea

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296152 0
University of Melbourne, Human Research Ethics Committee
Ethics committee address [1] 296152 0
Ethics committee country [1] 296152 0
Australia
Date submitted for ethics approval [1] 296152 0
01/10/2015
Approval date [1] 296152 0
26/02/2016
Ethics approval number [1] 296152 0
1543797.1

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1183 1183 0 0
/AnzctrAttachments/371672-standardproject updated 20160202.doc (Protocol)

Contacts
Principal investigator
Name 69746 0
Prof Trevor Duke
Address 69746 0
Centre for International Child Health
University of Melbourne Department of Paediatrics
50 Flemington Road, Parkville, VIC 3052
Country 69746 0
Australia
Phone 69746 0
+61 3 9345 5968
Fax 69746 0
Email 69746 0
[email protected]
Contact person for public queries
Name 69747 0
Trevor Duke
Address 69747 0
Centre for International Child Health
University of Melbourne Department of Paediatrics
50 Flemington Road, Parkville, VIC 3052
Country 69747 0
Australia
Phone 69747 0
+61 3 9345 5968
Fax 69747 0
Email 69747 0
[email protected]
Contact person for scientific queries
Name 69748 0
Trevor Duke
Address 69748 0
Centre for International Child Health
University of Melbourne Department of Paediatrics
50 Flemington Road, Parkville, VIC 3052
Country 69748 0
Australia
Phone 69748 0
+61 3 9345 5968
Fax 69748 0
Email 69748 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseSolar-powered oxygen, quality improvement and child pneumonia deaths: A large-scale effectiveness study.2021https://dx.doi.org/10.1136/archdischild-2020-320107
N.B. These documents automatically identified may not have been verified by the study sponsor.