A University Hospital neonatologist’s passion to save premature babies was instrumental in the U.S. Food and Drug Administration’s 2018 approval of Omegaven, a lifesaving fish oil treatment for babies with gastrointestinal complications.
“I couldn’t continue to see these babies bleed to death without doing something about it,” said Cynthia Blanco, M.D., chief of the Neonatal Intensive Care Unit at University Hospital as well as professor of pediatrics and Greehey Family Foundation Chair in Neonatology Research at UT Health San Antonio.
Because critical development of the gastrointestinal system occurs in the last few weeks of a full-term pregnancy, some preemies born with shortened intestines received IV or intravenous feeding.
The IV nutrition was needed to survive, but prolonged feeding of the standard soybean oil-based food was leading to liver failure, the need for a liver transplant or death.
Dr. Blanco learned a Boston hospital was having some success with Omegaven, a fish oil-based formula used in Canada, Australia and Europe, but not approved for widespread use in the United States. She applied for an investigational new drug license to gain ready access to Omegaven for her patients.
It took some doing. University Health System’s pharmacy department had to obtain a special veterinary license to import the fish oil medication, and since it wasn’t FDA approved, the Health System offered it free of charge.
The effort paid off.
Her study was the first in the U.S. to examine the acute and long-term outcomes of feeding preterm infants with the fish oil-based emulsion. The results were impressive. Thirteen preterm babies received Omegaven until their conditions improved. All of them became healthy enough to go home. None required transplants or died.
“Overall, since 2011, we have had more than 50 patients enrolled in our long-term study and the risk of death due to liver disease has decreased to zero,” said Dr. Blanco.
Currently, Dr. Blanco and her team are helping write the national guidelines for Omegaven, and continuing with research to determine the optimal dose for preterm babies who will have a better chance at growing up healthy.