G2-1277. A Multicenter, Randomized Trial on Prophylactic Bovine Lactoferrin in Preterm Neonates for Prevention of Late-Onset Sepsis
Session: Poster Session: Pediatrics I
Sunday, October 26, 2008: 12:00 AM
Room: Hall C
Background: Lactoferrin (LF) is a mammalian milk glycoprotein that plays a major role in innate immune host defenses, with multiple biological (including anti-infective) properties. In animal models, its activity has been found emphasized by the combination with Lactobacillus RhamnosusGG (LGG). We performed a multicenter, double-blind, placebo-controlled RCT to assess effectiveness and safety of prophylactic LF supplementation (alone or in combination with LGG) to preterm neonates in NICU for prevention of late-onset sepsis (LOS). Methods: For 8 months, all preterm VLBW neonates from 11 italian NICUs were randomized to receive orally, once a day, since birth and for 30 days, either Bovine LF alone (100 mg/day, gr.A1; n=111) or in combination with LGG (6 x 109 CFU/day, A2; n=118), or placebo (B, n=125). Systematic surveillance for detection of sepsis and adverse effects was performed. LOS was defined as episodes occurring >5days after birth, and microbiologically confirmed by isolation of a pathogen (any type) from blood, urine, peritoneal and cerebrospinal fluid. Results: 354 neonates were analysed. Their clinical, demographical and management characteristics did not differ, particularly related to type of feeding and amounts of maternal milk intakes. Overall, LOS incidence was significantly lower in groups A1 and A2 (10.7% and 9.8% respectively) than in B (26.7%) (R.R. 0.32; 95% C.I. 0.16-0.68; p=0.02 in A1; R.R 0.29; 95% C.I. 0.15-0.59; p=0.001 in A2). The decrease in LOS incidence was similar for all agents (Gram-pos.,Gram-neg., fungal organisms). No adverse effects or intolerances occurred. Conclusions: Bovine LF (alone, or in combination with LGG) orally administered to preterm VLBW neonates significantly and safely reduces the incidence of LOS.
D. Farina, MD, Sant'Anna Hospital, F. Vagnarelli, MD, Arcispedale, I. Stolfi, MD, Umberto I^Hospital, L. Memo, MD, Ca'Foncello H., L. Bollani, MD, IRCCS S.Matteo, M. Betta, MD, University, N. Laforgia, MD, Policlinico, Paolo Manzoni, MD, Sant'Anna Hospital, Torino, Italy and  P. Manzoni,
Dicofarm S.p.a. Role(s): Grant Investigator, Received: Research Grant.

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