After the project onset, it was rapidly acknowledged that the changing clinical scenario – where the brain is now monitored by clinical cerebral oximeters and amplitude integrated EEG, and, other changes in infrastructure, as well as the immediate post COVID-19 pandemic shortages of components, led us to deploy risk-mitigation strategies result in the deployment of two different classes of prototypes including the originally planned hybrid high-density optical tomography platform (x2) and three, more complex but more precise and accurate monitoring prototypes. This allowed us to measure a relatively large cohort of infants pre-, intra- and post-surgery as well as a very large cohort of pre-clinical animal models. We were able to demonstrate that hybrid diffuse optics can accurately image NVC in response to auditory stimuli in this complex clinical scenario, characterize spontaneous events of NVC during surgery, relate hemodynamic changes during model heart surgery in animal models to outcome, characterize cerebral autoregulation and, overall, present a new, tri-modal device for the study of neurodevelopment in neurosciences.
The project had multiple fronts; (a) device development, assembly, validation and deployment for in vivo studies along with new methods for standardization, (b) algorithm development for multi-modal tomography, spontaneous NVC coupling, (c) data acquisition from clinical cohorts of infants born with CHD, (d) development , implementation and experimental studies of complex heart surgery in piglet models, (e) studies of markets, development of exploitation plans, and (f) dissemination of project results. We have (within the submitted and approved amendments) achieved all the main project goals, updating them as needed to meet the new realities that emerged as is the case with such clinical scenarios and explored new scientific concepts as they arose.
