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After a first demonstration phase in laboratory settings, the prototype will be piloted by the NICUs- Neonatal Intensive Care Units - of two public hospitals that are partners in the project: Rigshospitalet of Copenhagen (24 doctors and 120 nurses treat about 1,000 newborns per year); Ospedale Maggiore Policlinico of Milan (22 medical doctors and 60 nurses assist about 600 newborns per year admitted to NICU and special care unit).
The role of the two hospitals is to test the device in different clinical situations:
- the tool will be evaluated under a sufficient range of realistic conditions and disease profiles to be able to assess its applicability fitting as far as possible in the clinical workflow, protocols and procedures, therefore the application in environmental neonatology
- the end-users will not only use the tool, but also proactively drive its definition and the successive implementation from the prototype stage to the demonstrator level. Therefore, in case of positive outcomes of the clinical validation, it is expected an accelerated acceptance and uptake of the device within the BabyLux consortium.
Furthermore, the BabyLux project will address necessary regulatory, safety and standardization issues and provide appropriate ethical and privacy safeguards, with the ultimate goal of bridging the gap for the introduction into the market.