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

Study answer

What this study found

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.

Study & population

Randomized controlled trial in neonates with birth weight under 2500 g admitted to neonatal units in Lima, Peru.

Intervention

Bovine lactoferrin was given orally at 200 mg/kg/day in 3 divided doses for 4 weeks, starting at enrollment.

Key limitation

The trial was relatively small and the primary endpoint was not statistically significant.

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Original abstract