Revolutionising Preterm Infant Care
The Perinatal Life Support (PLS) project envisions a groundbreaking solution for extremely premature infants. The innovative system replicates the womb’s protective environment, incorporating an artificial placenta, computational models, and fetal monitoring mechanisms. Pioneered by an interdisciplinary consortium, it brings together cutting-edge technology and medical expertise for improved neonatal outcomes.
Preterm birth is a leading cause of perinatal and neonatal mortality, posing lifelong morbidity risk for infants. The most vulnerable are extremely preterm infants who are born before 28 weeks of gestation.
In transitioning from the protected fetal environment to the harsh realities of neonatal life, they encounter tremendous challenges due to their underdeveloped organs and face the potential of lifelong disabilities, spanning cardiovascular, neurological, breathing, and metabolic problems. Some of the potential complications that occur during this critical phase include heat loss, respiratory challenges, circulatory disruptions, nutrition deficiencies, susceptibility to infections, and invasive procedures. The current approach to caring for these newborns involves the initiation of organ functions, however, their lungs and gut are not yet well-suited for such interventions.
The Perinatal Life Support (PLS) consortium aims to revolutionize the care provided to extremely premature infants. The primary goal is to create an environment for premature babies that closely resembles the protective and nurturing conditions of the maternal womb - an innovative system of care that recreates ex vivo innate fetal cardiorespiratory physiological conditions.
At the heart of this groundbreaking system lies an artificial placenta, enabling the exchange of oxygen and nutrients crucial for the baby’s development. Continuous noninvasive monitoring of foetal parameters and the use of a foetal manikin for simulation purposes further enhance the capabilities and application of the system. To guide and optimize their efforts, the team harnesses the power of computational modeling, bringing together an interdisciplinary ensemble of academia and industry partners.
“Alan Flake, a scientist in Philadelphia managed to let a lamb survive in a liquid-based environment in which the lamb is not ventilated with air through the mouth and lungs, but oxygenation and nutrition is performed via the umbilical cord. The idea is that we could replace the incubator as it is used now with air-based ventilation, by an incubator that works on this
principle. That means you have to make an incubator in which the preterm is not breathing, so still in a liquid environment” explains Prof. van de Vosse. “So, what methods do we need to use to go from an idea to an actual properly working, safe, and accepted product? How can we go from science to engineering? In our vision, modeling the system - making mathematical, physiological, and experimental models is the key ingredient because we need a first-time-right solution. We have to verify the system in all aspects as much as possible without doing experiments in the hospital and without unneeded experimentation on animals. What we need is a digital twin of the entire perinatal life support system, including the perinate” he continues.
The liquid-based environment
The first step is to create a liquid-filled environment. Creating a liquid-based prototype is explored via two approaches. An (artificial) amniotic fluid-filled incubator involves creating an environment that resembles the fluid surrounding a developing fetus. The infant, represented by a manikin, will be placed in this incubator, providing a nurturing space
extremely premature infants and provide effective oxygenation and waste removal. A membrane oxygenator replaces the lung function of the placenta. The design considers the cardiorespiratory function and capacity of the fetus, ensuring compatibility with the liquid system and fetal manikin. A heat exchanger may be included to maintain body temperature.
Computational models and monitoring system
that supports lung development. The other approach is the non-submerged alternative. The manikin’s lungs are kept fluid-filled while the rest of the body remains outside the liquid. This method aims to create optimal conditions for lung development while reducing the complexity of the environment.
The fetal manikin and transfer devices
The fetal manikin used in the PLS project accurately replicates the physiology of extremely premature infants. The manikin is created using 3D-printed tissue- and organ-mimicking materials that are based on high-resolution MRI images of 24week gestational age fetuses. The manikin simulates cardiorespiratory physiology, specifically the heart, and vasculature. The manikin is equipped with sensors and actuators that produce signals that can be measured with the sensors.
