Rao Suman, Thankachan Prashanth, Amrutur Bharadwaj, Washington Maryann, Mony Prem K
1Department of Neonatology, St John's Medical College Hospital, St John's National Academy of Health Sciences, Bangalore, 560034 India.
2Division of Epidemiology and Population Health, St John's Research Institute, St John's National Academy of Health Sciences, Bangalore, 560034 India.
Pilot Feasibility Stud. 2018 May 21;4:99. doi: 10.1186/s40814-018-0293-5. eCollection 2018.
Remote biomonitoring of vital parameters in hospitals and homes has the potential to improve coverage and quality of maternal and neonatal health. Wearable sensors coupled with modern information and communication technology now offer an opportunity to monitor temperatures and kangaroo mother care (KMC) adherence in a continuous and real-time manner remotely for several days' duration in hospital and home settings. Using an innovative remote biomonitoring device to measure both temperature and baby position, we undertook a techno-feasibility study in preparation for a clinical trial.
We designed and developed a wearable sensor for tracking KMC adherence and neonatal temperature, using social innovation design principles. After screening mother-infant dyads using clinical and logistic eligibility criteria, we piloted this wearable sensor along with a gateway device and the commercial cellular network. The dyads were recruited during hospitalization and followed up in the hospital and home phases for several days. Simple descriptive statistical analysis was undertaken.
Recruitment rate was 50% (6/12), and consenting rate was 83% (5/6) during a 2-month period. These five neonates contributed a total of 39 study days (15 hospital days and 24 home days). Their mean [± standard deviation (S.D.)] birth weight was 1490 (± 244) g.The mean (± S.D.) of the vital signs for the five babies was temperature [36.5 °C (± 0.3)], heart rate [146.5/min (± 14)], and oxygen saturation [94% (± 4)]. No severe or moderate side-effects were noted; one baby developed mild dermatitis under the device that was transient and self-limiting, yielding an incidence proportion of 20% and incidence rate of 2.6/100 person-days.None of the mothers reported any discomfort with the use of the device. Temperatures detected from 81 paired readings revealed that those from the wearable sensor were 0.2 °C lower than those detected by clinical thermometers [36.4 (± 0.7) 36.6 (± 0.3); < 0.001].There was also iterative feedback that was useful for hardware and software design specifications of the wearable sensor, the gateway device, and the analytics platform. Lastly, lessons were learnt with regard to the logistics of research team interactions with healthcare professionals and study participants during the hospitalization and post-discharge home phases of the study.
The pilot study has shown that it is feasible and acceptable to track KMC adherence as well as maternal and newborn temperatures in a potentially safe manner on a real-time mode for several days' duration during hospitalization and home phases. The pilot has also helped inform modifications in clinical monitoring, technological modifications, and logistics planning in preparation for the definitive clinical trial.
Clinical Trials Registry of India, CTRI/2017/09/009789.
对医院和家庭中的生命体征进行远程生物监测，有可能改善孕产妇和新生儿健康的覆盖范围和质量。可穿戴传感器与现代信息通信技术相结合，为在医院和家庭环境中连续、实时地远程监测体温和袋鼠式护理（KMC）依从性提供了机会，监测时长可达数天。我们使用一种创新的远程生物监测设备来测量体温和婴儿位置，开展了一项技术可行性研究，为临床试验做准备。
我们运用社会创新设计原则，设计并开发了一种用于追踪KMC依从性和新生儿体温的可穿戴传感器。在使用临床和后勤纳入标准对母婴二元组进行筛选后，我们对该可穿戴传感器以及一个网关设备和商业蜂窝网络进行了试点。这些二元组在住院期间招募，并在医院和家庭阶段进行了数天的随访。进行了简单的描述性统计分析。
在为期2个月的时间里，招募率为50%（6/12），同意率为83%（5/6）。这5名新生儿共贡献了39个研究日（15个住院日和24个家庭日）。他们的平均（±标准差）出生体重为1490（±244）克。这5名婴儿生命体征的平均（±标准差）为体温[36.5℃（±0.3）]、心率[146.5次/分钟（±14）]和血氧饱和度[94%（±4）]。未观察到严重或中度副作用；1名婴儿在设备下方出现轻度皮炎，为一过性且可自愈，发生率为20%，发病率为2.6/100人日。没有母亲报告使用该设备有任何不适。从81对配对读数中检测到的体温显示，可穿戴传感器检测到的体温比临床体温计检测到的体温低0.2℃[36.4（±0.7）对36.6（±0.3）；<0.001]。还获得了迭代反馈，这对可穿戴传感器、网关设备和分析平台的硬件和软件设计规范很有用。最后，在研究的住院和出院后家庭阶段，就研究团队与医护人员及研究参与者互动的后勤工作吸取了经验教训。
初步研究表明，在住院和家庭阶段以潜在安全的方式实时追踪KMC依从性以及母婴体温达数天是可行且可接受的。该初步研究还为准备确定性临床试验时临床监测的调整、技术改进和后勤规划提供了参考。
印度临床试验注册中心，CTRI/2017/09/009789。
