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Randomized Controlled Trial
. 2017 Oct 27;18(1):502.
doi: 10.1186/s13063-017-2241-8.

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

Hamish R Graham  1   2 , Adejumoke I Ayede  3   4 , Ayobami A Bakare  3 , Oladapo B Oyewole  3 , David Peel  5 , Amy Gray  6 , Barbara McPake  7 , Eleanor Neal  6 , Shamim Qazi  8 , Rasa Izadnegahdar  9 , Adegoke G Falade  3   4 , Trevor Duke  6
Affiliations
Randomized Controlled Trial

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

Hamish R Graham et al. Trials. .

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.

Keywords: Child; Developing countries; Infant; Oximetry; Pneumonia; Quality improvement; Solar energy; Stepped-wedge design; Theory-based evaluation.

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Conflict of interest statement

Ethics approval and consent to participate

This study obtained ethics approval from the University of Melbourne (1543797.1) and University of Ibadan/University College Hospital Ethics Committee, Ibadan, Nigeria (UI/EC/16/0413). Hospital directors consented for involvement of their hospitals, and individual consent will be obtained from participants of focus groups and interviews.

Consent for publication

All authors have reviewed the final manuscript, and consent for publication. There is no personal or private data contained in this manuscript.

Competing interests

Some authors received salary support through the Bill and Melinda Gates Foundation project grant (HRG, TD, EN, AGF, AIA, AAB, OBO, DP). The authors declare they do not have any other competing interests to declare.

Shamim Qazi is a staff member of the World Health Organisation. The expressed views and opinions do not necessarily express the policies of the World Health Organisation.

Publisher’s note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure of stepped-wedge study design, illustrating stepped roll-out of the intervention, enrolment and data collection activities over time
See this image and copyright information in PMC

References

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