Project Summary/Abstract Minnesota HealthSolutions Corporation (MHS) and Children’s Hospital Los Angeles (CHLA) propose the development and validation of a novel system for creating custom-fit respiratory interface appliances for the purpose of improving non-invasive ventilation (NIV) for infants and children in the intensive care unit (ICU). Technology advancements in NIV have improved outcomes for critically ill patients, but unfortunately, most neonates and children do not achieve the full benefits of NIV, particularly bi-level ventilation, because they are unable to effectively synchronize breaths with the non-invasive ventilator. This is because pediatric NIV patient interface appliances often have significant air leakage, which, when combined with the fact that children generate smaller changes in airway flow, prevents the ventilator from reliably sensing patient effort. The resulting ventilator breaths are asynchronous with patient effort, leading to ineffective ventilation, higher patient effort of breathing, and worsening lung injury. To overcome excessive leakage and inadequate triggering, clinicians often tighten interfaces, resulting in skin breakdown and pressure ulcers. NIV related pressure ulcers are becoming amongst the most common complications in intensive care units. The lack of effective NIV leads to higher rates of intubation in neonates and young children, with unnecessary exposure to medications which harm the developing mind, longer ICU lengths of stay, and iatrogenic complications such as infection, ventilator induced diaphragm dysfunction, and post-ICU impairment in quality of life. Ventilator manufacturers are searching for solutions to this problem because many previously developed products have not gained widescale commercial use since they are invasive or have substantial technical limitations when applied to the infant or neonate. The proposed project will develop and evaluate an innovative system for rapid in-hospital production of custom-fit NIV respiratory interfaces.