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URL: https://dx.doi.org/DOI:10.17504/protocols.io.88mhzu6

Authors: Solomon Hailemariam1, 2, 3*, Yabibal Gebeyehu4, Eskinder Loha1, 5, Kjell Arne Johansson2, Bernt Lindtjørn1, 2

Summary: Abstract Background: Hypoxemia is common in children with pneumonia. The World Health Organization and United Nations Children’s Fund developed the Integrated Management of Childhood Illness strategy for diagnosing pneumonia. But the strategy has limitations to accurately detect hypoxemia in children with severe pneumonia. This study will assess whether pulse oximetry improves health workers’ performance in diagnosing severe childhood pneumonia and whether the pulse oximeter is a cost-effective tool to improve diagnoses of severe pneumonia at primary health care units in South Ethiopia.Methods: A cluster-randomized controlled trial will be conducted at 24 health centres in southern Ethiopia from September 2018 to February 2019. The trial has two arms: the first arm will examine the combined use of the Integrated Management of Childhood Illness (IMCI) strategy with pulse oximetry, and the second arm will examine the use of the IMCI strategy alone. The study population will include children between 2 months and 59 months of age who present with cough or difficult breathing. The primary outcome of this trial is severe childhood pneumonia, as diagnosed via the IMCI guideline and pulse oximetry. Secondary outcomes will be referred cases of severe pneumonia, and treatment failure on day 14 after enrolment. A cost effectiveness study will be conducted simultaneously.Discussion: This study will determine if using a pulse oximeter at health facilities in rural Southern Ethiopia improves diagnostic accuracy for paediatric severe pneumonia. Our secondary aim will be to evaluate if the benefit of pulse oximetry justifies its cost. Trial registration: PACTR201807164196402(14/06/2018). URL:https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=3466.

Associated Publications: Tesfaye SH, Gebeyehu Y, Loha E, Johansson KA, Lindtjørn B, Pulse oximeter with integrated management of childhood illness for diagnosis of severe childhood pneumonia at rural health institutions in Southern Ethiopia: results from a cluster-randomised controlled trial. BMJ Open 10(6). doi: 10.1136/bmjopen-2020-036814

Affiliations: 1 School of Public Health, Hawassa University, Hawassa, Ethiopia , 2 Centre for International Health, University of Bergen, Bergen, Norway, 3 School of Public Health, Dilla University, Dilla, Ethiopia , 4 School of Medicine, Dilla University, Dilla, Ethiopia, 1 School of Public Health, Hawassa University, Hawassa, Ethiopia , 5 Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom, 2 Centre for International Health, University of Bergen, Bergen, Norway, 1 School of Public Health, Hawassa University, Hawassa, Ethiopia , 2 Centre for International Health, University of Bergen, Bergen, Norway

External URL: https://doi.org/10.1136/bmjopen-2020-036814

Version: 1

Publication Date: 2019

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