The Unit employs advanced monitoring and diagnostic technologies to support its research activities, including:
Video EEG for continuous assessment of brain activity and seizure detection;
CFM (amplitude-integrated EEG) for bedside cerebral monitoring;
NIRS (near-infrared spectroscopy) to evaluate cerebral and systemic oxygenation;
Ultrasound for real-time and bedside evaluation of cerebral structure and cardiac assesment
Pressure Recording Analytical Method (PRAM) is going to be adopted to enable hemodynamic monitoring and detailed assessment of cardiovascular function of neonates
The Unit joins the EVENEW Study, that is the first mesenchymal stromal cell (MSC)-derived extracellular vesicles (EXOB-001) trial approved by the EMA
EVENEW is a multicenter, adaptive, seamless Phase 1/2 clinical trial designed to evaluate the safety and efficacy of intratracheal administration of EXOB-001 for the prevention of bronchopulmonary dysplasia (BPD) in preterm newborns.Phase 1 is a single-arm, dose-escalation study aimed at assessing the safety of intratracheal EXOB-001 administration. This phase is enriched with a nested historical case–control cohort to enable comparative evaluation of clinical outcomes.Following a positive interim analysis, the study transitions seamlessly to Phase 2, a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy of EXOB-001 in reducing the severity grade of BPD.Enrolled patients will be followed longitudinally up to a corrected age of two years to assess both respiratory and longer-term clinical outcomes.
