By Serena Gordon
TUESDAY, Oct. 6 (HealthDay News) -- A protein from cow's milk could reduce by about two-thirds the rate of serious blood infections in babies born weighing less than 3.3 pounds.
That's the conclusion of a study published in the Oct. 7 issue of the Journal of the American Medical Association that found when these tiny newborns were given a daily dose of the milk protein lactoferrin along with a probiotic bacteria during the first weeks of life, the incidence of the blood infection sepsis dropped dramatically.
"Prevention of sepsis in neonates can be achieved through supplementation of a simple, easily available, cost-effective intervention that is well-tolerated and may be implemented in all settings, including Third World [countries]," said study author Dr. Paolo Manzoni, a neonatologist at S. Anna Hospital in Torino, Italy.
However, when isolated from milk and then concentrated -- as it was in this study -- bovine lactoferrin is not yet approved for use in the United States.
"The biggest hurdle if I was to use this, is that it's not FDA-approved," said the author of an accompanying editorial in the same issue of the journal, Dr. David Kaufman, assistant medical director of the neonatal intensive care unit at the University of Virginia Medical School in Charlottesville.
"Preventive strategies in these infants are really critical. Many preterm babies don't survive because of infection. I hope this treatment gets fast-tracked for approval, because this is a big effect from what seems like a safe and minimal intervention," said Kaufman.
Because bovine lactoferrin is naturally found in cow's milk, Manzoni said the researchers don't expect any long-term safety problems. Lactoferrin is also found in breast milk, but because of the concentrations needed, has to be genetically engineered, making it more expensive, according to Manzoni.
The current study included 472 Italian newborns who weighed less than 3.3 pounds (1,500 grams) at birth. Doctors classify these infants as "very low birth weight." Within this category, a baby who weighs less than 2.2 pounds (1,000 grams) at birth, may also be classified as "extremely low birth weight." Generally, such tiny infants are also born prematurely.
The babies were randomly assigned to one of three groups: a control group that received a placebo, a group that was given 100 milligrams (mg) daily of bovine lactoferrin, and a group that was given 100 mg of bovine lactoferrin plus the probiotic Lactobacillus rhamnosus GG. The addition of the probiotic is believed to enhance the antibacterial and antifungal properties of lactoferrin, according to the study. Treatment continued for 30 days with the very low birth weight infants and for 45 days for the extremely low birth weight infants.
The incidence of late-onset (after a baby is 72 hours old) sepsis in the control group was 17.3 percent compared to 5.9 percent in the group receiving lactoferrin. The babies who received lactoferrin plus the probiotic fared best of all, with just 4.6 percent developing sepsis.
In his editorial, Kaufman pointed out that the smallest babies had even better results, and suggested that by increasing the dose and length of treatment in the babies who were a little heavier, the results might be even better.
He explained that in these small infants, the lining of the gastrointestinal tract is often underdeveloped, which can allow bacteria to migrate from the digestive system into the bloodstream, causing infection. Lactoferrin helps kill bacteria and fungi, first in the stomach and then in the gastrointestinal tract.
"That makes the mucosal lining barrier stronger and keeps bacteria from moving from the gut into the bloodstream," Kaufman explained.
An added benefit to this treatment, noted Manzoni, is that it could reduce the use of antibiotics as well.
Learn more about infections and other possible complications that can occur in premature infants from the Nemours Foundation.
SOURCES: Paolo Manzoni, M.D., neonatalogist, S. Anna Hospital, and coordinator, Italian Network for the Study of Neonatal Infections, and, chairman, scientific committee, Neonatalogy Foundation, S. Anna Hospital, Torino, Italy; David Kaufman, M.D., associate professor, pediatrics, assistant medical director, neonatal intensive care unit, and director, the Neonatal Clinical Trials Unit, University of Virginia Medical School, Charlottesville, Va.; Oct. 7, 2009, Journal of the American Medical Association
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