Neonatal EEG Monitor (NEMO)



 DESCRIPTION (provided by applicant): Neonatal seizures are a common neurologic diagnosis in the Neonatal Intensive Care Unit (NICU), occurring in some 14,000 newborns annually in the US, and are frequently associated with long-term deleterious consequences including intellectual disability, cerebral palsy, epilepsy, and other neurodevelopmental disabilities. Early detection and treatment can result in more effective seizure control and decreased rates of epilepsy and may also lead to reduced morbidity and mortality after neonatal seizures. The only reliable means of detecting and treating neonatal seizures is EEG recording. However, many NICUs do not have the capability to conduct an EEG recording, principally due to a lack of skilled EEG technologists needed to apply EEG conventional wet electrodes to delicate neonatal skin. QUASAR, in collaboration with Children's National Health System (CNHS), proposes to develop an innovative Neonatal EEG MOnitor ("NEMO") system intended as a reliable and easy-to-use EEG system that will increase the availability of neonatal EEG monitoring at all hours of the day and to hospitals that typically lack this capability. NEMO leverages QUASAR's innovative dry sensor technology that has been demonstrated to record high fidelity EEG signals that are immune to electrical artifacts, without the need for skin abrasion or the use of conductive gels. These dry sensors are embedded into a rapidly applied headset that is gentle to neonatal skin and can be applied by nursing staff, leading to more neonates at risk for seizures being quickly screened and appropriately treated, which in turn is expected to shorten hospital stays and improve outcomes. Under the Phase 1 portion of this SBIR, EEG from neonates was successfully recorded in an NICU using prototype dry sensors. The dry sensor EEG signals were comparable to those recorded with wet electrodes and deemed suitable for diagnosis of clinically relevant EEG patterns. These encouraging results are leading us to further pursue the development of NEMO in this Phase 2 proposal. The principal goal of the Phase 2 effort is to develop NEMO to the point of readiness to apply to the FDA for 510(k) premarket approval.