Development and validation of a multi-parameter sensor for optimal resuscitation of high-risk newborns

Background An estimated 10% of newborns require some form of assistance or resuscitation at birth (about UK=72,000/year and globally=14million/year).

For high-risk infants, such as those born preterm or following birthing difficulties, resuscitation increases their risk of dying or developing life-long disabilities including cerebral palsy. Brain injury at or soon after birth occurs in ~3,500 babies each year in England. Optimal resuscitation practice in the first golden minutes of life can reduce the risk of death and brain injury.

Current evidenced-based international resuscitation guidelines recommend that multiple vital signs are targeted to ensure optimal care, these include heart rate, oxygen saturations and temperature.

These measures require multiple sensors and devices, many of which perform poorly as they were never designed for the unique delivery room environment.

Failure to maintain newborns within these set parameters, along with others such as targeted tidal volume ventilation, increases the risk of death or significant morbidity including brain injury.

Improving newborn monitoring will advance resuscitation practice, reduce death or severe morbidity, and significantly reduce healthcare costs.

Aims/Methods We aim to develop the world s first wireless, multiparameter newborn monitoring system specifically designed for resuscitation at birth – VS Patch.

This system uses a patented non-adhesive, single patch array capable of measuring the core vital signs of heart rate (both electrically and optically), oxygen saturations and temperature. Optional capabilities will include wireless respiratory function monitoring and video recording for training and audit.

The dedicated, single screen user interface displays all these measures, event logs, and is compatible with electronic patient records.

We aim to produce the pre-production prototype, undertake the required regulatory testing (including neonatal studies) and produce a regulatory ready technical file for commercialisation and NHS adoption.

There are no competitor devices available, or under development, that match our system specification and we believe this device will be in the clinic 1-2-years after project completion.

Team/PPI/Dissemination Our established team is led by academic clinicians and engineers with a track record of translating their research into commercially available medical devices.

Partnering with two neonatal device companies, SurePulse Medical and Monivent, provides expertise, a commercial pipeline, distribution networks and hence a route to NHS adoption and wider market uptake.

Importantly, we have excellent PPI/stakeholder engagement embedded within the project to co-design all aspects, provide the parent perspective and share dissemination of outputs.

Our parent co-investigator and parent groups provide diverse input into the project and represent the two largest and highest risk newborn populations who are most likely to benefit from this technology, namely babies born preterm or those with hypoxic-ischaemic encephalopathy.

Impact Our system addresses the top priorities of leading newborn resuscitation clinicians, the James Lind Alliance preterm birth top 10, NHS Long Term Plan and the Better Births initiative to half neonatal deaths and brain injury.

Improving outcomes of high-risk newborns will not only benefit the children and their families, but also potentially save the NHS millions of pounds each year in healthcare (~£2.5Billion alone for preterm birth) and litigation costs (~£2Billion for birth related injury).