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Improving oxygen therapy for children and neonates in secondary hospitals in Nigeria: study protocol for a stepped-wedge cluster randomised trial.

Improving oxygen therapy for children and neonates in secondary hospitals in Nigeria: study protocol for a stepped-wedge cluster randomised trial.
Author Information (click to view)

Graham HR, Ayede AI, Bakare AA, Oyewole OB, Peel D, Gray A, McPake B, Neal E, Qazi S, Izadnegahdar R, Falade AG, Duke T,


Graham HR, Ayede AI, Bakare AA, Oyewole OB, Peel D, Gray A, McPake B, Neal E, Qazi S, Izadnegahdar R, Falade AG, Duke T, (click to view)

Graham HR, Ayede AI, Bakare AA, Oyewole OB, Peel D, Gray A, McPake B, Neal E, Qazi S, Izadnegahdar R, Falade AG, Duke T,

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Trials 2017 10 2718(1) 502 doi 10.1186/s13063-017-2241-8
Abstract
BACKGROUND
Oxygen is a life-saving, essential medicine that is important for the treatment of many common childhood conditions. Improved oxygen systems can reduce childhood pneumonia mortality substantially. However, providing oxygen to children is challenging, especially in small hospitals with weak infrastructure and low human resource capacity.

METHODS/DESIGN
This trial will evaluate the implementation of improved oxygen systems at secondary-level hospitals in southwest Nigeria. The improved oxygen system includes: a standardised equipment package; training of clinical and technical staff; infrastructure support (including improved power supply); and quality improvement activities such as supportive supervision. Phase 1 will involve the introduction of pulse oximetry alone; phase 2 will involve the introduction of the full, improved oxygen system package. We have based the intervention design on a theory-based analysis of previous oxygen projects, and used quality improvement principles, evidence-based teaching methods, and behaviour-change strategies. We are using a stepped-wedge cluster randomised design with participating hospitals randomised to receive an improved oxygen system at 4-month steps (three hospitals per step). Our mixed-methods evaluation will evaluate effectiveness, impact, sustainability, process and fidelity. Our primary outcome measures are childhood pneumonia case fatality rate and inpatient neonatal mortality rate. Secondary outcome measures include a range of clinical, quality of care, technical, and health systems outcomes. The planned study duration is from 2015 to 2018.

DISCUSSION
Our study will provide quality evidence on the effectiveness of improved oxygen systems, and how to better implement and scale-up oxygen systems in resource-limited settings. Our results should have important implications for policy-makers, hospital administrators, and child health organisations in Africa and globally.

TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry: ACTRN12617000341325 . Retrospectively registered on 6 March 2017.

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