Perinatal Life Support System: Integration of Enabling Technologies for Clinical Translation

Every year, 800.000 babies are born extremely preterm (EP; <28 weeks of age) worldwide. A large proportion of survivors from this group of smallest infants face lifelong disabilities, including breathing, cardiac, neurological and metabolic problems. Current treatment requires the preterm initiation of body functions for which the respective organs are not prepared. This affects primarily the lungs which need to provide gas-exchange under air (i.e. oxygen-based mechanical ventilation), and the gut, which is needed for energy and nutrition. This approach causes major therapy-related morbidity such as bronchopulmonary dysplasia, necrotizing enterocolitis and germinal matrix bleeding. The Perinatal Life Support (PLS) consortium envisions a medical device that can support the safe development of EP infants outside the womb by preserving the innate fetal cardiorespiratory physiology ex vivo, with the following enabling technologies: 1. A liquid-based environment with oxygen and nutrient exchange using an ´artificial placenta´; 2. Continuous and non-invasive monitoring of fetal parameters such as heart rate and oxygenation; 3. Computational models for fast and objective clinical decision support based on physiological data input; 4. A fetal manikin that can accurately simulate EP infants in an intensive care setting. The PLS project will be carried out by an interdisciplinary group of academia and industry with experience in modelling, monitoring, engineering, obstetrics and neonatology. The technology underlying PLS is applicable to conditions where ex vivo life support is required e.g. organ perfusion, regeneration and transplantation. The integrated system will allow major progress towards translation for an urgent medical need, where new solutions are lacking as preclinical models are inadequate and clinical trials not feasible. Innovative simulation technology will enable technical validation of PLS, with demonstration of functionality in a final Proof-of-Principle.