'Biobag' system mimics womb, could provide hope for premature babies

Pediatric researchers in Philadelphia have developed a system mimicking the environment in a mother’s womb that could provide new hope for survival and illness prevention in premature babies.

The research team at the Children’s Hospital of Philadelphia call the system the “biobag.” It consists of a container made of inert plastic and electrolyte fluid that serves as substitute amniotic fluid. It also contains a device  that allows the baby’s heart to pump blood via the umbilical cord and acts in place of the placenta, continually exchanging oxygen and carbon dioxide.

“This is an old idea,” Dr. Alan Flake, study leader, said in a telephone interview Tuesday night. “People pursued it for about 60 years experimentally but we were able to do what others haven’t been able to do and some of that is related to technology,” said the fetal surgeon, who is director of the Center for Fetal Research at the Philadelphia hospital.

Flake and his team of researchers have tested the system on eight pre-term lambs, who did well and whose organs developed normally. Helping premature babies to survive is a growing challenge because advances mean more premature babies are surviving birth, but there still is the challenge of helping them survive and preventing illness, or morbidity. Many premature babies develop lifelong lung ailments and cerebral palsy.

The system was explained in Tuesday’s edition of Nature Communications. It includes three major components, Flake said.

A low-resistance oxygenator is the device that exchanges oxygen and carbon dioxide as blood flows through it. Previous devices with too much resistance caused heart failure in premature infants. The oxygenator employed by the Philadelphia researchers is pumpless and replicates the work of the placenta, Flake said.

The system also does not require tubing be placed in the placenta and this minimizes umbilical spasms that can take place when the baby is born, Flake said.

The third component is the mimicking of the amniotic fluid and creating a fluid environment, the physician said. “It sounds simple and intuitive … but strangely enough, other groups have tried this and they’ve given up,” he said.

Among the reasons that the fluid environment is important is that it gives premature babies’ lungs a chance to mature before they have to contend with the same environment as everyone else, the researchers said.

There are about 30,000 premature infants born each year in the United States, and 120,000 or more in the developed world. There is about a 50% mortality rate for extremely premature infants as young as 23 or 24 weeks and the quality of life of survivors is poor, Flake said.

The research team estimates the device could save tens of thousands of lives each year and improve the quality of life for many premature infants.

The next step is for the research team to develop the clinical  device and a pre-clinical trial on animals, which the Food and Drug Administration has helped the team design. The step after that would be to apply for an investigational device. Flake estimates his team could be looking at trying the system on premature human babies in a few years.

The device provides hope for infants born too soon who suffer in spite of medical advances, said Brad Imler, president of the American Pregnancy Association, based in Irving, Texas. There are about 870 premature infants born in the United States daily, he said.

“The success with the development of lambs to the process is encouraging and anything that we can do to create a healthier environment for the baby to develop is beyond promising, Imler said in a telephone interview. “That’s just exciting because the most vulnerable area for the infant is lung development. If we can create the environment that will allow lung development ... that’s a tremendous investment in premature babies.”