Clinical Evaluation of a Wireless Device for Monitoring Vitals in Newborn Babies

To evaluate the ability of the Nemocare Raksha (NR), an internet of things (IoT)-enabled device, to continuously monitor vitals for 6 h and its safety in newborns. The accuracy of the device was also compared with the readings from the standard device used in the pediatric ward.

Forty neonates (either gender) weighing ≥ 1.5 kg were included in the study. Heart rate, respiratory rate, body temperature, and oxygen saturation was measured using the NR and compared with standard care devices. Safety was assessed by monitoring for skin changes and local rise in temperature. The neonatal infant pain scale (NIPS) was used to assess pain and discomfort.

A total of 227 h of observations (5.67 h per baby) were obtained. No discomfort or device-related adverse events were noted during the study period. The mean difference between the NR and the standard monitoring was 0.66 (0.42 to 0.90) for temperature (°C); -6.57 (-8.66 to -4.47) for heart rate (bpm); 7.60 (6.52 to 8.68) for respiratory rate (breaths per minute); -0.79 (-1.10 to -0.48) for oxygen saturation (%). The level of agreement analyzed using the intraclass correlation coefficient (ICC) was good for heart rate [ICC 0.77 (0.72 to 0.82); p value < 0.001] and oxygen saturation [ICC 0.80 (0.75 to 0.84); p value < 0.001]; moderate for body temperature [ICC 0.54 (0.36 to 0.60); p value < 0.001] and poor for respiratory rate [ICC 0.30 (0.10 to 0.44); p value 0.002].

The NR was able to seamlessly monitor vital parameters in neonates without any safety concern. The device showed a good level of agreement for heart rate and oxygen saturation among the four parameters measured.