Abstract
Objectives
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.
Method
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.
Result
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].
Conclusion
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.
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Acknowledgements
The authors thank the parents for consenting to the participation of their babies in this study. They acknowledge the staff of the Clinical Research Department, Sister Punitha Rani, and Ms. Madhu Rudra for helping in the data collection. The authors sincerely thank Dr Alben Sigamani, the former head of the Clinical Research Department, Narayana Hrudayalaya, Bangalore for his suggestions during the designing stage of the study and TBI-MSMF.
Funding
The study was supported by a BIRAC grant (BIRAC/IKP0806/BIG-13/18) to Manoj Sanker.
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RA recruited subjects for the study and performed the final review for the manuscript; VG designed the study and prepared the initial draft of the manuscript; DM analyzed the data; MS and SP provided training on the investigational device, reviewed the manuscript, and provided inputs. The final manuscript was reviewed by all the authors. RA will act as the guarantor for this paper.
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MS and SP are employees of Nemocare Wellness Pvt. Ltd. and were not involved in the designing, conduct of the study, and final analysis of data. However, the final manuscript was reviewed by both MS and SP.
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Aggarwal, R., Gunaseelan, V., Manual, D. et al. Clinical Evaluation of a Wireless Device for Monitoring Vitals in Newborn Babies. Indian J Pediatr 90, 1110–1115 (2023). https://doi.org/10.1007/s12098-022-04459-8
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DOI: https://doi.org/10.1007/s12098-022-04459-8