Evaluation of a continuous neonatal temperature monitor for low-resource settings: a device feasibility pilot study.

Objective: Evaluate a novel continuous temperature monitor in a low-resource neonatal ward.

Design: We developed a low-cost continuous neonatal temperature monitor (NTM) for use in low-resource settings. Accuracy of NTM was initially assessed in the laboratory. Clinical evaluation then was performed in a neonatal ward in a central hospital in Malawi; eligible neonates (<1 week of age) were recruited for continuous temperature monitoring with NTM and a Philips Intellivue MP30 Patient Monitor.

Interventions And Outcome Measures: The temperature probes of NTM and the reference patient monitor were attached to the infant's abdomen, and core temperature was continuously recorded for up to 3 hours. Axillary temperatures were taken every hour. We compared temperatures measured using NTM, the patient monitor and the axillary thermometer.

Results: Laboratory temperature measurements obtained with NTM were within 0.059°C (range: -0.035°C to 0.195°C) of a reference thermometer. A total of 39 patients were recruited to participate in the clinical evaluation of NTM; data from four patients were excluded due to faulty hardware connections. The mean difference in measured temperatures between the NTM and the Intellivue MP30 was -0.04°C (95% CI -0.52°C to 0.44°C).

Conclusion: NTM meets ISO 80601-2-56 standards for accuracy and is an appropriate, low-cost continuous temperature monitor for neonatal wards in low-resource settings.

Trial Registration Numbers: NCT03965312 and NCT03866122.