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Trial registered on ANZCTR


Registration number
ACTRN12617000341325
Ethics application status
Approved
Date submitted
1/03/2017
Date registered
6/03/2017
Date last updated
6/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving oxygen therapy for children in 12 Nigerian hospitals: a stepped-wedge cluster randomised field trial
Scientific title
Evaluating the effectiveness of an improved oxygen system using pulse-oximetry and supplemental oxygen for the treatment of infants and children: a large-scale multi-center stepped-wedge cluster randomised implementation trial in 12 Nigerian hospitals
Secondary ID [1] 291315 0
None
Universal Trial Number (UTN)
1111-1193-6364
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pneumonia 302292 0
neonatal conditions 302293 0
quality of care 302294 0
hypoxaemia 302295 0
Condition category
Condition code
Respiratory 301875 301875 0 0
Other respiratory disorders / diseases
Reproductive Health and Childbirth 301876 301876 0 0
Complications of newborn
Public Health 301877 301877 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Comprehensive oxygen therapy system
We will implement a comprehensive oxygen therapy system in 12 secondary health facilities in south-west Nigeria. This system will include:
- oxygen equipment: oxygen concentrators, pulse oximetry, and oxygen delivery devices. Equipment will be installed using a participatory approach, involving local technicians and management in the procurement, delivery, installation and commissioning. Equipment will be selected and planned with input from an expert biomedical engineer with extensive experience with oxygen systems.
- education: practical training for nursing and medical staff on hypoxaemia and the clinical use of oxygen. Training will be delivered using an 'apprentice' model, training trainers on-site and then supervising them to train their colleagues (based on the WHO oxygen guidelines and the WHO Pocketbook of Hospital Care for Children). Training will be developed by paediatricians and educators with experience in oxygen therapy, and delivered by trained clinical educators. Comprehensive half-day training will be led by the coordination team at the start of implementation at each hospital (in conjunction with equipment installation and commissioning) - and will be repeated approximately 2-3 times to capture all relevant staff (depending on the size of the hospital). All training information will be provided to the hospitals to conduct future training as new staff enter the hospital, rotate around wards, or otherwise as needed.
- improved power supply: solar power systems and/or dedicated generators with UPS/battery back-up. This will be provided by an experience solar power company.
- supportive supervision and feedback: we use an quality improvement approach to involve local stakeholders in the planning, implementation and evaluation of the project. This will involve study nurses working closely with each hospital, and regular visits by the project team (approximately 3 monthly). Study nurses primary role is to coordinate local data collection, but they are also available as a first port of call for practical assistance in using the oxygen equipment correctly, and communicating practical challenges with the use of oxygen to be addressed by the project coordination team.
- maintenance and repair process: training for hospital and central technicians on preventive maintenance and repair of oxygen concentrators and other equipment (a single 3-day training for the central engineers and one engineer from each hospital); log-books and repair manuals for documenting maintenance; spare part supply; regular maintenance visits (3 monthly). Training will be developed by a biomedical engineer with expertise in oxygen, with input from clinicians, and delivered by trained engineers and clinicians.

In keeping with a quality improvement approach, particular aspects of this intervention may be individualised within each hospital to optimise fidelity of implementation. We will collect data on implementation processes, and be able to report on the fidelity of implementation within different hospitals.

The intervention will be stepped out to hospitals over a 12 month period, with a 4 month baseline period (no intervention in all hospitals) and a final 8 month period after all hospitals have received the intervention.
Intervention code [1] 297341 0
Treatment: Devices
Intervention code [2] 297342 0
Treatment: Other
Comparator / control treatment
We use a stepped-wedge cluster randomised design, with randomisation at the hospital level. Thus, all hospitals will start as controls, then proceed into intervention at defined time points.

In the control situation, all hospitals will be provided with pulse oximeters and basic training to encourage their use on all children and neonates admitted to hospital. This is important for obtaining accurate pre-intervention assessment of hypoxaemia prevalence. The basic pulse oximetry training will be developed by a paediatrician educator and delivered by trained clinicians. It will consist of a 1 hour practical session on the importance of detecting hypoxaemia, and the use of pulse oximetry. It will be delivered as a single session to a convenience sample of paediatric doctors and nurses available on the day, and senior staff are encouraged to share the training with their colleagues. Study nurses will be available as a first port of call for practical assistance in using the pulse oximeters correctly, and communicating practical challenges with pulse oximetry to be addressed by the project coordination team.

