Improving oxygen therapy for children in 12 Nigerian hospitals: a stepped-wedge cluster randomised field trial

• Register: ANZCTR
• Last refreshed on: 13 March 2017
• Main ID: ACTRN12617000341325
• Date of registration: 06/03/2017
• Prospective Registration: No
• Primary sponsor: Centre for International Child Health, University of Melbourne and Murdoch Children's Research Institute
• 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
• Date of first enrolment: 4/04/2016
• Target sample size: 20000
• Recruitment status: Recruiting
• URL: http://www.anzctr.org.au/ACTRN12617000341325.aspx
• Study type: Interventional
• Study design: Randomised controlled trial Other
• Phase: Not Applicable

Health Condition(s) or Problem(s) studied

quality of care

hypoxaemia

neonatal conditions

pneumonia

Intervention(s)

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.