JMIR Publications

ABSTRACT

Background:

The burden of young children with lower respiratory infections and low blood oxygen levels (hypoxemia) is high and outcomes are generally poor, especially in low-and-middle-income countries (LMICs). Pulse oximeter devices 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 children <2-years-old with an acute respiratory infection from 18 PHCs randomized to implement one of three pulse oximeters, either one standard of care device or two intervention devices. HCWs working in eligible and selected PHCs will administer the trial intervention. Our primary outcome will be ‘correct SpO2 management,’ defined as (1) a HCW-documented SpO2 and heart rate measured in room air, (2) an appropriate referral recommendation provided by the HCW, and (3) a SpO2 confirmed by a successful study staff measurement with reference device that is within a 2% SpO2 range above or below the HCW documented SpO2. A concurrent mixed methods process evaluation will explore how, why, for whom, and to what extent these pediatric pulse oximetry devices impact the clinical management of hypoxemic children. The primary analysis will be an intention to treat analysis, and for all primary and secondary outcomes, we will conduct pairwise comparisons between the two intervention device arms and the control arm.

Results:

The study was funded in 2023 with data collection commencing in late 2024. Results are expected to be published in 2026-2027.

Conclusions:

While there are notable challenges inherent to the design of a trial aiming to evaluate whether pulse oximeters improve HCW SpO2 management of young children accessing care in PHCs, our protocol development process attempted to adequately address all potential limitations and sources of bias with the goal of maximizing the trial’s future impact. Clinical Trial: Clinicaltrials.gov (NCT05914324).