Towards A Premature Fetal Manikin For Model-driven Simulation To Validate Perinatal Life Support Technologies

Background and Aims
Perinatal-Life-Support (PLS) research is progressing to provide extreme premature infants a safe extracorporeal environment for further growth. A crucial step before being accepted into healthcare is the careful validation of life-support technology. However, clinical trials with living subjects yields great ethical concerns and limits testing and training of early-stage concepts. A promising alternative can be found in
manikins, which can resemble infants on an anatomical and even physiological level.


Methods
An analysis was performed defining the design framework for the manikin to function as a validation model for PLS-technologies. A scientific literature review was conducted to identify parameters involved in the physiologic events that need to be prevented when transferring a perinate into a PLS-system, avoiding neonatal transition and maintaining fetal status.


Results
In our proposed framework, output of embedded sensors is compared to parameter threshold values as set in a linked computational model. The manikin’s embedded actuators could display symptoms, serving as a feedback loop during testing and training. The parameters include temperature, lung aeration, liquid clearance of lungs, umbilical cord compression, heart rate, blood pressure and flow. Symptoms include
chest expansion, gasp reflex, cyanosis, vasospasm, and decreased fetal movement. Lastly, based on MRI scans, a 3D manikin prototype was developed that contains space for hardware integration.


Conclusions
The development of a simulation to validate a life-support system, not yet tested on humans, is unprecedented. With the proposed framework and requirements, we expect improved feedback during dimensional testing and training, allowing for design improvements and eventually promote success of future clinical trials.