About 70 percent of babies born at 24 weeks survive to discharge or a year, and even fewer survive earlier births
A Food and Drug Administration (FDA) advisory committee met last week to discuss human trials of artificial wombs, which could someday be used to keep extremely premature or preterm babies alive.
Artificial wombs have been tested on animals, but never in human clinical trials. The FDA has not yet approved the technology, but the advisory panel discussed the available science, as well as the clinical risks, benefits and ethical considerations of testing artificial wombs with humans.
“It’s a new treatment modality,” Matthew Kemp , an obstetrician at the National University of Singapore, tells Max Kozlov of Nature News . “The bottom line is that they have to make a really strong case that it’s better and safer in the short and long term” compared with current treatments.
In 2020, an estimated 13.4 million babies worldwide will be born prematurely (or before 37 weeks of pregnancy), accounting for more than 10 percent of all births. Preterm birth is the leading cause of death in children under the age of five, according to the World Health Organization .
Preterm births have the highest associated risk when they occur in the first 26 weeks of pregnancy. Approximately 70 percent of babies born at 24 weeks survive to discharge or one year, and even fewer survive earlier births: only 56 percent of babies born at 23 weeks and 30 percent of those born at 22 weeks survive, according to FDA briefing materials . Extremely premature babies who survive are at risk of developing health problems or impaired neurological development.
Current treatments include placing the preemie in an incubator, connecting him or her to a ventilator, and feeding nutrients and fluids through a tube.
Artificial wombs, however, are designed to more closely resemble the prenatal environment. The company Vitara Biomedical is working on an artificial womb that looks like a plastic bag, with tubes that deliver amniotic fluid, oxygen and medications, writes Liz Essley Whyte of the Wall Street Journal . The technology has been tested in animals, including lambs and pigs.
Notably, the artificial wombs cannot grow a baby from conception to birth; the researchers do not intend for them to replace a human mother. Instead, the technology is intended to help babies born before 28 weeks of pregnancy, according to CNN’s Jen Christensen .
For the treatment to enter clinical trials, the artificial wombs would have to be shown to facilitate growth and development, as well as reduce deaths and health problems in premature babies, compared with standard treatments.
Last week, the FDA panel said that before conducting human trials, scientists should discover the most appropriate animal model to test in an artificial womb, CNN reports. They suggested that human trials be inclusive and include follow-up tests to examine long-term consequences, including complications that could arise from development in a device made of materials such as plastic.
And parents, the panelists said, would need to be informed about the risks of using an artificial womb, which could include infections, brain damage or heart failure, along with the risks of the cesarean section needed to separate the baby from the mother, writes the Wall Street Journal.