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Does Baby Formula Cause NEC?

Families rejoice and celebrate the birth of a new baby. However, when a baby arrives prematurely, the rejoicing may be tinged with feelings of stress and worry over the baby’s health.

The March of Dimes estimates that there are more than 380,000 babies born prematurely in the U.S. each year. In a recent year, one in 10 babies in the U.S. was born prematurely, earlier than 37 weeks of pregnancy.

The earlier a baby is born, the higher the risk of death or serious disability. The baby may face one or more medical conditions, such as breathing problems, gastrointestinal problems, low blood sugar, dehydration, weight loss, and jaundice, just to name a few. Slow growth is a common problem for premature babies.

These fragile infants often have underdeveloped digestive systems, as well as problems with sucking and swallowing. A premature baby has to be under observation to make sure he develops fully and normally like any healthy child.

The recommended feeding plan for infants is typically mother’s milk. In some cases, doctors recommend donor milk, which is milk donated by another lactating mother. However, premature babies may have difficulty latching on and nursing. Often, they need extra nutrition to deal with their medical conditions or require specialized nutrition plans. Therefore, neonatologists or pediatricians may recommend formula feeding to provide or supplement nutrition.

Doctors generally recommend non-cow’s milk-based supplemental formula. However, some infant formulas, including some designed for premature babies, such as those made by Enfamil and Similac, create high-calorie cow’s milk-based products. These may put premature infants at an increased risk for necrotizing enterocolitis (NEC).

What is NEC?

Necrotizing enterocolitis (NEC) is a gastrointestinal disease that primarily affects premature infants. It primarily affects the intestines of premature babies. Bacteria invade the wall of the intestine. This causes local infection and inflammation, which may eventually break through and destroy the wall of the intestine.

The result may be massive infection and death. According to research published in Advances in Nutrition, “NEC affects 5-12 percent of very-low birth-weight infants, leads to surgery in 20-40 percent of cases, and is fatal in 25-50 percent of cases.”

NEC affects one in 2,000 to 4,000 births, or between one percent and five percent of neonatal intensive care unit admissions. It rarely occurs in full-term babies but happens in 5-10 percent of premature babies. According to the Children’s Hospital Los Angeles (CHLA), one to five percent of intensive care unit (ICU) admissions arise from an NEC diagnosis. This disease generally occurs during the first two weeks of life, after formula feeding has begun.

There are many theories to explain why NEC mainly affects premature infants. However, studies consistently link prematurity and formula feeding to NEC. Most babies have mature lungs by 36 weeks of gestation. However, since babies develop at different rates, there are exceptions to this.

Typically, premature infants are born with underdeveloped lungs and immature intestines. Therefore, the lungs are unable to oxygenate the blood adequately. The intestines do not receive sufficient oxygen. Therefore, the lack of oxygen damages the lining of the intestinal wall. Bacteria that would otherwise live inside the intestine invade the intestinal wall, causing infection and inflammation.

Many infants receive formula in the neonatal intensive care unit (NICU). In some cases, because they are not yet able to suck or swallow, doctors order that they be tube-fed. The more premature the infant is, and the lower the birth rate, the higher the risk of NEC. Many experts believe that cow’s milk-based formulas are the cause of NEC.

Infants with a greater risk for the condition include:

  • Premature infants
  • Infants who are fed formula rather than human milk.
  • Infants in a nursery where an outbreak has occurred. The condition sometimes affects several infants in the same nursery, despite all of the precautions to prevent the spread of infection.
  • Infants who have been seriously ill or received blood transfusions

The risks of baby formula for premature babies

The cause of NEC is not precisely clear. Researchers know that human milk contains important growth factors, antibodies, and immune cells. In 2012, the American Academy of Pediatrics issued a policy statement indicating that “all premature infants should be fed an exclusive human milk diet because of the risk of NEC associated with the consumption of cow’s milk products.” The American Academy of Pediatrics also found that giving preterm infants human milk reduced the risk of NEC.

Breast milk benefits infants in many ways, including supporting the growth of healthy bacteria in the intestines. It contains antibodies that aid a baby’s immune system and proteins that provide anti-inflammatory benefits. However, a premature infant’s intestines may be undeveloped so that the baby cannot digest cow’s-milk proteins and other ingredients in baby formula.

As early as 1990, researchers studied 926 preterm infants, 51 of whom developed NEC. They concluded that breast milk protects infants from NEC. They found that exclusively formula-fed infants were significantly more likely to develop NEC than those who received breast milk at their feedings.

The condition is rarely found in babies over 30 weeks gestation; if the infant did not receive breast milk, NEC was 20 times more common. The study found that NEC was “6 to 10 times more common in formula-fed babies than in those fed breast milk alone, and NEC was 3 times more common in babies fed formula plus breast milk.”

In 2011, several hospitals found that “Extremely premature babies fed human donor milk are less likely to develop the dangerous intestinal condition necrotizing enterocolitis than babies fed a standard premature infant formula derived from cow’s milk.”

A more recent study reviewed 12 complete trials involving 1,871 infants. Based on available evidence, they found that feeding premature infants with artificial formula was linked to faster rates of growth but nearly doubled the risk of developing necrotizing enterocolitis.

Not all infant intestinal problems are preventable, but the use of bovine, or cow’s milk, is a preventable risk that substantially increases the risk of NEC. The risk is greatest for babies weighing less than 2 pounds. About 80 percent of baby formulas and most major brands of formula are cow’s milk-based.

