A wireless monitoring system for babies in intensive care is about to move from a working prototype to a commercial medical device, replacing the tangle of wires that currently limits physical contact between parents and their preterm infants. The problem is concrete: wired sensors create physical and psychological barriers to care. Preterm infants can spend months in hospital with fragile skin, and parents report that wires limit their ability to hold and comfort their baby. Increasing skin-to-skin contact has been shown to improve breastfeeding rates, shorten hospital stays, and boost neurodevelopmental outcomes. The system, called NeWTS, uses a wireless bridge to transmit data from temperature, ECG, and pulse oximetry sensors to the patient monitor, and has already been tested with 30 babies. If successful, the device could reduce the roughly one million annual days of neonatal intensive care in the NHS, which cost around £800 million in 2018/19. For families, it means fewer barriers to holding their child. For staff, it saves time spent managing wires. The project will also develop a health economic model to support a future trial of cost-effectiveness and a pathway to NHS adoption.
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Aim To transform a proof-of-concept wireless vital sign monitoring system designed for use with infants in intensive care into a commercial product. Background Neonatal intensive care (NICU) combines monitoring of vital signs with addressing the developmental and psychological needs of babies and their parents. This is challenging for preterm infants who are extremely small and vulnerable, with fragile skin and who may be in hospital for many months. Parents and staff frequently report that wired sensors create both physical and psychological barriers to care, and limit physical contact. Increasing physical contact has been shown to increase breastfeeding rates, reduce length of stay, and improve neurodevelopmental outcomes. Therefore, the introduction of wireless monitoring could result in savings for the NHS, with a reduction in the one million annual days of NICU, which cost the NHS approximately £800 million in 2018/19. No currently available devices address the unique requirements of babies in NICU. We have designed NeWTS, a novel and bespoke wireless bridge between vital sign sensors and the patient monitor. Our prototype system includes three separate sensor modules (temperature, 3-lead electrocardiogram, and pulse oximetry). This has been successfully tested with 30 babies in NICU Objectives 1. Design review and redevelopment within a quality management system suitable for regulatory approval, with a view to manufacture at volume. 2. Validate the new system by bench testing and a clinical study within the NICU, with data collection relating to reliability, safety, and utility of the system. 3. Develop a health economic model and establish the framework for data collection to inform a future trial of effectiveness and cost-effectiveness. 4. Develop a commercial pathway for regulatory approval and adoption into the NHS. Methods We are working with Team Consulting who are a specialist medical devices consultancy and will undertake the system development which will require four design phases: Requirements and concept Preliminary design Detailed design and batch production Design verification The production prototype will undergo bench testing as well as a single-centre feasibility study (months 16-30). This small study (n=30) will evaluate the reliability, utility, and safety in clinical practice. Infants will have wired monitoring replaced by wireless monitoring from recruitment until discharge, with a primary outcome of frequency of skin-to-skin contact. A decision model of the costs, effects, and utility of the wireless system will be developed to give estimates of cost-effectiveness, influence study design of future clinical trials, and provide evidence for NICE. With support from our wide ranging network, we will develop a sustainable business strategy and establish the optimal route to market. Anticipated Impact At a patient level, NeWTS improves quality of care, reducing barriers between babies and their parents. This will reduce parental anxiety and improve infant's physiological stability, and has the potential to increase breastfeeding rates and reduce length of stay. Impacts for staff include time saved in providing clinical care. Wireless monitoring could therefore be cost saving for the NHS as well as improving quality of care and addressing the drive to improve family-centred care
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