Efficacy of Bovine Lactoferrin Supplementation in Preventing Late-onset Sepsis in low Birth Weight Neonates: A Randomized Placebo-Controlled Clinical Trial

J Trop Pediatr. 2015 Oct;61(5):370-6. doi: 10.1093/tropej/fmv044. Epub 2015 Jul 29.


Objectives: To evaluate the efficacy of bovine lactoferrin (BLF) in preventing first episode of late-onset sepsis (LOS) in low birth weight (LBW) neonates.

Methods: In this study conducted from May 2012 to July 2013 in the neonatal intensive care unit (NICU) of a tertiary care hospital, inborn asymptomatic neonates, <2000 g, admitted to NICU in first 12 h of birth with no maternal risk factors for sepsis were randomized to receive BLF or placebo from 1st to 28th day of life. The incidence of culture-proven sepsis and sepsis-attributable mortality after 72 h of life was recorded. Increasing doses of BLF were used with higher birth weights.

Results: Incidence of first episode of culture-proven LOS was significantly lower in the BLF group vs. placebo [2/63 (3.2%) vs. 9/67(13.4%); risk ratio, 0.211; 95% CI, 0.044-1.019; p = 0.036]. Statistically significant reduction in the sepsis-attributable mortality was also seen after use of prophylactic BLF [0/63 (0%) vs. 5/67 (7.5%); p = 0.027].

Conclusion: BLF supplementation in LBW neonates reduced the incidence of first episode of LOS.

Keywords: bovine lactoferrin; late-onset sepsis; low birth weight.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Animals
  • Anti-Infective Agents / administration & dosage*
  • Cattle
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Humans
  • Incidence
  • India / epidemiology
  • Infant, Low Birth Weight*
  • Infant, Newborn
  • Infant, Premature
  • Infant, Premature, Diseases / mortality
  • Infant, Premature, Diseases / prevention & control*
  • Intensive Care Units, Neonatal
  • Lactoferrin / administration & dosage*
  • Male
  • Risk Factors
  • Sepsis / mortality
  • Sepsis / prevention & control*
  • Treatment Outcome


  • Anti-Infective Agents
  • Lactoferrin