Many major baby formula manufacturers have formulas designed specifically for premature infants. This includes cow’s milk-based formulas like Enfamil and Similac. However, despite the evidence linking formula to NEW, manufacturers do not provide any type of warning that the products may be linked to NEC in premature infants. This is also true of high-calorie cow’s milk-based formulas specially designed and promoted for premature babies.

Symptoms of NEC

Most signs of NEC occur within days to weeks and can differ from child to child, although late-onset may occur many weeks after birth. The most obvious sign is bloating or swelling of the abdomen.

Symptoms may begin slowly or suddenly, but signs and symptoms commonly include:

  • Vomiting, particularly green vomit containing bile
  • Diarrhea
  • Bloody or dark stools
  • Delayed gastric emptying and constipation
  • Trouble feeding
  • Tender, red, or painful abdomen
  • Decreased bowel sounds (ileus)
  • Apnea (pauses in breathing)
  • Lethargy
  • Slowed heart rate (bradycardia)
  • Low blood pressure (hypotension)
  • A low or unstable body temperature
  • Decreased peripheral perfusion
  • Abdominal wall erythema (advanced stages)
  • Shock (in advanced stages)
  • Cardiovascular collapse (advanced stages)

Diagnostic exams and tests

Tests may include:

  • Abdominal x-ray
  • Stool for an occult blood test
  • CBC (complete blood count)
  • Electrolyte levels, blood gases, and other blood tests

Treatment of NEC

Necrotizing enterocolitis is a serious disease. Up to 40 percent of infants with NEC die from it. Early, aggressive treatment can help improve the outcome. The treatment plan depends on the severity of the NEC, the degree of prematurity, and the overall health of the baby. Treatment may be medical, surgical, or both. If the affected area is small and the intestine is not perforated, doctors will usually try medical treatments first.

Medical treatment includes:

  • Stopping all regular feedings. The baby receives nutrients through an intravenous (IV) catheter.
  • Placement of a nasogastric tube extending from the nose into the stomach. The tube suctions air and fluids from the baby’s stomach and intestine, relieving swelling and discomfort.
  • Starting antibiotic therapy.
  • Checking stools for blood.
  • Regular blood tests to look for signs of infection and chemical imbalances.
  • Oxygen or assisted breathing when needed due to abdominal swelling.
  • In some situations, the doctor may order platelet and red blood cell transfusions.

If a child does not respond to medical treatment, or if the intestine is perforated, doctors may perform surgery to remove the damaged areas. The surgeon only removes the damaged parts, leaving as much intestine as possible so that the child can regain function. In some cases, the surgeon places a drain in the abdominal area to remove the infected fluid.

In some cases, the surgeon may create a temporary ostomy (opening in the wall of the abdomen) to allow the bowel to recover. After several weeks or months, the surgeon may reconnect the bowel.

Possible complications of NEC

Approximately half of all NEC diagnosed and treated babies develop long-term health complications after treatment. These may include intestinal perforation, intestinal stricture (narrowing of the intestines), sepsis, peritonitis, liver problems due to the need for IV nutrition, and short bowel syndrome in cases where the surgeon removed a large amount of intestine.

Long-term consequences of NEC include growth delays, developmental delays, trouble absorbing nutrients, and trouble with their livers and gallbladders. If an infant has had surgery due to NEC, they may have other long-term consequences such as nutritional issues, cerebral palsy, and brain and eye problems.

The prognosis for infants with NEC

Tragically, NEC is fatal in about 20-30 percent of babies. However, with prompt, effective diagnosis and treatment, infants suffering from NEC often heal well. Sixty to eighty percent of babies with necrotizing enterocolitis do not require surgical treatment. Many of them recover and lead normal lives.

Who may be liable if my child develops NEC from drinking cow milk-based formulas?

Most manufacturers of baby formula fail to list the potential hazards or risks of preterm infant necrotizing enterocolitis on the packaging of their cow’s milk-based formula. In addition, it is not clear whether hospitals, neonatologists, and pediatricians were aware of the potential risks associated with cow’s milk-based formulas.

If your premature baby suffers from necrotizing enterocolitis due to a cow’s milk-based formula diet plan, you might be entitled to damages.

Your attorney can explain your legal options, such as:

  1. A product liability lawsuit against the maker of the formula. You may have a claim against companies that manufacture and sell baby formula. Some of these products were marketed specifically for use by those with premature infants and contained no warnings about the potential consequences.
  2. A medical malpractice lawsuit against the doctor(s) and/or hospitals. You may have a claim against medical professionals who give these products to preemies instead of mother’s breast milk, donor human milk, or other available non-cow’s milk-based formulas.

Deadline to file a claim

There are strict deadlines for filing a lawsuit. This is called the statute of limitations. The time frame depends on the state and the type of lawsuit. States may also have a different but similar law known as the statute of repose. If you fail to file a claim within this deadline, you cannot seek financial recovery.

Necrotizing enterocolitis diagnosis can be extremely frightening to parents. They just want their baby to thrive and be healthy. Premature infants are so tiny and vulnerable. It is tragic for them to suffer the pain, medical treatments, and long-term consequences of NEC. Parents should rely on those who supply their infant’s food to provide safe and appropriate formula and warn of potential dangers.

If you believe your child suffered from necrotizing enterocolitis after receiving cow’s-milk-based formula, contact an experienced product liability attorney as soon as possible to preserve your legal right to recovery.