Edinburg, TX— Doctors Hospital at Renaissance Health System (DHR) was approved by the Food and Drug Administration in August 2016 to become an intermediate site for the use of Omegaven, a potentially lifesaving treatment made with fish oil. Omegaven can both prevent liver inflammation and liver failure in preterm infants and can also heal the damaged preterm liver after exposure to prolonged conventional intravenous fat. Dr. Dynio Honrubia, Neonatologist at the Women’s Hospital at Renaissance, and the Doctors Hospital at Renaissance Research Institute are leading the study that provides preterm infants with this life saving nutritional source. Without the administration of Omegaven in babies who suffer from parenteral inflammation and liver failure, progressive liver disease and liver failure can continue later on in life.
Omegaven is a fish-oil emulsion that is given intravenously to patients who requires parenteral nutrition supplementation. This treatment is encouraged when oral or enteral nutrition is impossible, insufficient or contraindicated, based on the status of the baby. This new treatment is currently approved for marketing in Germany and only in the United States for Investigational New Drug (IND) applications. DHR has acquired an IND with the intention to treat parenteral nutrition dependence and cholestatic liver disease in at least three newborn babies every year with the use of Omegaven.
DHR is one of the few institutions on the country who have been granted permission by the FDA to use the investigative new drug. An application was submitted to request the use of Omegaven in babies at the Women’s Hospital at Renaissance when Dr. Honrubia noticed the need in our area. The next closest available center that administers Omegaven is Texas Children’s Hospital in Houston, Texas.
“Basic science and clinical research have shown Omegaven to be safe and lifesaving when used to prevent or treat the liver inflammation and liver failure that affects extremely preterm newborns,” states Dr. Dynio Honrubia, Neonatologist at the Women’s Hospital at Renaissance. “We are very thankful and extremely proud that the FDA, after reviewing our neonatal outcomes and staff resources, has chosen Women's Hospital at Renaissance to be the first private hospital in the United States to be able to independently prescribe Omegaven.”
With equipment designed for infants and a hospital staff that has professional training in newborn care, the neonatal intensive care unit (NICU) at The Women’s Hospital at Renaissance (WHR) was created for newborns that need specialized treatment. The WHR NICU has consistently ranked among the top 5% of neonatal intensive care units in the United States. For the majority of complications caused by prematurity, including mortality, chronic lung disease, intraventricular hemorrhage, necrotizing enterocolitis, and retinopathy of prematurity—the WHR NICU ranks in the top 5% in the world
