Infant Formula Linked to Necrotizing Enterocolitis (NEC), a Life-Threatening Condition, in Preemies

Welcoming a baby into the world is usually (and should be) a joyous occasion. When your baby is born prematurely, however, this joyous event can quickly turn to worry and concern. Premature babies, or preemies, require much more care and attention to their health, especially with feeding and nursing. Many preemies have trouble with nursing and getting the proper nutrition to build the strength they need to thrive. Often, during this extremely fragile period, physicians will recommend formula feeding for supplemental nutrition.

However, many of these infant formula manufacturers, like Similac or Enfamil, fail to warn new parents and consumers that premature babies have an increased risk of developing a condition called necrotizing enterocolitis (NEC) when fed these products. NEC is a potentially deadly gastrointestinal disorder, characterized by intestinal injury or inflammation that leads to intestinal necrosis, multiple organ failure, and death.

Although studies show (including this one from Johns Hopkins) that premature babies fed human donor milk are less likely to develop NEC than those fed standard premature infant formula, these formula companies do not provide warnings or guidelines about those risks. Many doctors and hospitals remain unaware of these risks as well, and continue recommending them for preemie nutrition.

What is necrotizing enterocolitis (NEC)?

With NEC, the wall of an infant’s intestine becomes infected and inflamed, which can lead to destruction of the bowel wall. This can cause bowel perforation, forcing the contents of the intestine to spill into the infant’s abdomen, resulting in massive infection and possible death.

According to the NEC Society, “thousands of babies develop NEC each year and hundreds of babies die from this complex intestinal condition. Once diagnosed, many babies only live for a few hours or days, and survivors can have lifelong neurological and nutritional complications.” The CDC reports that NEC is one of the leading causes of infant mortality in the United States.

Although NEC most commonly occurs in premature infants, it does (rarely) occur in full-term babies. NEC typically shows up in first two weeks after birth. The Children’s Hospital of Los Angeles (CHLA) reports that NEC affects one in 2,000 to 4,000 births, or between one and five percent of neonatal intensive care unit admissions. NEC occurs in almost 10 percent of premature births, or birth weight of under 3.5 pounds.

What are the symptoms of NEC in preemie babies?

• Abdominal distention and bloating
• Apnea (pauses in breathing)
• Bloody stool
• Decreased blood pressure
• Diarrhea
• Inability to tolerate feedings
• Lethargy
• Low respiratory rate
• Red or tender abdomen
• Vomiting bile

Is NEC curable?

Yes, NEC is curable – but it needs to be treated quickly and correctly. When an infant is showing signs of NEC, immediate medical attention is critical for successful treatment and outcome. Treatment options for NEC are limited but include:

• Stopping feedings
• Inserting a tube from the mouth to the stomach
• Starting intravenous feedings
• Starting a course of antibiotics
• Carefully and frequently monitoring the abdomen
• If necessary, removing necrotic portions of the intestine

In cases where the entire intestine is dead, the chances of the infant surviving are very low. An infant who must undergo multiple surgeries will likely endure long-term or permanent health issues.

Does formula cause NEC in preemie babies?

Potentially. According to the Children’s Hospital of Pittsburgh, “Some experts believe that necrotizing enterocolitis causes have to do with the makeup of infant formula, the rate of delivery of the formula, or the immaturity of the mucous membranes in the intestines.” Studies show there is a link between NEC and these cow’s milk-based baby formulas. Comparing incidence rates of NEC in premature infants exclusively fed human breast milk versus formulas, researchers found that preemies fed only formula were six to 10 times more likely to develop NEC.

Further, 11 percent of premature infants fed formula developed for preemies developed NEC. In comparison, 98 percent of premature infants fed human milk only showed NEC incident rates of about one percent – which is the same NEC risk as full-term infants. Premature infants fed a mixture of human milk and formula had an 8.2 percent incident rate of NEC.

Finally, infants fed donor human milk had identical outcomes to those exclusively breast-fed by their birth mothers. These studies make it clear that feeding premature infants human breast milk rather than formula is key to minimizing the risk of a baby developing NEC.

What kinds of formula increase the risk of NEC in preemies?

NEC typically develops in premature infants being fed formula (cow’s milk-based, or “bovine” formula) rather than breast milk.

Which formulas are bovine (cow’s milk) based?

Cow’s milk formulas make up 80 percent of the formula marketplace. These formulas add additional iron and remove butterfat to make it easier for infants to digest. Some of the most popular baby formulas of this type include:

• Baby’s Only
• Bobbie
• Earth’s Best
• Enfamil
• Gerber
• Go & Grow
• Happy Baby Organics
• Holle
• Kendamil
• Lebenswert
• Loulouka
• Parents’ Choice
• Similac

Whether or not a formula is organic does not affect the potential or risk of developing NEC.

Who is at fault if my child developed NEC from baby formula?

Often, parents are not warned about the risks of NEC and cow’s milk-based baby formula – by either their doctor or the manufacturer themselves.

• When a medical professional is negligent and chooses baby formula for your preemie when there are other, better options available, like human donor milk, you may be eligible for a medical malpractice
• When the formula manufacturer fails to warn parents of the risks of NEC, you may be eligible for a product liability

Experienced attorneys can consult with you and your family to investigate your case, your child’s injuries and determine liability, and then hold the right people responsible for your losses.

Please contact Paulson & Nace, PLLC through our contact form or by calling 202-463-1999.