BACKGROUND: NEC is a common and severe complication in premature neonates, particularly those with very-low-birth-weight (VLBW, <1500 g at birth). Probiotics including Lactobacillus rhamnosus GG (LGG) proved effective in preventing NEC in preterm infants in RCTs. Lactoferrin, a mammalian milk glycoprotein involved in innate immune host defenses, can reduce the incidence of NEC in animal models, and its action is enhanced by LGG. The effect on NEC of bovine lactoferrin (BLF), alone or with the probiotic LGG, has not yet been studied in human infants. OBJECTIVE: To establish whether bovine lactoferrin alone or with LGG, reduces the incidence of NEC in VLBW neonates. DESIGN/METHODS: This was an international, multicenter, randomized, double-blind, placebo-controlled trial. Thirteen Italian and New Zealand tertiary neonatal intensive care units screened and enrolled preterm, VLBW infants from October 1, 2007 through October 31, 2010. Infants were randomly assigned to receive orally either bLF (100mg/day) alone (group LF; n=251) or with LGG (at 6x109 CFU/day; group LF+LGG; n=242), or placebo (Control group; n=259) from birth until day 30 of life (45 for neonates <1000g at birth). The main outcome measures were NEC greater than stage 2, and NEC (any stage). RESULTS: 825 VLBW neonates were enrolled and assessed until discharge for development of NEC.Demographics, clinical and management characteristics of the 3 groups were similar, including type of feeding and maternal milk intakes. NEC incidence was significantly lower in groups BLF and BLF+LGG [5/251 (2.0%) and 1/242 (0.4%), respectively] than in controls [14/259 (5.4%)] (R.R. 0.35; 95% C.I. 0.13-0.99; p=0.04 for BLF vs. control; R.R 0.07; 95% C.I. 0.01-0.55; p=0.001 for BLF+LGG vs.control). The decrease occurred both for surgical and low-stages NECs. No adverse effects or intolerances to treatment occurred. CONCLUSIONS: Compared with placebo, BLF supplementation alone or in combination with LGG reduces the incidence of NEC of any stage in VLBW neonates
Bovine Lactoferrin Supplementation for Prevention of Necrotizing Enterocolitis in Preterm Very-Low-Birth-Weight Neonates : A Randomized Trial / P. Manzoni, M. Rinaldi, M. Meyer, E. Della Casa, L. Pugni, F. Mosca, I. Stolfi, H. Messner, L. Memo, N. Laforgia, L. Decembrino, P.M. Betta, F. Vagnarelli, M. Stronati, D. Farina. ((Intervento presentato al convegno Pediatric Academic Societies tenutosi a Denver nel 2011.
Bovine Lactoferrin Supplementation for Prevention of Necrotizing Enterocolitis in Preterm Very-Low-Birth-Weight Neonates : A Randomized Trial
F. Mosca;
2011
Abstract
BACKGROUND: NEC is a common and severe complication in premature neonates, particularly those with very-low-birth-weight (VLBW, <1500 g at birth). Probiotics including Lactobacillus rhamnosus GG (LGG) proved effective in preventing NEC in preterm infants in RCTs. Lactoferrin, a mammalian milk glycoprotein involved in innate immune host defenses, can reduce the incidence of NEC in animal models, and its action is enhanced by LGG. The effect on NEC of bovine lactoferrin (BLF), alone or with the probiotic LGG, has not yet been studied in human infants. OBJECTIVE: To establish whether bovine lactoferrin alone or with LGG, reduces the incidence of NEC in VLBW neonates. DESIGN/METHODS: This was an international, multicenter, randomized, double-blind, placebo-controlled trial. Thirteen Italian and New Zealand tertiary neonatal intensive care units screened and enrolled preterm, VLBW infants from October 1, 2007 through October 31, 2010. Infants were randomly assigned to receive orally either bLF (100mg/day) alone (group LF; n=251) or with LGG (at 6x109 CFU/day; group LF+LGG; n=242), or placebo (Control group; n=259) from birth until day 30 of life (45 for neonates <1000g at birth). The main outcome measures were NEC greater than stage 2, and NEC (any stage). RESULTS: 825 VLBW neonates were enrolled and assessed until discharge for development of NEC.Demographics, clinical and management characteristics of the 3 groups were similar, including type of feeding and maternal milk intakes. NEC incidence was significantly lower in groups BLF and BLF+LGG [5/251 (2.0%) and 1/242 (0.4%), respectively] than in controls [14/259 (5.4%)] (R.R. 0.35; 95% C.I. 0.13-0.99; p=0.04 for BLF vs. control; R.R 0.07; 95% C.I. 0.01-0.55; p=0.001 for BLF+LGG vs.control). The decrease occurred both for surgical and low-stages NECs. No adverse effects or intolerances to treatment occurred. CONCLUSIONS: Compared with placebo, BLF supplementation alone or in combination with LGG reduces the incidence of NEC of any stage in VLBW neonates
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