Interprofessional Consensus Regarding Design Requirements for Liquid-Based Perinatal Life Support (PLS) Technology

Abstract

Liquid-based perinatal life support (PLS) technology will probably be applied in a first-in-human study within the next decade. Research and development of PLS technology should not only address technical issues, but also consider socio-ethical and legal aspects, its application area, and the corresponding design implications. This paper represents the consensus opinion of a group of healthcare professionals, designers, ethicists, researchers and patient representatives, who have expertise in tertiary obstetric and neonatal care, bio-ethics, experimental perinatal animal models for physiologic research, biomedical modeling, monitoring, and design. The aim of this paper is to provide a framework for research and development of PLS technology. These requirements are considering the possible respective user perspectives, with the aim to co-create a PLS system that facilitates physiological growth and development for extremely preterm born infants.

Ethical, Translational, and Legal Issues Surrounding the Novel Adoption of Ectogestative Technologies

“…33 This also has an influence on design questions, in the sense that it has been suggested that the administration of fetal therapeutic surgery will require that the subject is safely manually accessible. 32 It is important to note that it is believed that such corrective procedures might be performed without risk of maternal morbidity. 34,40 However, even if ectogestation-aided prenatal treatment (EAPT) could facilitate interventions by allowing it to happen outside the strict intrauterine milieu, this does not necessarily yield the normative conclusion that such usage would be ethically commendable as it may, by the same token, exacerbate potential tensions between presumed moral obligations towards the fetus and the pregnant person.…”

“… 33 This also has an influence on design questions, in the sense that it has been suggested that the administration of fetal therapeutic surgery will require that the subject is safely manually accessible. 32 …”

“…29,31 For this reason, it has been stipulated that the alternative of vaginal delivery (while preventing transition to neonatal physiology) will have to be considered, with the relevant comparative evaluation in terms of feasibility, safety, and choice (of note: the possibility of transfer from the mammal womb through the birth canal without exposure to ambient conditions is effectively being researched). 32 Further, the physical impact of the surgical translocation may possibly compromise a person's eventual later reproductive trajectory and is generally compounded by the ethical challenge to justify whether the burdens are proportionate to the envisaged clinical benefits. [33][34][35] We will return to the moral relevance of this surgical intervention below, when we discuss AAPT as a means to advance prenatal therapy.…”

A review study of fetal circulatory models to develop a digital twin of a fetus in a perinatal life support system

“…The current healthcare system seems to have reached its limits regarding the support of neonatal physiology-based intensive care. Therefore, current research investigates a shift in medical care for extremely premature infants from supporting neonatal to remain fetal life ex utero in order to increase the chance of survival, reduce morbidity, and reduce the social economical costs ( 17 – 19 ). To achieve this, the transition from fetus to neonate needs to be postponed until organs have reached a sufficient level of maturity.…”

“…The PLS system will consist of an artificial placenta to supply nutrients and oxygen, a liquid-based environment with artificial amniotic fluid including an amniotic dialyzer, sensors to measure fetal vital signals, and a monitoring and model-based decision support system to interpret the signals and suggest interventions. All these components have to be tailored to the requirements of the PLS system ( 17 ). For instance, to avoid damaging of blood, no blood pumps should be used in the fetal-artificial placenta circulation ( 19 ), which implies that a low resistance, low volume artificial placenta is required.…”