The work in the project in the first year has been carried out along the lines described in the work packages and is described in more detail in section 2 of this report. The main results and achievements are summarized here.
In a first stage of the research an overview of the main requirements needed for the PLS system to be ready for clinical application are investigated. An outline of the impact on the work packages is given, and the refinements for which simulations are needed are discussed. The requirements
enlisted are deemed to be necessary for successful execution of the project’s work packages and are either in need of further investigation, or ready to set specifications and conditions for features of the PLS system (D1.1).
1. Computational models for fast and objective clinical decision support based on physiological data input.
In parallel, the purpose, main requirements, and structure of the computational models that will be developed in the PLS project for simulation of the PLS system have been defined (D1.2). The outcome of this activity will serve as a starting point and guideline for further development of the computational model that can be used to optimize the system on the one hand as and form the basis of the decision support system at the other hand.
2. A liquid-based environment with oxygen and nutrient exchange using an artificial placenta.
Regarding the development of a liquid based environment two concepts (liquid filled lungs and liquid filled cavity resp.) have been evaluated and several options for first prototypes have been investigated (D2.3). In addition, the possibilities for cannulation of very small blood vessels with regard to an overview of existing methods and cannulas have been investigated.
3. A fetal manikin that can accurately simulate EP infants in an intensive care setting.
The possibility and feasibility of the design and prototyping technology of fetal manikins based on MRI information for use as a surrogate EP infant and validation tool for performance evaluation of the PLS system (D3.3) as well as the possibility to provide the system with an appropriate transfer device to deliver the fetus (D3.4) have been investigated.
4. An extracorporeal system that serves as an artificial placenta.
The design and development of a small volume, low resistance, membrane oxygenator that oxygenates the blood extracorporeally, and thus takes over the lung function of the placenta and might include a heat exchanger in order to keep the blood at body temperature has been investigated (D4.3). The need for a fetal dialyzer has been evaluated D4.4).
5. Continuous and non-invasive monitoring of fetal parameters such as heart rate and oxygenation.
The main activities in this period were dedicated to the development of sensory mechanisms for unobtrusive monitoring and feedback of fetal parameters ready for integration into the PLS system with emphasis to brain oxygenation and perfusion. In addition, simulation studies (Monte Carlo) were performed in order to identify the best analysis algorithm for brain oxygenation assessment in the fetus.
In addition to the substantial activities mentioned above, actions were taken for dissemination of results to stakeholders and promotion of further uptake of results, the creation of a development and exploitation plan.The project has been managed regarding implementation, financial aspects, monitoring, meetings, and reporting. In the first year of the project, we actively worked to begin forming connections to parents and advocates to form an Advocate Advisory Board (AAB) and to broaden our networks. We also managed to obtain extra funding for valorization of the project’s outcome and defined “WP9” for continuing this activity as additional part of the PLS project.