Thank you for contacting Matthews and Associates. Our office is currently closed while the city is working to recover from the effects of Hurricane Beryl, and it may take longer than usual to address your inquiries and calls. We appreciate your patience.
Skip to Content
Matthews & Associates Matthews & Associates

Studies show Premie Baby Formula raises Necrotizing Enterocolitis Risk

Timely Insights on Laws, Issues and New Developements
Several studies have shown that premature baby formula raises the risk of necrotizing enterocolitis. NEC is a condition characterized by variable injury or damage to the intestinal tract. It can cause the death of intestinal tissue. Though NEC most often occurs in premature newborns, it can also occur in term or near-term babies. Signs and symptoms may include abdominal distension, bloody stools, vomiting bile-stained fluid, and pneumatosis intestinalis (gas in the bowel wall) seen on abdominal x-ray.

Infants with Necrotizing Enterocolitis may have temperature instability, lethargy, or other findings of sepsis. The exact cause of NEC is unknown.

Necrotizing Enterocolitis

Necrotizing enterocolitis (NEC) typically affects preterm infants, mainly through the intestines. Bacteria infiltrate the intestinal wall, leading to local infection and inflammation that can ultimately burst through and damage the intestinal wall.

The tragic outcome can be illness and death.

Necrotizing enterocolitis (NEC) affects 5-12 percent of very low birth weight babies, It leads to surgery in 20-40 percent of cases. It can be fatal in 25-50 percent of cases, according to a study published in Advances in Nutrition.

More than 380,000 premature infants are delivered in the United States each year, according to the March of Dimes. Roughly one out of every ten U.S. newborns is delivered prematurely, before the 37th week of pregnancy. Most premature infants go straight to the neonatal intensive care unit in most hospitals. Doctors and nurses who work in those units know that necrotizing enterocolitis (NEC) is a dire threat to all premature babies, but those fed breast milk are significantly less likely to develop the potentially fatal disease.

Premature infants may suffer from a host of problems that include breathing issues, gastrointestinal disorders, low blood sugar, dehydration, weight loss, and jaundice, among other maladies. These infants also develop slowly because of their digestive issues.

Digestive Issues in Premature Babies

Premature babies’ digestive systems and coordination are generally undeveloped. These babies typically have difficulty sucking and swallowing. Consequently, a preterm infant must be closely monitored to ensure proper and complete growth.

Though Mother’s milk is the recommended food source for most babies, in some instances doctors may also propose donor milk supplied by another breastfeeding mother. Premature infants, by contrast, may have trouble latching on and feeding. They often demand additional nourishment or customized feeding strategies. As a result, neonatologists and pediatricians may advise infant formula feeding as a means of providing or supplementing nutrients.

Non-milk-based cow’s supplementary infant formula is frequently recommended by doctors. However, certain baby formula, particularly those manufactured for preterm infants by Enfamil and Similac, include high-calorie cow’s milk-based ingredients. Premature infants may be more susceptible to necrotizing enterocolitis as a result of several factors (NEC).

Studies show Necrotizing Enterocolitis Risk lowered by Mother’s Milk

1990: A study published in The Lancet titled “Breast milk and neonatal necrotizing enterocolitis” showed babies fed milk-based formula were 6-10 times more likely to develop NEC. In a prospective multi-centre study of 926 preterm infants formally assigned to their early diet, necrotizing enterocolitis developed in 51 (5·5%). Mortality was 26% in stringently confirmed cases. In exclusively formula-fed babies confirmed disease was 6-10 times more common than in those fed breast milk alone and 3 times more common than in those who received formula plus breast milk. Pasteurized donor milk seemed to be as protective as raw maternal milk. Among babies born at more than 30 weeks’ gestation confirmed necrotizing enterocolitis was rare in those whose diet included breast milk; it was 20 times more common in those fed formula only. Other risk factors included very low gestational age, respiratory disease, umbilical artery catheterization, and polycythemia. In formula-fed but not breast-milk-fed infants, delayed enteral feeding was associated with a lower frequency of necrotizing enterocolitis. With the fall in the use of breast milk in British neonatal units, exclusive formula feeding could account for an estimated 500 extra cases of necrotizing enterocolitis each year. About 100 of these infants would die.

2010: A study published in the Journal of Pediatrics found that infants fed with breast milk or human milk fortifiers were 90% less likely to develop NEC compared to those who were fed with traditional formula made from cow’s milk.

2011: A U.S. Surgeon General’s Call to Action to Support Breastfeeding announced that premature infants not fed human breast milk were 138% more likely to develop NEC.

2014: An Expert Review of Clinical Immunology  reviewed and noted scientific evidence that showed infants experienced higher rates of NEC when given formula compared to those who were fed breast milk. 

2016: Beyond Necrotizing Enterocolitis Prevention: Improving Outcomes with an Exclusive Human Milk-Based Diet details a breastfeeding medicine study of over 1,500 newborns. This study found a lower incidence of NEC in those who received only human breast milk. 

2019: A Cochrane study of more than 1,900 premature infants found that those who ingested cow-milk-based formulas experienced 7 times higher rates of NEC.

2021: A Journal of The American Academy of Pediatrics  study showed that premature infants given only human breast milk reduced their NEC risk by 77%.


  • Premature Infant Formula Lawsuit Update: April 2022
  • Abbott recalls Similac Infant Formulas
  • Infant Formula Lawsuit – Necrotizing Enterocolitis (NEC)
  • Abbott faces False Ad Claim in Similac Baby Food Suit

by Matthews & Associates

Share To:

Nationwide Legal Representation

  • Please enter your first name.
  • Please enter your last name.
  • Please enter your phone number.
    This isn't a valid phone number.
  • Please enter your email address.
    This isn't a valid email address.
  • Please make a selection.
  • Please enter a message.
  • By submitting, you agree to be contacted about your request & other information using automated technology. Message frequency varies. Msg & data rates may apply. Text STOP to cancel. Acceptable Use Policy
Locations (By Appt. Only)
  • Houston, TX - Principal Office
    2905 Sackett St.
    Houston, TX 77098
    Map & Directions
  • New York, NY
  • Salinas, CA
Follow Us