Editor's note: The final report was released Sept. 16 and is available here.
A federal panel including AAP experts is calling for more research to understand causes, risk factors and nutritional support related to necrotizing enterocolitis (NEC) in premature infants.
NEC is one of the leading causes of illness and death among preterm infants and was responsible for the deaths of 356 infants in 2022, according to the Centers for Disease Control and Prevention. The efforts to identify research gaps come as recent lawsuits threaten the availability of specialty formulas that provide important nutrition for preterm infants.
The National Advisory Child Health and Human Development Council's NEC working group presented research recommendations Thursday and will send its final report to the secretary of the U.S. Department of Health and Human Services by Sept. 16. The working group is co-chaired by Yvonne “Bonnie” Maldonado, M.D., FAAP, a member of the AAP Section on Infectious Diseases, and Ravi M. Patel, M.D., M.Sc., FAAP, a member of the AAP Section on Neonatal-Perinatal Medicine Executive Committee. They are among several pediatricians on the panel.
The group made three overarching recommendations.
- Expand research into preventing premature birth.
- Develop more specific definitions of NEC and severity of NEC to improve epidemiological studies and determine eligibility for trials and treatments.
- Ensure that research on NEC incorporates the perspectives of affected families.
The group recommended more research on mechanisms of NEC development, exposures and feeding practices that may impact risk, optimal nutritional needs of premature infants and ways to reduce disparities in availability of human milk.
In addition, it called for innovative methods of collecting data and conducting trials, improved tracking of NEC cases and deaths, improved animal models and standardized procedures for donor milk.
The panel’s recommendations come just over a month after a jury ordered specialty formula maker Abbott Laboratories to pay $495 million in damages in one of numerous lawsuits against Abbott and another specialty formula manufacturer claiming the companies failed to warn families about the risk of NEC.
Specialty formulas and fortifiers provide an essential source of nutrition for premature infants. While breastmilk is preferred, it does not eliminate the risk of NEC, and there is not always enough supply from a parent or donors. The AAP is concerned NEC lawsuit verdicts may jeopardize the availability of specialty formulas.
“Courtrooms are not the best place to determine clinical recommendations for the care of infants,” AAP President Benjamin D. Hoffman, M.D., FAAP, said in a recent statement. “Feeding decisions should be made by clinicians and families. These need to be individualized in the context of human milk availability, specific patient needs, and individual family preferences.”
Resources
- Final report from the National Advisory Child Health and Human Development Council's NEC working group
- AAP statement in response to NEC lawsuit verdicts
- AAP patient care information on necrotizing enterocolitis
- Information for parents from HealthyChildren.org on necrotizing enterocolitis
- National Advisory Child Health and Human Development Council
- AAP clinical report Promoting Human Milk and Breastfeeding for the Very Low Birth Weight Infant
