Advanced Fetal Care Center (AFCC)
Efficacy of Omegaven
Principal Investigator Dr. Mark Puder is interested in identifying the positive and negative effects of an intravenous fat solution, Omegaven, on Children's who receive their nutrition intravenously (a method called parenteral nutrition). The solution is currently not approved by the Food and Drug Administration (FDA). Information from this research will help determine whether the drug should be approved by the FDA in the future.
Many children who are recovering from complex intestinal surgery or are awaiting intestinal transplant can't eat food. That's because the intestine they do have can't adequately perform its part in the digestion of solid foods. These children are placed on an intravenous method of feeding called pareneteral nutrition (PN).
PN provides the necessary nutrition for children until their digestive systems adapt and they can eat on their own.
PN has revolutionized treatment for diseases such as short bowel syndrome. But its prolonged use often damages the liver, potentially leading to liver failure and the need for a transplant. And unfortunately, infants are at the greatest risk.
They found evidence that the fat used in congruence with standard PN solutions, called Intralipid, was contributing to liver disease by causing fat to accumulate in the liver.
They then tested Omegaven, an IV fat mixture made from fish oil. Fish oil contains omega-3 fatty acids, which have been shown to prevent fat accumulation and have anti-inflammatory properties.
As they hoped, PN using Omegaven as the fat prevented and treated liver injury in the mice.
Surgeon Rusty Jennings, MD, director of Children's Esophageal Atresia Treatment Program and consultant to the Advanced Fetal Care Center, had heard of Puder's research and wanted to try Omegaven in one of his patients. Since Omegaven wasn't approved for use in the U.S., Puder had to receive special permission from the FDA to use Omegaven rather than Intralipid along with the PN solution.
Within two months, the baby's liver function improved so much that he was removed from the liver transplant list.
Puder later treated a second child, a premature baby whose bowel had ruptured; he too had complete resolution of liver disease.
Puder and colleagues are now conducting a formal clinical trial, and have received funding from the March of Dimes and the FDA Ophan Products Division aimed at preventing liver disease in PN recipients. Their work has caused a worldwide shift in treatment.
More than 150 children at Boston Children's Hospital have received Omegaven, and more than 90 percent of them are still alive.