Every year, around 800 UK newborns with moderate to severe brain injuries are tethered to bulky monitoring machines in intensive care, separated from their mothers for days. This matters because the current method for diagnosing and managing brain injury in newborns—amplitude integrated electroencephalogram (aEEG)—requires admission to a neonatal intensive care unit (NICU). That separation disrupts bonding and breastfeeding, and adds roughly two to three days to a baby’s hospital stay, costing the NHS about £1,682 per day. Many babies do not need intensive care, but no compact wireless device exists to let them be monitored remotely while staying with their mothers. If this project succeeds, a stick-on wireless EEG device smaller than a fingernail—developed with the company Huru—could replace the bulky needle-electrode systems. Babies could be monitored continuously for up to four days via Bluetooth, with data viewable on a tablet, while remaining in their mother’s arms. That would allow early diagnosis and severity assessment of hypoxic-ischaemic encephalopathy without separating families, and could even enable skin-to-skin contact during cooling therapy. The device is already validated in adults and on track for regulatory approval in 2025–2026.
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Health problem This application addresses the diagnosis, management and stratification of severity of brain injury in newborn babies. About 6/1000 liveborn babies acquire brain injuries1 that are diagnosed and managed using a simplified brain activity monitoring called amplitude integrated electroencephalogram (aEEG) using cerebral function monitors.2 In the UK, around 2000 asphyxiated babies undergo aEEG monitoring each year for a minimum of 6 hours after birth to diagnose brain injury called hypoxic-ischaemic encephalopathy (HIE) and stratify the severity of HIE.3 4 Of these, 800 babies develop moderate to severe HIE and receive cooling therapy and aEEG monitoring using needle electrodes for three days.3 Of the remaining asphyxiated babies, about 600 develop mild HIE and others may not develop HIE. Currently, aEEG monitoring requires admission to neonatal intensive care units (NICU), which separates babies from their mothers and disrupts bonding.5-8 NICU-based aEEG monitoring prolongs babies hospital stay by around 2-3 days, because of delay in establishing breastfeeding, costing NHS around £1682/ day.9 Many babies do not need intensive care and hence could have remote aEEG monitoring with their mothers, but the lack of compact wireless aEEG devices prevents this. Further, parents and neonatal staff are concerned about the impact of early separation of mother and babies on bonding and breastfeeding.10 There is an urgent need for remote aEEG monitoring for early diagnosis, stratification and management of HIE whilst promoting parent infant bonding and enabling parent-baby contact during cooling therapy (e.g., CoolCuddle) without the risk of injury from needle EEG electrodes.8 Innovation Our collaboration with Huru will address this need through the Clic EEG monitoring device. This compact, wireless EEG system features a single easy to apply stick-on interface placed on the newborn s scalp, enabling brain activity monitoring via Bluetooth without disrupting parent-infant interaction. The device is lightweight, measuring only 29mm x 14mm x 7mm and weighing less than 6 grams, making it much smaller and more portable than standard CFM systems. Clic EEG can record continuously for up to four days, with data viewable in real-time on a tablet. Its low noise input (1 µVpp) surpasses that of typical aEEG devices, ensuring high-quality signal transmission. While the current Clic EEG version provides raw and processed EEG signals, further development through this project will allow these to be converted into aEEG, the required format for diagnosing brain injury in newborns. Innovation Stage Clic EEG is on track for Class 2 regulatory approval as an ambulatory EEG device in the US in 2025, and UKCA approval in 2026. It complies with key standards such as IEC 80601-2-29 and ISO 13485, with hardware reaching Technology Readiness Level (TRL) 7. The software for EEG-to-aEEG conversion is currently at TRL 4, with plans to reach TRL 7 by project completion. Evidence Generated Clic EEG has been validated in lab and clinical settings, including over 1,500 hours of data collection from patients, though none under the age of four. Its compliance with EEG equipment standards and low noise input supports its use in newborn monitoring.
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