Periodic Reporting for period 1 - Prometeus (Preterm Brain-Oxygenation and Metabolic EU-Sensing: Feed the Brain)
Periodo di rendicontazione: 2023-02-01 al 2024-01-31
Prometeus introduces a new-paradigm for personalized nutrition of prematurely born neonates in neonatal intensive care unit (NICU), by developing a groundbreaking technology for real-time adjustment of glucose and nutrients intakes to target neonatal brain needs. The brain of a baby born prematurely is highly susceptible to early neonatal injuries that, in turn, increase the risk for neurodevelopmental disability. Provision of adequate nutrients and oxygen is essential for proper brain development and growth. However, current nutritional strategies are unfit to target real-time brain necessities, and are driven by pre-specified (non personalised) nutritional charts, in the absence of contemporary cot-side monitoring of both brain “health” and metabolic supplies. As a consequence, sudden changes of brain fuel-requirements cannot be promptly addressed by real-time adjustment of glucose and nutrients provision. Prometeus will develop a metabolic model of the interaction between the three key brain fuels [glucose, lactate and beta-hydroxybutyrate (BHB)] and their effect on regional cerebral blood flow (CBF), oxygen saturation (StO2) and metabolism (CMRO2). The model will serve to individualize brain nutrition targeting “brain health” according to the inputs derived from two novel minimally invasive metabolic sensing systems: a wearable cap measuring regional CBF, StO2 and CMRO2 (neo-opticap) and a subcutaneous miniaturized metabolic sensor for glucose, lactate and BHB (CMM). The system will create a metabolic “womb” to feed the brain of preterm neonates. Prometeus will be paralleled by a parent-dedicated interface, exploiting a purposely developed family adjusted visual language, that will inform parents of preterm babies during their NICU admission and stay. Prometeus groundbreaking technology will be advised by a feed-forward interaction with families of preterms and health care personnel to shape the new device aiming at incorporating the needs of the final users. This approach will create a novel paradigm for the industrial development of neonatal devices along with an archive for the future scientists and historians of infancy. Prometeus will dramatically reduce the risk for prematurity-associated disability in Europe and worldwide, with a consequent incalculable ethical, social and economic impact.
During the first year of the project, we started to develop the neo-opticap and CMM. In particular, a first protype of the neo-opticap probe layout has been developed. All the technical specifications have been defined and according to them, the hardware modules are now being developed.
The development of the miniaturized on-body patch sensor for the minimally invasive continuous monitoring of the three key brain metabolites: glucose, lactate and beta-hydroxybutyrate (BHB) (CMM) is under development as well. Currently, an adhesive able to provide up to 14 days wearing time with minimal skin irritability has been identified and the biocompatibility of the patch and microprobe chip components verified in an animal model.
The first steps towards developing the metabolic neonatal model, and consequently, the algorithm to provide personalized nutrition to target brain health, have been taken, by planning and optimizing the animal experiments, which will provide the first data for the model.
The development of the Prometeus Cloud-based environment for handling, in the neonatal intensive care unit, the on-body monitoring system developed during Prometeus is under development as well. So far, a first prototype is available, which consists of the Prometeus Edge Unit, a field device that interoperates with neo-opticap and CMM and handle the individual nutritional information provided by the above-mentioned algorithm, and the Prometeus Cloud Service, a cloud platform that manages the Prometeus Edge Unit and collects and back-up the data.
Finally, the assessment tool that will be used to evaluate the impact of on-body monitoring devices on parents and health care personnel and their experience with preterm neonates is almost completed. The script that will be used in the interview of parents and health care personnel for the creation of the first Visual and Oral Archive of prematurity is under development.
The development of the miniaturized on-body patch sensor for the minimally invasive continuous monitoring of the three key brain metabolites: glucose, lactate and beta-hydroxybutyrate (BHB) (CMM) is under development as well. Currently, an adhesive able to provide up to 14 days wearing time with minimal skin irritability has been identified and the biocompatibility of the patch and microprobe chip components verified in an animal model.
The first steps towards developing the metabolic neonatal model, and consequently, the algorithm to provide personalized nutrition to target brain health, have been taken, by planning and optimizing the animal experiments, which will provide the first data for the model.
The development of the Prometeus Cloud-based environment for handling, in the neonatal intensive care unit, the on-body monitoring system developed during Prometeus is under development as well. So far, a first prototype is available, which consists of the Prometeus Edge Unit, a field device that interoperates with neo-opticap and CMM and handle the individual nutritional information provided by the above-mentioned algorithm, and the Prometeus Cloud Service, a cloud platform that manages the Prometeus Edge Unit and collects and back-up the data.
Finally, the assessment tool that will be used to evaluate the impact of on-body monitoring devices on parents and health care personnel and their experience with preterm neonates is almost completed. The script that will be used in the interview of parents and health care personnel for the creation of the first Visual and Oral Archive of prematurity is under development.
Given the very early phase of the project, only few results are currently available that could have high scientific, technologic, business or economic potential. In particular, some improvements in the hardware and modeling obtained during the development of neo-opticap and the results of the preclinical proof of concept study that demonstrated for the first time the safe and effective skin introduction of silicon microprobes during CMM development, might have future potential market distribution.