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

Project description

A life support system for extremely preterm new-borns

A large proportion of survivors among extremely preterm new-borns (<28 weeks) face lifelong disabilities associated with cardiovascular, neurological, breathing and metabolic problems. Current approach involves initiation of organ functions but the lungs and gut in preterm organs are not suited for such interventions. The EU-funded consortium will design and develop a totally new system of care for these new-borns by recreating ex vivo innate foetal cardiorespiratory physiological conditions. The system will include an artificial placenta with oxygen and nutrients exchange, continuous non-invasive monitoring of foetal parameters, foetal manikin for simulation of the new-born and corresponding computational modelling. An interdisciplinary team of academia and industry partners have joined forces to demonstrate the functionality of the system in a proof-of-principle.

Objective

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.

Call for proposal

H2020-FETOPEN-2018-2020

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Sub call

H2020-FETOPEN-2018-2019-2020-01

Coordinator

TECHNISCHE UNIVERSITEIT EINDHOVEN
Net EU contribution
€ 792 500,00
Address
GROENE LOPER 3
5612 AE Eindhoven
Netherlands

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Region
Zuid-Nederland Noord-Brabant Zuidoost-Noord-Brabant
Activity type
Higher or Secondary Education Establishments
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Total cost
€ 792 500,00

Participants (4)