title: Randomized controlled trial of lactoferrin for prevention of sepsis in peruvian neonates less than 2500 g.
abstract: 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 (BW) less than 2500g in 3 Neonatal Units in Lima. Patients were randomized to receive bovine LF 200mg/kg/d or placebo for 4 weeks.
  
  
  RESULTS
  One hundred and ninety neonates with a BW of 1591 ± 408 g and a gestational age of 32.1 ± 2.6 weeks 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%) versus 21/95 (22.1%) in the placebo group, and 20% (8/40) versus 37.5% (15/40) for infants less than or equal to 1500 g. The hazard ratio of LF, after adjustment by BW, was 0.507 (95% CI: 0.249-1.034). There were 4 episodes of culture-proven sepsis in the LF group versus 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.
authors.affiliation: From the *Instituto de Medicina Tropical "Alexander von Humboldt", Universidad Peruana Cayetano Heredia, Lima, Peru; †Department of Pediatrics, Universidad Peruana Cayetano Heredia, Lima, Peru; ‡Center for Infectious Diseases, University of Texas School of Public Health, Houston, Texas; §Hospital Nacional Cayetano Heredia, Lima, Peru; ¶Hospital Nacional Alberto Sabogal Sologuren, Lima, Peru; ‖Hospital Nacional Guillermo Almenara Irigoyen, Lima, Peru; **Department of Public Health, Universidad Peruana Cayetano Heredia, Lima, Peru; and ††Department of Mathematics, Universidad Peruana Cayetano Heredia, Lima, Peru.
authors.forename: Theresa J
authors.initials: TJ
authors.lastname: Ochoa
authors.forename: Jaime
authors.initials: J
authors.lastname: Zegarra
authors.forename: Luis
authors.initials: L
authors.lastname: Cam
authors.forename: Raul
authors.initials: R
authors.lastname: Llanos
authors.forename: Alonso
authors.initials: A
authors.lastname: Pezo
authors.forename: Karen
authors.initials: K
authors.lastname: Cruz
authors.forename: Alonso
authors.initials: A
authors.lastname: Zea-Vera
authors.forename: Cesar
authors.initials: C
authors.lastname: Cárcamo
authors.forename: Miguel
authors.initials: M
authors.lastname: Campos
authors.forename: Sicilia
authors.initials: S
authors.lastname: Bellomo
mesh_terms: D000890:Anti-Infective Agents / Q000008:administration & dosage*; D004311:Double-Blind Method; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage*; D007231:Infant, Newborn; D007781:Lactoferrin / Q000008:administration & dosage*; D010568:Peru; D010865:Pilot Projects; D010919:Placebos / Q000008:administration & dosage; D018805:Sepsis / Q000517:prevention & control*; D016896:Treatment Outcome
chemical_list: D000890:Anti-Infective Agents; D007155:Immunologic Factors; D010919:Placebos; D007781:Lactoferrin