The US Food and Drug Administration (FDA) has warned of the risk from Enterobacter sakazakii infections in hospitalised newborn infants fed powdered infant formulas.
The warning follows the case of a newborn death from E. sakazakii, which may be linked to a specific powdered infant formula, according to a recent report by the Centers for Disease Control and Prevention (CDC).
The formula, Portagen, is recommended by its manufacturers, Mead Johnson Nutritionals, for infants unable to absorb nutrients efficiently, and is intended for use under the supervision of a healthcare professional. The suspect batch of Portagen has been recalled by the company.
E. sakazakii can cause necrotising enterocolitis, sepsis and meningitis, and is known to have led to the death of a male baby born one month prematurely by Caesarean section. The child was found to have the bacterium present in his cerebrospinal fluid and, despite treatment with antibiotics for meningitis, he died nine days later.
It was later discovered that a further nine infants in the same unit were also infected by the bacterium, and all ten children were found to have received the formula product Portagen. A further 21 of the 40 infants who were not infected had also been fed Portagen.
During the investigation, the CDC researchers cultured the sterile water used to prepare the formula, as well as swabs from the surfaces on which the product was prepared and samples of the formula from opened and unopened tins of the same batch used during the period in question.
The team found that cultures from the cerebrospinal fluid of the dead infant matched cultures from both opened and unopened tins of formula. They concluded that the use of the milk-based formula was a probable factor in the child's infection. The hospital has since started using liquid formula.
The CDC said that the decision whether or not to use formula products should be based on nutritional needs and that alternatives to powdered forms should be chosen whenever possible. Powdered formulas should be prepared by trained personnel using an aseptic technique and following the manufacturers' guidelines.
Once prepared, the formula should be refrigerated immediately and discarded if unused within 24 hours. Administration time for enteral feeding should not exceed four hours.