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 .
Randomized Controlled Trial of Talactoferrin Oral Solution in Preterm Infants.
OBJECTIVE To evaluate the safety and explore the efficacy of recombinant human lactoferrin ( talactoferrin [ TLf ] ) to reduce infection . STUDY DESIGN We conducted a r and omized , double blind , placebo-controlled trial in infants with birth weight of 750 - 1500 g. Infants received enteral TLf ( n = 60 ) or placebo ( n = 60 ) on days 1 through 28 of life ; the TLf dose was 150 mg/kg every 12 hours . Primary outcomes were bacteremia , pneumonia , urinary tract infection , meningitis , and necrotizing enterocolitis ( NEC ) . Secondary outcomes were sepsis syndrome and suspected NEC . We recorded clinical , laboratory , and radiologic findings , along with diseases and adverse events , in a data base used for statistical analyses . RESULTS Demographic data were similar in the 2 groups of infants . We attributed no enteral or organ-specific adverse events to TLf . There were 2 deaths in the TLf group ( 1 each due to posterior fossa hemorrhage and postdischarge sudden infant death ) , and 1 death in the placebo group , due to NEC . The rate of hospital-acquired infections was 50 % lower in the TLf group compared with the placebo group ( P < .04 ) , including fewer blood or line infections , urinary tract infections , and pneumonia .  Fourteen infants in the TLf group weighing < 1 kg at birth had no gram-negative infections , compared with only 3 of 14 such infants in the placebo group . Noninfectious outcomes were not statistically significantly different between the 2 groups , and there were no between-group differences in growth or neurodevelopment over a 1-year posthospitalization period . CONCLUSION We found no clinical or laboratory toxicity and a trend toward less infectious morbidity in the infants treated with TLf . TRIAL REGISTRATION Clinical Trials.gov : NCT00854633
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 .