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 0.059°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.

Keywords: intensive care; neonatology; paediatric practice.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1

NTM is composed of three major components: (1) a temperature probe, (2) a reusable belt and (3) a monitor. The temperature probe is held over the liver by a belt with shoulder strap. The monitor displays the infant’s core temperature in °C with visual indicators corresponding to hypothermia, normothermia and hyperthermia. The reusable temperature probe snaps into the belt. NTM, neonatal temperature monitor.

Figure 2

CONSORT flow diagram. CONSORT, Consolidated Standards of Reporting Trials.

Figure 3

Clinical evaluation setup. During testing, the abdominal belt was placed around the infant, positioning the temperature probe above the liver. A commercial patient monitor (PM) and temperature sensor were used as the gold standard. All data were recorded using logging software. NTM, neonatal temperature monitor.

Figure 4

Top: examples of recorded signals. NTM (solid line) and PM (dashed line) signals were continuously recorded throughout the study. Axillary measurements (black diamonds) were collected every hour. (A) An example showing constant core temperature. (B) An example during nursing. An increase in the subject’s temperature is observed during nursing, shown by both PM and the NTM device. In both recordings, NTM signal was within ±0.5°C (dotted line) of the PM and axillary temperatures. Bottom: Bland-Altman plots comparing the temperatures recorded from (C) NTM and PM, (D) PM and axillary measurement and (E) NTM and axillary measurement. Biases are shown using a dashed line. Ninety-five per cent CI upper and lower limits of agreement (ULOA and LLOA, respectively) are shown using a dotted line. NTM, neonatal temperature monitor; PM, patient monitor.