Randomized Controlled Trial of Lactoferrin for Prevention of Sepsis in Peruvian Neonates Less than 2500 g

Randomized controlled trial in neonates with birth weight under 2500 g admitted to neonatal units in Lima, Peru. For the lactoferrin arm, 95 participants were randomized, with block randomization 1:1 against placebo.

Bovine lactoferrin was given orally at 200 mg/kg/day in 3 divided doses for 4 weeks, starting at enrollment. Capsules were opened and mixed with feeds. The comparator was maltodextrin placebo.

Lactoferrin showed a lower rate of late-onset sepsis than placebo, but the primary outcome did not reach statistical significance. First late-onset sepsis occurred in 12/95 (12.6%) in the lactoferrin group versus 21/95 (22.1%) with placebo; the BW-adjusted hazard ratio was 0.507 (95% CI 0.249-1.034; P = 0.062). Mean age at first sepsis was 6.3 days with lactoferrin versus 9.5 days with placebo. No serious adverse events were attributable to lactoferrin.

The trial was relatively small and the primary endpoint was not statistically significant. Treatment lasted only 4 weeks, and some analyses were exploratory, which limits confidence in the estimated benefit. Per-arm baseline demographic detail was limited, and generalizability is restricted to low birth weight neonates in Lima, Peru.