The extracorporeal artificial placenta
The advanced artificial placenta should be able to support the vital functions of
Predictive models are key in this project. The predictive models are able to predict the behavior of a 24-28 week old perinate, support medical decisions as it knows the perinate’s state and predict its behavior. The team also utilizes models that can predict the impact of the incubator. Gathering data about the perinate’s state is done through monitoring systems - sensory mechanisms that monitor fetal parameters. These include the creation of electrodes to measure fetal core temperatures, near-infrared spectroscopy (NIRS) and diffuse correlation spectroscopy (DCS) to assess oxygenation and flow in various tissues and digital cameras that measure signals like motion and skin color. Measurement of clinical parameters such as fetal heart rate, blood pressure, and oxygen saturation is used in order to validate the effectiveness of the developed sensory and feedback mechanisms. These parameters are fed into computation models. This validation process ensures that the system accurately captures and interprets the vital signs of the fetus, enabling precise monitoring and reliable decision support.
Ensuring the bond between the mother and the baby is one of the challenges that the team plans to overcome. “One of our ideas is making sure there is interaction between the mother and the baby, either by allowing the mother to look at the baby or by using sound. The sound in the mother can be recorded and transferred to the PLS system so the baby can hear the same sounds it would hear if it were in the mother’s womb. We can also record the movement of the baby and transfer that to a band that is placed on the mother’s stomach. That would enable the mother to feel what is going on in the PLS system” explains van de Vosse.
The PLS project is coordinated by the Eindhoven University of Technology in close collaboration with the Maxima Medical Center. The fetal manikins are made at the industrial engineering department at Eindhoven. The interdisciplinary consortium includes the RWTH Aachen University responsible for the development of the liquid-based environment and artificial placenta, the Politecnico di Milano and Nemo Healthcare who are involved in the monitoring systems and technical validation of the project, and the LifeTec Group which is also working on the development of the artificial placenta. The decision support system is developed at Eindhoven, together with Nemo Healthcare and Politecnico di Milano. This interdisciplinary consortium compromises world-leading specialists in obstetrics, neonatology, industrial design, mathematical modeling, ex vivo organ support, and noninvasive fetal monitoring. By combining their expertise, the PLS partners are paving the way for significant advancements in perinatal care.
Perinatal Life Support Project Objectives
The Perinatal Life Support (PLS) consortium aims to revolutionize care provided to extremely premature infants. An innovative system that closely replicates the protective conditions of the mother’s womb will improve the outcomes for the most vulnerable babies. Its components include a liquid-filled environment mimicking the amniotic chamber, an artificial placenta for oxygenation and waste removal, physiological fetal manikins, advanced computational models for predictive analysis, and sensory mechanisms for monitoring fetal parameters.
Project Funding
This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 863087.
Project Partners
Together, the PLS partners provide joint medical, engineering, and mathematical expertise to develop and validate the Perinatal Life Support system using breakthrough simulation technologies. The interdisciplinary consortium will push the development of these technologies forward and combine them to establish the first ex vivo fetal maturation system for clinical use. This project, coordinated by the Eindhoven University of Technology brings together worldleading experts in obstetrics, neonatology, industrial design, mathematical modelling, ex vivo organ support, and non-invasive fetal monitoring. https://perinatallifesupport.eu/consortium-partners/
Contact Details
Prof.dr.ir. Frans N. van de Vosse
Department of Biomedical Engineering, Eindhoven University of Technology
Building Gemini-Zuid 4.131
T: +31 40 247 4218
E: f.n.v.d.vosse@tue.nl
W: https://perinatallifesupport.eu/project/
Frans van de Vosse
Frans van de Vosse is a professor of Cardiovascular Biomechanics at the Department of Biomedical Engineering at Eindhoven University of Technology. His research is related to computational and experimental biomechanical analysis of the cardiovascular system and its application to clinical diagnosis and intervention, cardiovascular prostheses, extra corporeal systems and medical devices. He is the author or co-author in more than 240 scientific publications.
“What we need is a digital twin of the entire perinatal life support system, including the perinate.”A fetal manikin kept submerged in a transferbag during a simulation of the transfer procedure (dept. of Industrial Design, Eindhoven University of Technology). Research prototypes made by the dept. of Industrial Design (Eindhoven University of Technology) being exhibited to the general public at Dutch Design Week 2022.