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

Abstract

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 0.059C (range: -0.035C to 0.195C) 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 -0.04C (95% CI -0.52C to 0.44C). 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.