All hospitals will start as 'control' hospitals. The intervention will be stepped out to hospitals over a 12 month period, with a 4 month baseline period (no intervention in all hospitals) and a final 8 month period after all hospitals have received the intervention.
Control group
Active

Outcomes
Primary outcome [1] 301305 0
Pneumonia case fatality rate, assessed from data systematically extracted from routine clinical records
Timepoint [1] 301305 0
2 years, according to stepped wedge design:
- Clinical data extracted from routine clinical records, for 2 years retrospectively, then for 2 years throughout the period of the main study (4 months all hospitals control, 12 month stepped period, 8 month all hospitals intervention).
Primary outcome [2] 301307 0
Neonatal case fatality rate, assessed from data systematically extracted from routine clinical records
Timepoint [2] 301307 0
2 years, according to stepped wedge design:
- Clinical data extracted from routine clinical records, for 2 years retrospectively, then for 2 years throughout the period of the main study (4 months all hospitals control, 12 month stepped period, 8 month all hospitals intervention).
Primary outcome [3] 301329 0
Evaluation of implementation success, including comparison between different hospitals. This will involve mixed-methods evaluation using data systematically extracted from routine clinical records, data from maintenance and equipment use logs, interviews with project personnel and hospital staff, and records of costs. Important implementation questions include:
- how to implement pulse oximetry and oxygen therapy in hospitals
- how to achieve sustainable maintenance and repair in hot, humid, dusty environments
- how to achieve adequate power supply for equipment in difficult environments
- how to scale up oxygen at a state and regional scale
Timepoint [3] 301329 0
We will collect quantitative and qualitative data from site visits, formal data collection, and interviews at various time points:
- Clinical data extracted from routine clinical records, for 2 years retrospectively, then for 2 years throughout the period of the main study (4 months all hospitals control, 12 month stepped period, 8 month all hospitals intervention).
- Equipment evaluation at baseline, and every 3 months for the duration of the intervention period. Log books completed on a weekly basis by hospital staff.
- Interviews conducted with staff at mid-point and end of intervention period.
- Knowledge and skill tests conducted on those who participate in training (before and immediately after training), developed for study.
- Facility and equipment assessment, conducted at baseline and end of study period.
- Continuous program monitoring and feedback from study nurses in hospitals.
Secondary outcome [1] 332272 0
Quality of care measures (clinical care practices for hypoxaemia, pneumonia, malaria, prematurity), using composite measures derived from the WHO Pocketbook of Hospital Care for Children guidelines. The focus here is on the quality of care 'processes' (rather than the 'structural' and 'impact' aspects of quality of care).
Timepoint [1] 332272 0
2 years, according to stepped wedge design:
- Clinical practice data extracted from routine clinical records, for 2 years retrospectively, then for 2 years throughout the period of the main study (4 months all hospitals control, 12 month stepped period, 8 month all hospitals intervention). Quality of care measures are derived from a composite of the data on actual clinical practice, and will be analysed using appropriate stepped-wedge cluster randomised trial approaches to determine intervention effect and describe trends in various quality of care components pre-intervention and post-intervention. These quality of care 'processes' outcomes will be reported with reference to the broader 'structural' and 'impact' aspects of quality of care - but the focus is on the actual quality of care practices.
Secondary outcome [2] 332306 0
Malaria case fatality rate, assessed from data systematically extracted from routine clinical records
Timepoint [2] 332306 0
2 years, according to stepped wedge design:
- Clinical practice data extracted from routine clinical records, for 2 years retrospectively, then for 2 years throughout the period of the main study (4 months all hospitals control, 12 month stepped period, 8 month all hospitals intervention).
Secondary outcome [3] 332307 0
Preterm neonatal case fatality rate, assessed from data systematically extracted from routine clinical records
Timepoint [3] 332307 0
2 years, according to stepped wedge design:
- Clinical data extracted from routine clinical records, for 2 years retrospectively, then for 2 years throughout the period of the main study (4 months all hospitals control, 12 month stepped period, 8 month all hospitals intervention).

Eligibility
Key inclusion criteria
We will select hospitals based on the following criteria:
1. Challenging implementation environment. Implementation previously has generally been conducted in sites that are most conducive to the intervention. To advance the science, we seek to understand implementation constraints in the challenging environments, such as small health facilities with difficult access.
2. High burden of pneumonia and high mortality. This intervention should target the areas currently facing the most significant burden of disease. This is important for maximising impact, enabling measurement of effect, and to address the biggest needs of participating communities.
3. Fit with state/national health priorities. This should be done in real-life settings, and be compatible with the priorities set out by state and national administrative bodies. This is important for ongoing sustainability, maximising whole-of-system impact, and in answering the most relevant questions for decision-makers.

We will collect data on all children and neonates admitted to these hospitals.
Minimum age
No limit
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 normal health facility functioning.

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)
Allocation is done by central randomisation (by computer) at the hospital level (there is no individual allocation), after determination of all hospital eligibility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
We have chosen a stepped-wedge cluster randomised trial (SWCRT) design, using methodology described by Hemming et al. (2015). This enables a pragmatic approach to implementation (not requiring all 12 hospitals to be set up simultaneously) and enables hospitals to act both as their own control and as a control to other hospitals.

