Bovine lactoferrin supplementation for prevention of late-onset sepsis in very low birthweight neonates

The incidence of sepsis in premature neonates of very low birth weight (<1.5kg) is high and can be fatal. Sepsis is an overwhelming and overcompensating response of the immune system to a pathogen such as Staphylococcus aureus, and has a high mortality rate if it progresses to septic shock. Multiple organ failure often occurs as a result due to inadequate perfusion to vital organs. There have been many attempts to reduce the incidence of late-onset sepsis as infections are currently the most common cause of death in premature infants. One in five very low birth weight neonates will develop sepsis, as the digestive tract is susceptible to colonization by many pathogens,

Lactoferrrin is a major whey protein found in mammalian milk and plays a role in the immune system. The highest levels of lactoferrin can be found in human colostrums, the breast milk that is produced for a few days after childbirth. However, the composition of bovine lactoferrin is similar to human lactoferrin.

This randomized trial aimed to study if bovine lactoferrin with or without Lactobacillus rhamnosus GG (LGG) could reduce the incidence of late-onset sepsis (occurring >72 hrs after birth) in this vulnerable group. The infants were divided into 3 groups; the first received bovine lactoferrin (100mg/d) only (n=153). The second group (n=151) received bovine lactoferrin at the same dose and LGG (6 x 109 CFU/day). The third group received a placebo (n=168). All treatments and placebo were given orally, from birth until 30 days or day 45 for neonates born <1kg at birth.

There was a lower incidence in the two bovine lactoferrin groups compared to the control group (5.9% and 4.6% vs 18.3%; risk ratio 0.34; 95% confidence interval: 017-0.,2, P<0.01). No adverse reactions to bovine lactoferrin were reported.

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Manzoni, P., et al., Bovine lactoferrin supplementation for prevention of late-onset sepsis in very low-birth-weight neonates: a randomized trial. JAMA, 2009. 302(13): p. 1421-8.

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