Background Lactoferrin (LF) is a broad-spectrum antimicrobial and immunomodulatory milk glycoprotein. Objective To determine the effect of bovine LF on the prevention of the first episode of late-onset sepsis in Peruvian infants. Methods We conducted a pilot randomized placebo-controlled double blind study in infants with a birth weight <2500g in three Neonatal Units in Lima. Patients were randomized to receive bovine LF 200mg/kg/day or placebo for four weeks. Results 190 neonates with a birth weight of 1591±408g and a gestational age of 32.1±2.6wks were enrolled. Overall, 33 clinically-defined first late-onset sepsis events occurred. The cumulative sepsis incidence in the LF group was 12/95(12.6%) vs. 21/95(22.1%) in the placebo group, and 20% (8/40) vs. 37.5% (15/40) for infants ≤1500g. The hazard ratio of LF, after adjustment by birth weight, was 0.507 (95% CI, 0.249 to 1.034). There were 4 episodes of culture-proven sepsis in the LF group vs. 4 in the placebo group. Considering that children did not received the intervention until the start of oral or tube feeding, we ran a secondary exploratory analysis using time since the start of the treatment; in this model, LF achieved significance. There were no serious adverse events attributable to the intervention. Conclusions Overall sepsis occurred less frequently in the LF group than in the control group. Although the primary outcome did not reach statistical significance, the confidence interval is suggestive of an effect that justifies a larger trial.

Bronchopulmonary dysplasia incidence was 24.4% in a large South American population and is related to greater resource utilization. Risk factors for bronchopulmonary dysplasia in this study were: surfactant requirement, mechanical ventilation, airleak, patent ductus arteriosus, late onset sepsis and necrotizing enterocolitis. These studies may provide useful information in the design of effective preventive perinatal strategies.

No abstract

Preterm neonates are at risk to acquire infections. In addition to the high mortality associated with sepsis, these patients are at risk for long-term disabilities, particularly neurodevelopment impairment. Several interventions have been evaluated to reduce rates of infections in neonates but have not proven efficacy. Lactoferrin (LF), a milk glycoprotein with anti-inflammatory, immunomodulatory and anti-microbial properties, has the potential to prevent infections in young children. We performed a review of current and ongoing clinical trials of LF for prevention of neonatal sepsis, and found eleven registered clinical trials that include more than 6000 subjects. Few of these trials have finished; despite their small sample size, the preliminary results show a trend towards a positive protective effect of LF on neonatal infections. Larger trials are underway to confirm the findings of these initial studies. This information will help to define LF´s role in clinical settings and, if proven effective, would profoundly affect the treatment of low birth weight neonates as a cost-effective intervention worldwide.

Several cytokines have been detected in human milk but their relative concentrations differ among women and vary over time in the same person. The drivers of such differences have been only partially identified, while the effect of luminal cytokines in the fine-regulation of the intestinal immune system is increasingly appreciated. The aim of this study was to investigate the associations between obstetrical complications and human milk cytokine profiles in a cohort of Peruvian women giving birth to Low Birth Weight (LBW) infants. Colostrum and mature human milk samples were collected from 301 Peruvian women bearing LBW infants. The concentration of twenty-three cytokines was measured using the Luminex platform. Ninety-nine percent of women had at least one identified obstetrical complication leading to intra-uterine growth restriction and/or preterm birth. Median weight at birth was 1,420 grams; median gestational age 31 weeks. A core of 12 cytokines, mainly involved in innate immunity and epithelial cell integrity, was detectable in most samples. Maternal age, maternal infection, hypertensive disorders, preterm labor, and premature rupture of membranes were associated with specific cytokine profiles both in colostrum and mature human milk. Mothers of Very LBW (VLBW) neonates had significantly higher concentrations of chemokines and growth factor cytokines both in their colostrum and mature milk compared with mothers of larger neonates. Thus, maternal conditions affecting pregnancy duration and in utero growth are also associated with specific human milk cytokine signatures.