Award Title: NeWTS: Neonatal Wireless Transmission System for Monitoring in Intensive Care
Funder: Department of Health and Social Care

Abstract: 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

Lay Abstract: The need for a wireless monitoring system was highlighted by the frustrations of a father, whose daughter spent her first three months in a Neonatal Intensive Care Unit (NICU). He found all the wires made it difficult to interact, and care for his child.  When babies are in intensive care, they need to be continuously monitored, including measurement of their heart rate and oxygen levels. This requires multiple sensors with separate wires. These wires can become tangled and create both a physical and emotional barrier to care. They make nursing staff less keen to take babies out of the incubators for parents to hold. The holding of babies has been shown to reduce parental anxiety and stress, and to improve brain development for babies. The multiple wires can be overwhelming to parents and make them frightened of holding their small babies. Removing the wires from the monitoring equipment could:    reduce practical barriers for parents providing care, and save nursing time.  increase the opportunities for parents to hold their baby,  increase breastfeeding rates and reduce length-of-stay.  save the NHS money by improving short- and long-term outcomes.      Working with parents and staff at Cambridge University Hospitals NHS Trust (CUH), we have designed, developed, and tested a prototype for a wireless system that connects the sensors to the bedside monitor. This prototype includes wireless monitoring of all three key elements of intensive care monitoring:    skin temperature,  heart activity (electrocardiogram, ECG),  oxygen levels in the blood (pulse oximetry).      This funding would allow development of the prototype into a system to meet manufacturing and regulatory standards so that it can obtain the approval required for clinical use.  This work will require four workstreams:    Design the final system taking into account the technical challenges, user needs (including staff and parents), commercial viability, and commercial manufacturing standards.  Create a business that can ensure the new system reaches patients in the NHS.  Test the new system with babies in intensive care to make sure it is user-friendly, reliable, and safe.  Develop a model to examine the cost and effects of the wireless monitoring compared to current care.      The project is being led by a paediatrician, two academic engineers, two health economists, and a parent representative. The project also needs input from experts in design for manufacturing. We are working with Team Consulting who have significant expertise and experience in developing medical devices, and will ensure the final system is competitive for business. A Project Advisory Board made up of parents, clinical staff, and hospital management will advise on developments to ensure the project meets the needs of all involved.

Research Activity Codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES;4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health Categories: GENERIC HEALTH RELEVANCE