Trial reportThe Pediatric infectious disease journal2015
Randomized controlled trial of lactoferrin for prevention of sepsis in peruvian neonates less than 2500 g.
Trial report in The Pediatric infectious disease journal, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01525316 (Lactoferrin for Prevention of Sepsis in Infants), which is not on this map. Cited by 47 papers, 6 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Lactoferrin for Prevention of Sepsis in Infants
Who cites it
47 citing papers in PubMed, 6 syntheses or guidelines pooled it, 86 citations in OpenAlex.
- Prevention and Treatment of Neonatal Infections in Facility and Community Settings of Low- and Middle-Income Countries: A Descriptive Review.Neonatology · 2025Pooled it
- Neonatal sepsis definitions from randomised clinical trials.Pediatric research · 2023Pooled it
- The Impact of Interventions to Prevent Neonatal Healthcare-associated Infections in Low- and Middle-income Countries: A Systematic Review.The Pediatric infectious disease journal · 2022Pooled it
- Enteral lactoferrin supplementation for prevention of sepsis and necrotizing enterocolitis in preterm infants.The Cochrane database of systematic reviews · 2020Pooled it
- Pooled it
- Enteral lactoferrin supplementation for prevention of sepsis and necrotizing enterocolitis in preterm infants.The Cochrane database of systematic reviews · 2017Pooled it
- Effect of a high-dose bioactive components formula on reducing common diseases in term neonates delivered by cesarean section: a randomized, open-label, controlled trial.Frontiers in nutrition · 2026Trial
- Preventing Sepsis in Preterm Infants with Bovine Lactoferrin: A Randomized Trial Exploring Immune and Antioxidant Effects.Nutrients · 2025Trial
- Effect of Lactoferrin on Clinical Outcomes of Hospitalized Patients with COVID-19: The LAC Randomized Clinical Trial.Nutrients · 2023Trial
- Gut priming with bovine colostrum and T regulatory cells in preterm neonates: a randomized controlled trial.Pediatric research · 2021Trial
- Randomized Controlled Trial of Bovine Lactoferrin for Prevention of Sepsis and Neurodevelopment Impairment in Infants Weighing Less Than 2000 Grams.The Journal of pediatrics · 2020Trial
- Trial
- Lactoferrin concentration in breast milk of mothers of low-birth-weight newborns.Journal of perinatology : official journal of the California Perinatal Association · 2017Trial
- Randomized Controlled Trial of Talactoferrin Oral Solution in Preterm Infants.The Journal of pediatrics · 2016Trial
- The Lacuna Trial: a double-blind randomized controlled pilot trial of lactoferrin supplementation in the very preterm infant.Journal of perinatology : official journal of the California Perinatal Association · 2016Trial
- Dairy Bioactive Compounds as Precision Modulators of Gut Microbiota: From Molecular Mechanisms to Personalized Immunometabolic Health.Foods (Basel, Switzerland) · 2026Review
- Lactoferrin as a Non-Hormonal Therapeutic Candidate for Endometriosis: Mechanisms and Future Directions.Reproductive sciences (Thousand Oaks, Calif.) · 2026Review
- Processing-Induced Modifications of Camel Milk Immunoglobulins and Lactoferrin: Implications for Immunocompromised Pediatric Populations and Therapeutic Applications.Foods (Basel, Switzerland) · 2026Review
- Review
- Lactoferrin as a Candidate Multifunctional Therapeutic in Synucleinopathies.Brain sciences · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 3 institutions in 2 countries.
Funding
Abstract
backgroundLactoferrin (LF) is a broad-spectrum antimicrobial and immunomodulatory milk glycoprotein.
objectiveTo determine the effect of bovine LF on the prevention of the first episode of late-onset sepsis in Peruvian infants.
methodsWe 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.
resultsOne 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.
conclusionsOverall 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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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.