Giving Babies a Better Chance at Life

By Robin Overbay, PA-C
Friday, December 14, 2018

The research efforts of Cynthia Blanco, MD, Medical Director of the Neonatal Nutrition & Bone Institute at University Health System and Professor of Neonatology at UT Health San Antonio, recently helped the medication Omegaven gain FDA approval. The medication, developed by German healthcare company Fresenius Kabi, helps save the lives of infants with parenteral nutrition-associated liver disease.

Cynthia Blanco, MD, Medical Director of the Neonatal Nutrition & Bone Institute at University Health System and Professor of Neonatology at UT Health San Antonio

Liver disease is a potential side effect from long-term parenteral nutrition (PN), also known as intravenous nutrition. Babies who cannot feed or absorb nutrition traditionally, usually due to conditions that affect the gastrointestinal system, would essentially starve to death without PN. Parenteral nutrition-associated cholestasis (PNAC) can result, and the condition could require a liver transplant or lead to death.

A Newly Approved Drug Improves Outcomes

Omegaven is a lipid emulsion containing 10 percent fish oil with a high percentage of very long-chain omega-3 fatty acids that can be infused intravenously. Omegaven infusions allow babies to better absorb calories and fatty acids, despite conditions that may hinder nutritional absorption and growth. The medication has been a beneficial tool in managing patients with PNAC.

Before the introduction of Omegaven, approximately one in three babies with PNAC would die from liver disease, Dr. Blanco says. By adding Omegaven, the outcomes of babies on PN improved significantly. In most cases, infants with PNAC experienced partial or total reversal of liverdisease.

“PNAC was improved in 80 percent of patients at the end of treatment with Omegaven, and the other 20 percent continued to improve even after stopping this medication,” Dr. Blanco says. “Only one patient from our center required liver transplant, but none have died due to liver disease.”

Additionally, for the babies in the multifacility study who did need a liver transplant, Omegaven helped them survive long enough to receive the new organ, according to Dr. Blanco. The medication, she says, has few side effects and massive benefits.

“Side effects with Omegaven are rare, in my experience, and are comparable to those of other IV lipids,” Dr. Blanco says. “The only adverse effects I saw were hypertriglyceridemia or hyperglycemia, which only occurred occasionally in very small, premature infants. Additionally, these side effects resolved after reducing the dose or slowing the infusion rate.”

“At University Hospital, we have a mission of discovery in addition to providing the highest level of care, and with Omegaven, have already saved lives. This FDA approval is critically useful for babies who cannot absorb nutrition otherwise.”
— Cynthia Blanco, MD, Medical Director of the Neonatal Nutrition & Bone Institute at University Health System and Professor of Neonatology at UT Health San Antonio

The Value of a Teaching Hospital

Teaching hospitals are often at the leading edge of research and offer some of the most advanced technologies and treatments. Additionally, these hospitals train future healthcare professionals so the legacy of clinical excellence and quality care can continue.

Teaching hospitals have a mission of discovery and strive to improve upon what we already know about medicine to advance care, often participating in advanced research and clinical trials. As a result, patients are able to get potentially lifesaving treatments and medications early, rather than after they are approved when it could be too late.

Cynthia Blanco, MD, Medical Director of the Neonatal Nutrition & Bone Institute at University Health System and Professor of Neonatology at UT Health San Antonio, stresses the importance encouraging families and patients to believe in the important work of academic institutions and take an active role in clinical trials when they are available. Research performed at these institutions may later become the standard of care.

“I know in my institution, Omegaven, for example, has already saved over 60 babies who participated in the clinical trial,” Dr. Blanco says. “While maybe not all would have died of liver disease, history tells us that 30 percent of babies with parenteral nutrition-associated cholestasis — meaning one of every three babies — will die. Participating in the Omegaven research has been one of the most rewarding things in my career.”

Dr. Blanco is passionate about her profession and the progress she sees in the infants she cares for.

