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INtegrating Functional Assessment measures for Neonatal Safeguard

Periodic Reporting for period 2 - INFANS (INtegrating Functional Assessment measures for Neonatal Safeguard)

Reporting period: 2021-01-01 to 2023-12-31

"INFANS - INtegrating Functional Assessment measures for Neonatal Safeguard" is a part of the Marie Skłodowska-Curie Innovative Training Network funded by the European Union’s Horizon 2020 Research and Innovation Programme (H2020-MSCA-ITN-2018 number 813483).

The goal of INFANS is to develop a new neonatal brain monitoring, designed to overcome the severe shortage of clinically viable means to high quality monitor the brain function in infancy, crucial to prevent later life neurological, cognitive and motor impairment. To accomplish this goal, INFANS established a structured European PhD training programme in biomedical engineering, signal processing and clinical procedures to train a new generation of creative and entrepreneurial young researchers.

The individual research projects of the ESR encompass the topics technological innovation, industrial development, clinical validation, identification of neonatal healthcare needs. As part of their research the INFANS ESRs will develop a novel platform for high quality, clinically-viable EEG-NIRS monitoring accessible worldwide. Well-targeted visits and secondments, soft skills and dynamic training activities, an Open Science strategy, extensive involvement of ESRs in the network events organization, extensive contacts with other research, training and industrial European networks, dissemination activities and the award of Double doctoral degrees are further assets offered to INFANS ESRs.
To develop a novel platform for high quality, clinically viable EEG-NIRS neonatal brain monitoring. Three main scientific objectives are going to be achieved in hardware development, software development and clinical validation. Regarding the hardware, a first design of a soft electrode with a pin shape based on existing dry electrodes for adults and a first prototype with low hardness materials were built for acquiring the neonatal EEG. Based on the adult Brite system ( a prototype of novel LED based optodes with optimized design for the fragile skin and skull of neonates has been built for NIRS measurements. Both sensor types should be integrated into a novel compliant cap, where two initial compliant neonatal cap prototypes with regular and irregular unit cells were 3D printed. The flexibility of the caps was further optimized by iterative optimizations considering the different properties of the structure in order to get a convenient cap that fits varying head circumferences of neonates. Hardware and software will be integrated in an intuitive monitoring system with a graphical user interface (GUI), where the focus lies on user-friendliness. According to the clinical requirements, a first GUI was built. Further, a way of integrating external algorithms into EEG/NIRS monitoring system was designed. The monitoring system will contain pre-processing and analytical analysis software to process and evaluate the acquired EEG and NIRS data. The first version of a software toolbox contains a novel spatial harmonic decomposition toolbox for data processing, e.g. the removal of artefacts or the extraction of features of interest for the pediatrician. An automated detection of both the electrophysiological and the pulsatile cardiac interference in neonatal EEG signals was implemented based on the fingerprint method, and an automated pre-pre-processing of neonatal EEG to remove flat line and large amplitude activity was developed. A software package to assess neonatal brain dynamics through microstate analysis was also implemented and will be further developed to integrate functional connectivity and graph metrics for short-term analysis of the neonatal EEG. For the NIRS measurement, a Signal Quality Index (SQI) algorithm was developed. The ongoing integration of hardware and software components driven by the joint work of the Early Stage Researchers will allow the clinical testing in the future.
For the first time, a neonatal brain monitoring system is developed which allows for the simultaneous measurement of EEG and NIRS. For that purpose, dry electrodes and optodes especially designed for neonates are combined with a novel modular compliant cap that will allow short-term and long-term monitoring of preterm and term neonates. The intuitive monitoring system that contains software for data processing and evaluation, especially developed with the focus on neonatal EEG and NIRS signals, will allow an integration into clinical practice, where finally the neonates should benefit from the novel minimal disturbing monitoring possibilities allowing for early intervention. The developed novel platform will contribute to a socio-economic benefit in a socio-economic sense due to better diagnosis and monitoring of the neonatal brain in order to eliminate remaining preventable preterm deaths, focusing on equitable care for all and quality of care to minimize long-term impairment.