OPINION: Medical decisions about the nutritional needs of preterm infants should be made by trained doctors

Every day, families who are experiencing the exciting journey toward parenthood are confronted with the challenging reality of a premature birth. As a result, the joy of welcoming a child into the world is accompanied by an overwhelming amount of concern as they place their premature baby’s life in the hands of doctors and nurses.

Every day, numerous medical decisions are made by the doctors and nurses in order to provide the best care for these babies. Yet new litigation surrounding formula products threatens to get in between the delivery of care from top medical experts and the infants who need it the most.

The litigation relates to a terrible disease called necrotizing enterocolitis, also known as NEC. The cause of NEC is not known but it is related to prematurity and the immaturity of a baby’s digestive system. Dangerous bacteria cause infection and inflammation in the baby’s intestines, which can lead to tissue damage.

According to the NEC Society, a nonprofit founded by families who have been affected by NEC, more than 3,500 infants are diagnosed annually with the disease, including 1 in 10 premature infants. NEC has been happening to premature babies for over 100 years and is seen in babies throughout the world.

NEC is a mysterious disease and finding its cure won’t come through litigation. Yet that has not stopped a new set of lawsuits which blame the manufacturers of preterm infant formula and human milk fortifiers for NEC.

Years of published research shows that human milk, either mother’s own milk or milk from a donor, has unique protective qualities that reduce the incidence of NEC. However, feeding premature infants comes with unique challenges, including an underdeveloped gastrointestinal system. In these situations, every drop of liquid counts, and human milk is often deficient in the nutrition the infant needs.

In fact, a publication from the American Academy of Pediatrics explained, “nutritional requirements cannot be met with human milk alone in the volumes of milk that are generally tolerated by very low birth weight infants because requirements exceed those of healthy term newborn infants in protein, energy, fatty acids, minerals, and micronutrients.” In addition, for a variety of reasons, there is often not enough of mother’s own milk to feed to her baby.

This means that when it comes to feeding premature infants, doctors often rely on formula or milk fortifiers that can deliver the extra nutrients that are needed. As a result, these products are a part of the standard of care for health care professionals across the country, including at Columbia University Irving Medical Center, Beth Israel Deaconess Medical Center, the Children’s Hospital of Philadelphia, and countless other leading medical facilities across the country.

As a neonatologist for over 30 years, I’ve personally prescribed these products as part of the nutritional regimen for my premature patients. These decisions were made and communicated to the parents based on the needs of their newborn. Thousands of premature babies have received formula without any problems. However, recent research has shown us that mother’s own milk should be used if available due to the unique protective properties, which are effectively medicine.

It is concerning that we are increasingly in a world where lawyers, not doctors, are the ones making medical decisions. In states across the U.S., aggressive advertising from trial lawyers threatens to upset the medical decisions for preterm infants made by highly trained doctors.

The rate of NEC has not changed much in the past 20-30 years, even though babies through modern science continue to be born earlier and earlier. Yet these lawyers now allege that, because babies fed human milk are sometimes less likely to get NEC than those whose nutrition plan includes preterm infant formula and human milk fortifiers, those products are the root cause of NEC.

That is not a correct statement. The research shows that human milk contains uniquely protective qualities that guard against harmful disease like NEC. This does not mean that preterm formula products and milk fortifiers cause NEC. Furthermore, the most rigorous and recent studies based on randomized control trials that test preterm formula under real-life clinical conditions, as a supplement to mother’s own milk, demonstrate that preterm formula is similar to donor milk in the incidence of NEC and that human milk fortifiers from bovine sources compared to human milk sources also do not increase the rate of NEC.

Medical decisions about the nutritional needs of a preterm infant should be made by the trained doctors in the NICU, not litigated in the courtroom. Talented medical professionals have years of training and work around the clock to ensure that the most fragile patients in their wards get the nutrients they need to grow strong and live happy, healthy lives.

NICUs are an incredibly stressful environment where the stakes are extremely high. Any NICU doctor or nurse can tell you about the endless cacophony of beeps and whirring from the equipment that is powered all day, every day. But litigation around NEC and formula products are just extra noise that they don’t need. It won’t get us any closer to understanding the causes of NEC, or finding its cure, and it won’t improve outcomes in preterm infants.

Dr. Renate D. Savich is a neonatologist in Albuquerque who has been in practice for more than 30 years. Dr. Savich is affiliated with multiple hospitals in the area, including University of New Mexico Hospitals and University of New Mexico Children’s Hospital, and also serves as a scientific advisor to Abbott.