Abstract
Premature infants are at high risk for diseases associated with impaired adaptation of the immature digestive tract, such as necrotizing enterocolitis (NEC) or late-onset sepsis (LOS), as well as severe neonatal morbidities associated with these diseases. This study was aimed to evaluate the effectiveness of prophylactic enteral use of bovine lactoferrin for the prevention of severe neonatal diseases in premature infants. The prospective cohort study included 117 premature infants with gestational age (GA) of ≤32 weeks, a birth weight of ≤1,500 g, and an age of ≤72 hours. 27 infants who were receiving enteral feeds were randomized to receive lactoferrin at a dose of 100 mg/day until postmenstrual age (PMA) of 36 weeks or discharge (at least 4 weeks). 90 infants formed the control group and received standard treatment. The primary outcome was the incidence of LOS, the secondary outcomes were the incidence of necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), severe brain damage, bronchopulmonary dysplasia (BPD), overall mortality, as well as the age of achieving full enteral feeds, duration of antibacterial therapy, length of stay in NICU and the total length of hospital stay. Enteral lactoferrin supplementation did not reduce the incidence of LOS (29.6% in the lactoferrin group against 22.7% in the control group; p=0.85), NEC (5.6% vs. 1.8%, respectively; p=0.11) and overall mortality (18.5% vs. 9.1%, respectively; p=0.06), as well as the incidence of severe intraventricular hemorrhages (18.5% vs. 9.8%, respectively; p=0.17), PVL (11.1% vs. 2.2%, respectively; p=0.17) and BPD (14.8% vs. 25.6%, respectively; p = 0.25). Infants receiving lactoferrin were achieving full enteral feeds significantly faster compared to the control group (14 (10-17) days vs. 19 (13-32) days, respectively; p=0.007). The total length of hospital stay of infants with GA ≤28 weeks in the lactoferrin group was significantly shorter compared to the control group (74 (68-89) vs. 98 (83-109) days, respectively; p=0.048). Enteral lactoferrin supplementation at a dose of 100 mg/day does not affect the main morbidity and mortality of prematurely born infants with GA ≤ 32 weeks but may facilitate significantly faster achievement of the full enteral feeds and the reduction of the length of hospital stay in the tiniest infants.
