On Wednesday, the FDA met to discuss the concept of artificial wombs, which simulate a womb-like environment for premature babies, potentially aiding their survival by providing nutrients and medications through umbilical cord-like connections.
Artificial wombs offer the possibility of providing an environment for extremely premature infants born before 28 weeks of gestation, allowing them to grow and develop as if they were still in the womb. While current incubators help regulate temperature, they cannot replicate the womb’s exact conditions.
“It’s an amazing first step to potentially extending viability and improving morbidity and mortality outcomes for our preterm newborns,” said Dr. Shaliz Pourkaviani, a New York City-based board-certified neonatologist.
The use of artificial wombs for premature babies has been tested in animals, but there are numerous complexities to address before human trials can be considered.
During a two-day meeting, FDA advisers discussed the potential structure of human trials and the intricate medical factors that need to be considered in this emerging field of technology.
Artificial womb technology has the potential to be a critical advancement in saving the lives of premature babies. Prematurity, defined as birth before 37 weeks of pregnancy, affects 1 in 10 babies in the United States, making this technology an important area of research and development.
Premature birth increases the risk of death or complications, accounting for 16% of infant deaths. It can also result in developmental challenges for vital organs like the lungs, intestines, and brain.
FDA advisers emphasized the need to address ethical considerations before conducting human trials on artificial wombs, including the medical principle of “do no harm.”
“We as neonatologists want to support life and minimize pain and suffering in the process,” said Pourkavian. “The unknowns, such as if this will be painful and do the benefits outweigh the potential risks, raise many concerns.”
Ethical concerns related to artificial wombs include the long-term consequences, like potential complications from materials used, and the redefinition of “viable pregnancy” and survivability standards in pregnancy.
“Accepted gestational age for viability used to historically be accepted as 23 weeks and (weighing) above 500 grams,” Pourkaviani said. “However, over the last few years, there has been a push to extend this as low as 22 weeks.”
However, Artificial wombs hold groundbreaking potential despite the challenges they may pose.
“This will be groundbreaking in our field of neonatology,” she said. “Premature babies who otherwise would have not had an opportunity to grow and develop in extrauterine conditions have a chance of survival.”