Clinical Evaluation of Pediatric Pulse Oximeters in South Africa: Protocol for a Cluster Randomized Controlled Trial

BACKGROUND: The burden of children with lower respiratory infections and low blood oxygen levels (hypoxemia) is high and outcomes are poor in low-and-middle-income countries (LMICs). Pulse oximeters non-invasively measure the capillary oxyhemoglobin saturation (SpO2) to identify hypoxemia, but high-quality devices designed for the unique needs of children are rarely available in primary healthcare clinics (PHCs) in LMICs where children initially access care. OBJECTIVE: To evaluate whether two pediatric pulse oximeters co-designed with healthcare workers (HCWs) in LMICs, compared to a standard pulse oximeter, improve the correct SpO2 management of children in PHCs. METHODS: We are conducting a pragmatic three-arm cluster randomized controlled trial in the Eastern Khayelitsha, Northern, and Tygerberg areas of Cape Town, South Africa, over 18 months between 2024-2026. We plan to enroll 1,200