“I love being part of the beginning of their lives and watching them become well-nourished babies when they started so fragile,” she says. “I love helping them reach their highest potential and defy the odds with therapies we can utilize early in life. There is a quote from our PREMIEre follow-up clinic that helps me describe how I feel when taking care of the tiniest patients: small beginnings, great expectations.”

To learn more about the NICU at University Hospital in San Antonio, Texas, please call 210-358-1593.

Evaluating the Research

Dr. Blanco’s team only participated in prospective cohort studies instead of randomized drug trials because, ethically, they could not justify withholding a potentially lifesaving medication in order to establish a control group for the study. Dr. Blanco felt that the risk of withholding Omegaven from babies with established liver disease would be risking their lives. In fact, due to the drug’s efficacy, no randomized drug trials were performed anywhere in the U.S.

Dr. Blanco’s work involves the tiniest babies at University Hospital, many of whom require long-term intravenous nutrition.

“We got approval from the FDA for IND for Omegaven in 2011, and we have enrolled approximately 62 patients during that period as a cohort study,” Dr. Blanco says. “We followed them prospectively long-term [for three years] to evaluate short- and long-term outcomes.”

Omegaven has been approved for several years in Europe, Canada and Australia. While the medication has been used to reduce liver disease in patients with PNAC, some European studies have also demonstrated positive results when measuring the medication’s effects on retinopathy orprematurity.

“I think the main area of research will continue to look at whether or not there is any impact on the immune system,” Dr. Blanco says. “Other research may evaluate if there is an impact when using Omegaven with a combination of another Intralipid to provide a more diverse blend of omega-3, 6, and 9 fatty acids that is similar to what breast milk provides.

“With the advent of Omegaven, we can figure out a better nutrition and free fatty-acid profiles for babies who have other disease processes that place them at risk for poor nutrition,” Dr. Blanco continues. “I also foresee that Omegaven can be helpful in neural development.”

“Our NICU implemented the Angel Eye program, a camera system so parents can see their baby, and the Baby Chat system so they can talk to their baby through this technology. A lot of patients are transferred from different institutions, so this technology allows their families to see and talk to them as much as they want, even if they live far away.”
— Cynthia Blanco, MD, Medical Director of the Neonatal Nutrition & Bone Institute at University Health System and Professor of Neonatology at UT Health San Antonio

Advanced Approaches and Leading-Edge Technology

Through advanced technology and state-of-the-art treatments, University Hospital neonatal care team provides babies with complex medical histories a better chance at survival. Recently, University Hospital was designated a Level IV NICU. The Neonatal Nutrition & Bone Institute at University Hospital plays a vital role in the program’s success.

Dr. Blanco examines a NICU baby at University Hospital.

The Neonatal Nutrition & Bone Institute is the only institution of its type in San Antonio and one of two in Texas that has the ability to provide full-body composition analysis. This technology allows neonatologists to measure more than just weight gain, length and head circumference when measuring growth. They can also measure the baby’s percentage of lean and fat mass, which allows them to provide a more comprehensive approach to growth and development.

“A multidisciplinary team at the Neonatal Nutrition & Bone Institute meets at least once a week to review the cases of babies who have liver disease or conditions that need increased surveillance for nutrients necessary for development,” Dr. Blanco says. “We want to develop the best plan of care for each patient to achieve the best nutritional balance.”

To meet this goal, Dr. Blanco’s team works together with pediatric gastroenterologists, neonatologists with expertise in pulmonary disease and bone disease, and pharmacists. Four dietitians specializing in short bowel syndrome and liver transplant are dedicated to the Neonatal Nutrition & Bone Institute, with outpatient dietitians providing follow-up care.

“We get to know our patients from the inpatient world,” Dr. Blanco says. “Because they’re already well known to our team, we’re ready to follow them long-term when they go home.

“It’s not just what we do in the NICU or in the neonatal period, which is very important, but we also want to see how what we did early on translates to later outcomes and if there is anything we can improve.”

Visit or call 210-358-1593 for more information.