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A Controlled Mouse Model for Neonatal Polymicrobial Sepsis
Published on: January 27, 2019
Randomized controlled trial of lactoferrin for prevention of sepsis in peruvian neonates less than 2500 g
Theresa J Ochoa1, Jaime Zegarra, Luis Cam
1From 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.
Insights
Bovine lactoferrin (LF) supplementation may reduce late-onset sepsis in Peruvian infants. While not statistically significant, the results suggest LF warrants further investigation in larger clinical trials for neonatal sepsis prevention.
Area of Science:
- Neonatal Medicine
- Immunology
- Microbiology
Background:
- Lactoferrin (LF) is a glycoprotein found in milk with antimicrobial and immunomodulatory properties.
- Late-onset sepsis is a significant concern in preterm and low birth weight infants.
Purpose of the Study:
- To evaluate the efficacy of bovine lactoferrin (LF) in preventing the first episode of late-onset sepsis in Peruvian infants.
- To assess the safety of bovine LF supplementation in this vulnerable population.
Main Methods:
- A pilot, randomized, placebo-controlled, double-blind study was conducted.
- Infants with birth weight < 2500g received either bovine LF (200mg/kg/d) or placebo for 4 weeks.
- Sepsis events and adverse events were monitored.
Main Results:
- A total of 190 neonates were enrolled.
- The cumulative incidence of sepsis was lower in the LF group (12.6%) compared to the placebo group (22.1%).
- An exploratory analysis adjusting for treatment start time indicated a significant protective effect of LF.
Conclusions:
- Bovine LF supplementation resulted in a lower incidence of overall sepsis in the neonates studied.
- Although the primary outcome did not reach statistical significance, the observed trend suggests LF may be beneficial.
- A larger clinical trial is recommended to confirm the efficacy of LF in preventing neonatal sepsis.
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.
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