Our SWCRT design involves:
- all 12 hospitals receiving the intervention at different time points, according to randomisation at the hospital level
- we are using 4 clusters of 3 hospitals (stratified to include 1 large and 2 small hospitals in each cluster), with steps at 4 month intervals
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We will follow the widely accepted Hussey and Hughes methodology for statistical analysis of SWCRT designs using cross-sectional data(Hussey & Hughes, 2007). This involves analysis of variation within- and between-clusters, and methods of analysis that account both for this variation and for the effects of time – specifically generalised linear mixed model (GLMM) or generalised estimating equations (GEE)(Hemming et al., 2015; Hussey & Hughes, 2007).

There are two unique considerations for SWCRT designs compared to traditional parallel RCTs. Firstly, we need to allow for the confounding effect of time (which typically increases the sample size needed to achieve adequate power). Secondly, each cluster effectively acts as its own control by contributing both exposed and unexposed observations (typically enhancing the precision) .

Characteristics of the individuals and clusters will be summarised by exposure status, to illustrate potential imbalance between exposed and unexposed and allow for discussion of potential biases. Number of observations within each cluster will be expressed by overlaying the summary numbers onto a Step-Wedge diagram. Summary data will include the numbers analysed, the average cluster size, cluster characteristics, and important patient characteristics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/04/2016
Date of last participant enrolment
Anticipated
30/11/2017
Actual
Date of last data collection
Anticipated
30/11/2017
Actual
Sample size
Target
20000
Accrual to date
Final
Recruitment outside Australia
Country [1] 8702 0
Nigeria
State/province [1] 8702 0
Oyo, Ondo, Osun, Ogun

Funding & Sponsors
Funding source category [1] 295783 0
Charities/Societies/Foundations
Name [1] 295783 0
Bill and Melinda Gates Foundation (BMGF)
Country [1] 295783 0
United States of America
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] 294632 0
None
Name [1] 294632 0
Address [1] 294632 0
Country [1] 294632 0
Other collaborator category [1] 279458 0
Hospital
Name [1] 279458 0
University College Hospital Ibadan
Address [1] 279458 0
University College Hospital Ibadan
Queen Elizabeth Road
Ibadan
Oyo state
Country [1] 279458 0
Nigeria

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297081 0
University of Melbourne, Human Research Ethics Committee
Ethics committee address [1] 297081 0
Ethics committee country [1] 297081 0
Australia
Date submitted for ethics approval [1] 297081 0
01/10/2015
Approval date [1] 297081 0
26/02/2016
Ethics approval number [1] 297081 0
1543797.1

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1543 1543 0 0
/AnzctrAttachments/372463-ETHICS_standardproject_02022015.doc

Contacts
Principal investigator
Name 72910 0
Prof Trevor Duke
Address 72910 0
Centre for International Child Health
University of Melbourne Department of Paediatrics
50 Flemington Road, Parkville, VIC 3052
Country 72910 0
Australia
Phone 72910 0
+61 3 9345 5968
Fax 72910 0
Email 72910 0
trevor.duke@rch.org.au
Contact person for public queries
Name 72911 0
Hamish Graham
Address 72911 0
Centre for International Child Health
University of Melbourne Department of Paediatrics
50 Flemington Road, Parkville, VIC 3052
Country 72911 0
Australia
Phone 72911 0
+61 3 9345 6262
Fax 72911 0
Email 72911 0
hamish.graham@rch.org.au
Contact person for scientific queries
Name 72912 0
Hamish Graham
Address 72912 0
Centre for International Child Health
University of Melbourne Department of Paediatrics
50 Flemington Road, Parkville, VIC 3052
Country 72912 0
Australia
Phone 72912 0
+61 3 9345 6262
Fax 72912 0
Email 72912 0
hamish.graham@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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4652Study results articleYes 2019 372463-(Uploaded-10-02-2020-11-13-07)-Journal results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImproving oxygen therapy for children and neonates in secondary hospitals in Nigeria: Study protocol for a stepped-wedge cluster randomised trial.2017https://dx.doi.org/10.1186/s13063-017-2241-8
EmbaseOxygen systems to improve clinical care and outcomes for children and neonates: A stepped-wedge cluster-randomised trial in Nigeria.2019https://dx.doi.org/10.1371/journal.pmed.1002951
EmbaseOxygen systems and quality of care for children with pneumonia, malaria and diarrhoea: Analysis of a stepped-wedge trial in Nigeria.2021https://dx.doi.org/10.1371/journal.pone.0254229
N.B. These documents automatically identified may not have been verified by the study sponsor.