In March 2023, SciTechDaily reported on a study in the JAMA Network Open, where new research revealed that Black infants got severely affected by necrotizing enterocolitis (NEC) in comparison to White infants between 1999 and 2020. This happened despite all the improvements in the mortality rates owing to the disease.
Recent medical studies have revealed a connection between certain types of baby formula and the occurrence of necrotizing enterocolitis (NEC). Prematurely born infants often receive baby formula as a substitute for breast milk to help with their nutritional needs and promote growth. However, certain brands and variations of baby formula contain cow’s milk, which poses a risk to infants. It is especially true for premature babies who can develop NEC.
What Is Necrotizing Enterocolitis?
Necrotizing enterocolitis (NEC) is a fatal disease with a survival rate of approximately 44%. It typically affects newborns and takes place in 1 in every 1,000 live births. While NEC can occur in full-term infants, it is predominantly observed in preterm infants born before 36 weeks of gestation. Also, 70% of cases occur in this group. The incidence is notably higher among very low birth weight infants weighing under 1,500 grams.
NEC develops when bacteria invade the intestinal walls, causing infection and inflammation. As the disease progresses, the inflammatory response compromises the blood supply to the tissues, leading to tissue death (necrosis) and the formation of perforations in the intestines.
A few of the symptoms of NEC in babies include:
- Bloody stool
- Abdomen bloating or swelling
Additionally, your baby might also have infection symptoms like:
- Disturbed breathing or apnea
NEC can also result in circulatory collapse and respiratory failure. Another condition that can arise is cyanosis, characterized by the discoloration of the feet, fingertips, or hands due to an inadequate supply of oxygen-rich blood.
The Link Between Baby Formula and NEC
In May 2022, the Daily Record reported on a Morris County woman who joined a nationwide group of mothers in taking legal action against a Chicago-based company that manufactures Similac. The woman asserted that her premature infant’s death was a direct outcome of using the cow’s milk-based baby formula manufactured by the company.
In her lawsuit filed in the U.S. District Court in Northern Illinois, Nicole Cresap blamed Abbott Laboratories for deceptive marketing practices. The lawsuit alleges that the company promoted its formulas as safe for premature infants, despite being aware of medical and scientific evidence that suggests otherwise.
According to the 69-page lawsuit, Abbott, the manufacturer of adult supplements Ensure and Glucerna, as well as baby formula, knew that their cow’s milk-based formulas could significantly increase mortality among premature infants. However, the company did not communicate this risk to the FDA, physicians, and hospitals.
Responding to this allegation, Abbott spokesperson Karen Twigg May, said that the brand has spent ample time in extensive research, testing, development, and the production of baby formulas for premature infants. Hence, such an accusation lacks all merit.
Nevertheless, TorHoerman Law states that if your child was fed with cow’s milk-based baby formula and developed NEC, you can file a lawsuit and seek compensation. However, parents need to conduct the required medical tests, such as blood tests, abdominal X-rays, and fecal tests, to confirm the authenticity of their claim. Parents can file a legal complaint 2 years from the diagnosis date. The statute of limitation can vary based on the state where you stay.
Medical Community’s Attempt to Better Understand NEC
In December 2022, UNC Health reported on the Chan Zuckerberg Initiative (CZI), which provided grants for promoting collaboration between patient organizations and researchers. The mission was to enhance their knowledge of the basic biology underlying rare diseases.
The UNC-Chapel Hill researchers, in association with the NEC Society, came up with a CZI-funded project, “Integrating Patients to Accelerate the Science Towards a World Without NEC.” The $1 million initiative was taken to research the cellular habitat of the neonatal gut, especially in NEC (Necrotizing Enterocolitis).
The project secured $1 million as its initial funding for the first two years. It also has the potential to obtain another $1 million in the following two years, which is subject to evaluation.
Jonah Cool, the Science Program Officer for Single-Cell Biology at CZI, shared that single-cell technologies hold immense potential in expediting scientific knowledge. Researchers are leveraging these technologies to get better insights into the maturation of cells and organs and their connection to pediatric diseases.
Misty Good, MD, MS, at the UNC School of Medicine, emphasizes the urgency of understanding necrotizing enterocolitis (NEC) due to its sudden onset, rapid progression, and severe consequences, including high mortality and morbidity rates.
There is still a dearth of medical data when it comes to NEC and what causes it. The medical community is in dire need of improved strategies for early detection and prevention to reduce the havoc caused by NEC.
FDA Guidelines for Baby Formula Manufacturers
In April 2023, Drugwatch reported that the U.S. Food and Drug Administration was taking proactive measures by issuing new guidance for baby formula manufacturers. It includes:
- Adhering to quality control and regulations
- Letting the concerned agency know if a formula is contaminated after it moved out from the facility
- Reassess the production process
- Take the correct action when needed
Furthermore, baby formula manufacturers should alert the FDA when any product sample tests positive for salmonella or Cronobacter, which can pose a risk to infants.
There are a few measures that may help prevent the development of NEC in babies. According to Cleveland Clinic, if a preterm birth is anticipated, corticosteroid injections should be administered to the mother. This practice enhances the health of the fetus and can reduce the likelihood of intestinal and lung complications. Additionally, feeding the infant with breast milk has been shown to lower the risk of NEC.
However, in cases where mothers discover that their babies have developed NEC due to the use of baby formula products, they have the option to seek both medical and legal assistance.