BCNatal's fetaLife project for extremely premature babies achieves a 21-day survival in a liquid incubator

After more than five years, the scientific team of the fetaLife project has developed a functional prototype of an artificial placenta or liquid incubator that has achieved 21 days of survival in good condition in an experimental model and more than 13 months of postnatal survival once outside the device with good neurodevelopmental results. Led by Dr. Eduard Gratacós, this disruptive initiative promoted by the Fundació "la Caixa" with 7.65 million euros, is being carried out at BCNatal, a clinical and research center in fetal and neonatal medicine attached to the Hospital Sant Joan de Déu, the Hospital Clínic Barcelona and the University of Barcelona.

The managing director of SJD Barcelona Children's Hospital, Miquel Pons; the director general of Hospital Clínic Barcelona, Josep Maria Campistol; the Deputy Director-General for Research and Grants at the Fundació "la Caixa", Àngel Font; the Director of BCNatal and leader of the fetaLife project, and Professor at the Faculty of Medicine and Health Sciences at the Universitat de Barcelona (UB) and researcher of the Maternal-Fetal and Complex Patient program at Institut de Recerca Sant Joan de Déu, Eduard Gratacós, and the medical and scientific coordinator of BCNatal's fetaLife project, Elisenda Eixarch, have presented the initial results of Europe's first experimental artificial placenta project.

Over the course of more than five years of work, the scientific project has developed a first integrated prototype of a liquid incubator or artificial placenta that has exponentially increased survival within the system to currently reach 21 days in good conditions in an experimental model. More than 13 months of postnatal survival have also been achieved with good neurodevelopmental results after going through the liquid incubator.

This is a milestone in this highly complex project, promoted by the Fundació "la Caixa" with 7.65 million euros. Its objective is to increase survival and, above all, reduce the serious sequelae that affect the majority of the most extreme premature newborns, that is, those born at six months or less.

A liquid incubator is a system in which a very preterm baby can live in a way that resembles life in the womb, offering a more natural solution. The prototype developed by BCNatal, of which several versions have already been produced, features a liquid environment and allows the premature baby to continue developing whilst connected to an extracorporeal circulation system via its umbilical cord.

Technological improvements and major advances in medical support protocols - which include the administration of nutrition, hormones and other medications, and which anticipate possible clinical scenarios and the medical interventions required to address them - have led to improved survival rates within the system and a successful neonatal transition in sheep. This transition simulates the steps envisaged for its future application in humans: transfer from the liquid incubator to a conventional incubator once the organs have matured.

The system's own monitoring system remains key, enabling the medical team to carry out continuous remote monitoring in order to maintain close control over the foetus's condition and development. Another major advance achieved to date has been the improvement of the extracorporeal circulation system, comprising an oxygenating membrane and a set of components (tubing and cannulas) that have been specifically designed to facilitate blood circulation and oxygenation, simulating the natural process that occurs in the womb via the maternal placenta and the umbilical cord.

Experimental validation phase to bridge the gap to clinical practice

Using a sheep model, the team has so far designed and described the surgical techniques and protocols required to carry out a transition from the uterus to a prototype liquid incubator without incident, and has achieved a survival rate of 21 days within the system.

A significant step has been taken to bring the system closer to the clinic: verifying that neonatal transition is possible. Neonatal transition is a process similar to the "birth" of the fetus, in which it passes from the liquid incubator to extrauterine life and begins to use its lungs like any other baby. The project has carried out trials that have allowed viable newborns to be obtained after being kept in the liquid incubator. In one specific case, that of the Gaia sheep, which is now over a year old, its long-term neurodevelopment has been studied and normal results have been obtained.

Since its inception in 2021, the project has had its own committee to address ethical, social and safety issues, on which the families of the newborns are represented. The ethical aspects involved in transferring the system for use in humans are led by the Borja Institute of Bioethics, with which the project's research team works in collaboration.

The project has been reviewed and favourably assessed on two occasions by a panel of internationally renowned experts in foetal and neonatal medicine from five countries.

This is an example of the multiplier effect of collaboration between public institutions and philanthropy in biomedical research and innovation. BCNatal is a clinical and research center in fetal and neonatal medicine attached to the Hospital Clínic Barcelona and the SJD Barcelona Children’s Hospital. On the other hand, the Fundació "la Caixa", which has promoted the project from the beginning with 7.65 million euros, has made the experimental part of the project possible and has consolidated it as the only one of its kind in Europe.

Following the results obtained, fetaLife Technologies was created in 2025, a spin-off company of the Hospital Clínic, the SJD Barcelona Children's Hospital and the University of Barcelona that aims to bring the technology closer to clinical practice. Next year, the project team will focus its efforts on introducing a technological improvement, in collaboration with industry, to adapt the system to use in humans, and also on starting the ethical and legal preparations so that a first study in humans can be approved, planned for 2028-2029, with the necessary investment. The entry of other funders is expected for this new stage. As for the "la Caixa" Foundation, it has already announced that it will continue to support the project, which has also received donations from other entities.

Recreació de com podria ser la futura aplicació clínica del projecte en humans
Recreation of what the future clinical application of the project in humans could be like
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A groundbreaking solution to save the lives of premature babies

Although more than 90% of pregnancies end normally, fetal life remains one of the most important phases in human development. One of the main unresolved problems is extreme prematurity (six months or less), a casuistry that affects 25,000 families each year in Europe alone. Survival in extremely premature babies, even in units of excellence, is low (between 25 and 75%), and a significant proportion of survivors have significant sequelae throughout their lives.

Before six months of pregnancy, the lungs, intestines and brain of the fetus are poorly developed and not ready to function properly. An extremely premature newborn is, in fact, a fetus that has to survive in a very unnatural environment. Weighing less than 1,000 grams, these babies need respiratory support and intravenous feeding to stay alive, but this can cause complications and can have an impact on their future life. Therefore, the liquid incubator may be a solution that improves the quality of life of these newborns.

The research group led by Dr. Gratacós has a strongly interdisciplinary nature. More than 35 researchers from different disciplines are participating in the project - doctors from various specialties, biologists, engineers, nursing staff - and 35 other professionals are collaborating, although in some phases up to 150 people have been involved.

In addition to BCNatal's fetaLife project, there are currently only four other groups in the world - one in Philadelphia and another in Michigan (United States), a consortium between Australia and Japan, and another group in Toronto (Canada) - that have developed similar experimental models and have achieved significant progress in recent years.

The scientific project has developed a first integrated prototype of a liquid incubator that has exponentially increased survival within the system, currently reaching 21 days in good conditions in an experimental model.

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