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(Ivanhoe Newswire) -- Very low birth-weight (VLBW) newborns who received the milk protein lactoferrin alone or in combination with a probiotic had a reduced incidence of late-onset sepsis, according to a new study.
"Infections are the most common cause of death in premature infants and a major threat for poor outcomes," study authors are quoted as saying.
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Late onset sepsis occurs during the first four weeks after birth, usually in the hospital, and affects 21 percent of VLBW newborns (less than 3.3 lbs). Bovine lactoferrin (BLF; a milk glycoprotein) inhibits the growth of a wide variety of bacteria, fungi, and viruses and exhibits even higher in vitro antimicrobial activity than human lactoferrin. In animal tests, the probiotic Lactobacillus rhamnosus GG (LGG) improved the activity of lactoferrin, but it has not been studied in infants.
Paolo Manzoni, M.D., of S. Anna Hospital in Torino, Italy, and colleagues examined whether oral supplementation with BLF alone or in combination with LGG reduces late-onset sepsis in VLBW infants. The randomized trial was conducted in 11 Italian neonatal intensive care units and included 472 infants who were assessed until discharge for development of sepsis. Infants were randomly assigned to receive orally administered BLF alone, BLF plus LGG, or placebo from birth until day 30 of life. Demographic, clinical and management characteristics of the three groups were similar, including type of feeding and intake of maternal milk.
Forty-five infants in the study group had an episode of late-onset sepsis. The researchers found late-onset sepsis occurred less frequently in the BLF and BLF plus LGG groups. The decrease occurred for bacterial as well as fungal episodes. The sepsis-attributable risk of death was significantly lower in the two treatment groups. No adverse effects to treatment occurred.
"Prevention of neonatal sepsis relies on hygiene measures, cautious use of invasive procedures, medication stewardship, administration of fresh maternal milk, and early diagnosis, the authors concluded. Nevertheless, none of these interventions is fully effective in decreasing the burden of the disease and overall have not been subjected to randomized controlled trials. This study has demonstrated that supplemental BLF, either alone or in combination with LGG, reduces first episodes of late-onset sepsis in VLBW infants."
In an accompanying editorial, David A. Kaufman, M.D., of the University of Virginia Health System in Charlottesville, writes that while this study provides important information, more research is needed.
"The results of the current study by Manzoni et al provide the opportunity to make further research on lactoferrin a priority," Dr. Kaufman wrote. "Future research should be directed at confirming the safety and efficacy of lactoferrin in VLBW infants, including more extremely preterm infants, because they potentially will benefit the most from lactoferrin. Combination strategies, such as the use of BLF plus LGG in the study by Manzoni et al, should be pursued, and substances that might affect lactoferrin activity, such as iron supplementation, should be investigated. The effect of lactoferrin on hematocrit [the proportion of blood that consists of packed red blood cells] should be monitored, and the effects of lactoferrin on neurodevelopmental outcome, hospital length of stay, and costs should be studied."
SOURCE: Journal of the American Medical Association (JAMA), October 7, 2009
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