Development of a Clinical Simulation Protocol for the Transfer of a Premature Fetal Manikin to the Perinatal-Life-Support System

Introduction: At present, Perinatal-Life-Support (PLS) research is progressing to offer extreme premature infants an extracorporeal environment for extended growth that mimics the natural womb closely. During the early phase development of this novel life-support technology, validation and training could be facilitated by the use of a medical simulation. By doing so, the need for animal testing can be greatly reduced. Within this abstract, the development to realize a wellorchestrated clinical simulation protocol is described, tailored to the specific needs of novel procedure(s) regarding the transfer of a premature fetus from the maternal uterus to the PLS system. Materials & Methods: Throughout protocol development an iterative approach is used, initiated with a literature analysis and a review of existing obstetrics guidelines for premature births. Next, co-creation sessions and interviews with medical and engineering experts led to a holistic understanding of fetal physiology, patient and specialist needs, current procedures, task divisions, hospital resources and drug specifications. Expert feedback on drafts, checklists and an explanatory step-by-step video, led to multiple re-designs as unforeseen procedural difficulties arose. Verified with available data from literature, multiple perspectives and options were analyzed and weighed to ensure the advancement of a safe, hygienic, effective, and user-friendly simulation protocol. Results: We describe the development process of a simulation protocol and showcase an overview of the current protocol design through an infographic, outlining the different phases and tasks during a transfer procedure and the planning of involved medical experts within the operating theatre. We demonstrate that an iterative approach to protocol development for an unprecedented procedure allows for a comprehensive understanding of the challenges that a transfer to the PLS-system could bring. Conclusions: Using medical simulation during the early phase development process of the PLS-system allows us to train and validate novel practices, in particular the transfer procedure. With the demonstrated approach we aim to establish a thorough simulation protocol by providing a step-by-step plan, informed by literature and expert consultation. We expect to offer a realistic simulation training whilst also informing requirements for the future development of PLS-related devices and their validation