Evidence of low quality suggests that lactoferrin supplementation to enteral feeds with or without probiotics decreases late-onset sepsis and NEC stage II or III in preterm infants without adverse effects .
BACKGROUND Lactoferrin , a normal component of human colostrum and milk , can enhance host defenses and may be effective for prevention of sepsis and necrotizing enterocolitis ( NEC ) in preterm neonates .
To assess the safety and effectiveness of lactoferrin supplementation to enteral feeds for prevention of sepsis and NEC in preterm neonates Secondary objectives 1 .
To determine the effects of lactoferrin supplementation to enteral feeds to prevent neonatal sepsis and /or NEC on duration of positive-pressure ventilation , development of chronic lung disease ( CLD ) or periventricular leukomalacia ( PVL ) , length of hospital stay to discharge among survivors , and adverse neurological outcomes at two years of age or later2 .
To determine the adverse effects of lactoferrin supplementation for prophylaxis of neonatal sepsis and /or NECWhen data were available , we analyzed the following subgroups.1 .
Gestational age < 32 weeks and 32 to 36 weeks2 .
Type of feeding : breast milk versus formula milk SEARCH METHODS : We used the search strategy of the Cochrane Neonatal Review Group ( CNRG ) to up date our search in December 2016 .
Bovine lactoferrin supplementation for prevention of necrotizing enterocolitis in very-low-birth-weight neonates: a randomized clinical trial.
IMPORTANCE 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 several RCTs . OBJECTIVE Lactoferrin , a mammalian milk glycoprotein involved in innate immune host defences , can reduce the incidence of NEC in animal models , and its action is enhanced by LGG . We tried to assess whether bovine lactoferrin ( BLF ) , alone or with the probiotic LGG , has a similar effect in human infants , something that has not yet been studied . DESIGN An international , multicenter , r and omized , double-blind , placebo-controlled trial conducted from October 1st , 2007 through July 31st , 2010 . SETTING Thirteen Italian and New Zeal and tertiary neonatal intensive care units . PARTICIPANTS 743 VLBW neonates were assessed until discharge for development of NEC . INTERVENTION Infants were r and omly assigned to receive orally either BLF ( 100 mg/day ) alone ( group LF ; n = 247 ) or with LGG ( at 6 × 10(9 ) CFU/day ; group BLF + LGG ; n = 238 ) , or placebo ( Control group ; n = 258 ) from birth until day 30 of life ( 45 for neonates < 1000 g at birth ) . MAIN OUTCOME MEASURES ≥ stage 2 NEC ; death- and /or-≥ stage 2 NEC prior to discharge . RESULTS 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 [ 5/247 ( 2.0 % ) ] and 0/238 ( 0 % ) , respectively ] than in controls [ 14/258 ( 5.4 % ) ] ( RR = 0.37 ; 95 % CI : 0.136 - 1.005 ; p = 0.055 for BLF vs. control ; RR = 0.00 ; p < 0.001 for BLF + LGG vs. control ) . The incidence of death- and /or-NEC was significantly lower in both treatment groups ( 4.0 % and 3.8 % in BLF and BLF + LGG vs. 10.1 % in control ; RR = 0.39 ; 95 % CI : 0.19 - 0.80 ; p = 0.008 . RR = 0.37 ; 95 % CI : 0.18 - 0.77 ; p = 0.006 , respectively ) . No adverse effects or intolerances to treatment occurred . CONCLUSIONS AND RELEVANCE Compared with placebo , BLF supplementation alone or in combination with LGG reduced the incidence of ≥ stage 2 NEC and of death- and /or ≥ stage 2 NEC in VLBW neonates . BLF might be a promising strategy to prevent NEC in NICU setting s. Further data on larger sample sizes are warranted before BLF can be widespreadly used in clinical setting s. TRIAL REGISTRATION IS RCT N53107700-http://www.controlled-_trials.com/IS RCT N53107700
Evidence of low quality suggests that lactoferrin supplementation to enteral feeds with or without probiotics decreases late-onset sepsis and NEC stage II or III in preterm infants without adverse effects .
BACKGROUND Lactoferrin , a normal component of human colostrum and milk , can enhance host defenses and may be effective for prevention of sepsis and necrotizing enterocolitis ( NEC ) in preterm neonates .
To assess the safety and effectiveness of lactoferrin supplementation to enteral feeds for prevention of sepsis and NEC in preterm neonates Secondary objectives 1 .
To determine the effects of lactoferrin supplementation to enteral feeds to prevent neonatal sepsis and /or NEC on duration of positive-pressure ventilation , development of chronic lung disease ( CLD ) or periventricular leukomalacia ( PVL ) , length of hospital stay to discharge among survivors , and adverse neurological outcomes at two years of age or later2 .
To determine the adverse effects of lactoferrin supplementation for prophylaxis of neonatal sepsis and /or NECWhen data were available , we analyzed the following subgroups.1 .
Gestational age < 32 weeks and 32 to 36 weeks2 .
Type of feeding : breast milk versus formula milk SEARCH METHODS : We used the search strategy of the Cochrane Neonatal Review Group ( CNRG ) to up date our search in December 2016 .