Project Details

Evaluating novel pediatric pulse oximeters for outpatient child pneumonia care in sub-Saharan Africa

Eric McCollum, MD

Summary

BACKGROUND: Pulse oximeter devices identify hypoxemia by non-invasively measuring the peripheral arterial oxyhemoglobin saturation (SpO2), and are poorly implemented in LMICs, especially for children at primary healthcare clinics (PHCs) in Africa where most cases present. GAP: This study will comprehensively address the root causes of poor pulse oximeter implementation for children at PHCs including: (1) lack of affordable, quality pulse oximeters designed for children in LMICs, a population and setting with specific needs; (2) absence of real-world, high quality clinical trial evidence to inform policies; (3) scarcity of PHC hypoxemia burden and outcome data to motivate pulse oximeter investment. HYPOTHESIS: We hypothesize PHC-identified hypoxemia will be common and associated with an elevated risk ratio for death among African children. We also hypothesize the LB-01 and Phefumla devices will meet accuracy thresholds and LMIC healthcare workers using these devices will correctly manage a higher proportion of children at PHCs with suspected pneumonia than with a standard pulse oximeter. METHODS: The overall design is a cluster randomized controlled trial with a nested prospective cohort and parallel cross-sectional device accuracy sub-study. Trial and cohort participants are children below age five years old with cough and/or difficult breathing at PHCs in a community in Cape Town, South Africa, and device accuracy participants are those having arterial blood gas measurements obtained during routine care at a South African referral hospital. RESULTS: Pulse oximetry accuracy testing is in progress from February 2024, and the cluster randomized controlled trial and nested prospective cohort is expected to start later in 2024. IMPACT: Dissemination of these findings to policy makers in sub-Saharan Africa and at global levels will help to facilitate evidence-based health system investment decisions for African children and help to motivate the development and production of pulse oximeters for pediatric care in LMICs. Website Link: https://www.hopkinsmedicine.org/johns-hopkins-childrens-center/what-we-treat/specialties/pulmonary-medicine/#:~:text=The%20goal%20of%20the%20Global,South%20Africa%2C%20Malawi%20and%20Bangladesh.