- Copyright © 2002 by the American Academy of Pediatrics
The U.S. Centers for Disease Control and Prevention (CDC) is recommending that milk-based powdered infant formulas not be used in neonatal intensive care units unless no alternative is available.
The warning does not apply to healthy full-term infants at home and does not involve the use of liquid infant formula in the hospital or home.
The recommendation follows an investigation by the CDC of a fatal Enterobacter sakazakii meningitis case in a premature infant in a neonatal intensive care unit. The CDC concluded that the infection was associated with the presence of the organism in commercial powdered formula fed to the infant (U.S. Centers for Disease Control and Prevention. MMWR. 2002;51:298-300OpenUrl). Working with the U.S. Food and Drug Administration, the manufacturer has recalled the implicated batch of formula (see Health Alerts, page 239).
The CDC pointed out that powdered formulas are not commercially sterile products and may contain low levels of bacterial pathogens such as E. sakazakii. This bacterium is a rare cause of invasive disease, such as meningitis, sepsis and necrotizing enterocolitis, particularly in premature or immunocompromised infants.
If a powdered formula must be fed to premature infants or other infants with weakened immune systems, the CDC offers the following recommendations to minimize risks of infection:
Formula products should be selected based on nutritional needs; alternatives to powdered forms should be chosen when possible.
Trained personnel should prepare powdered formula under aseptic technique in a designated preparation room.
Manufacturer’s instructions should be followed; product should be refrigerated immediately and discarded if not used within 24 hours after preparation.
The administration or “hang” time for continuous enteral feeding should not exceed four hours.
Written hospital guidelines should be available in the event of a manufacturer product recall, including notification of health care providers, a system for reporting and follow-up of specific formula products used and retention of recall records.
Health care providers should report invasive disease in infants due to E. sakazakii, particularly bloodstream infection or meningitis with onset in the health care setting, to state health departments and the CDC at (800) 893-0485. Adverse events associated with infant formula should be reported to the U.S. Food and Drug Administration’s MedWatch program at (800) 332-1088 or www.fda.gov/medwatch.