Trial reportThe Journal of pediatrics2020
Randomized Controlled Trial of Bovine Lactoferrin for Prevention of Sepsis and Neurodevelopment Impairment in Infants Weighing Less Than 2000 Grams.
Trial report in The Journal of pediatrics, 2020. 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 25 papers, 1 of them a synthesis 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
25 citing papers in PubMed, 1 synthesis or guideline pooled it, 53 citations in OpenAlex.
- Enteral lactoferrin supplementation for prevention of sepsis and necrotizing enterocolitis in preterm infants.The Cochrane database of systematic reviews · 2020Pooled it
- Infant formula iron fortification of 2 vs. 8 mg/L does not increase the risk of iron deficiency or impact neurodevelopment at 12 months.Journal of pediatric gastroenterology and nutrition · 2026Trial
- Preventing Sepsis in Preterm Infants with Bovine Lactoferrin: A Randomized Trial Exploring Immune and Antioxidant Effects.Nutrients · 2025Trial
- Do preterm infants' retinas like bovine colostrum? A randomized controlled trial.Italian journal of pediatrics · 2024Trial
- Effect of Lactoferrin on Clinical Outcomes of Hospitalized Patients with COVID-19: The LAC Randomized Clinical Trial.Nutrients · 2023Trial
- Human milk oligosaccharides and their association with late-onset neonatal sepsis in Peruvian very-low-birth-weight infants.The American journal of clinical nutrition · 2020Trial
- Associations of human milk lactoferrin with measures of physical growth in very preterm infants.Journal of perinatology : official journal of the California Perinatal Association · 2026Article
- Review
- Lactoferrin as a Candidate Multifunctional Therapeutic in Synucleinopathies.Brain sciences · 2025Review
- Lactoferrin as a Versatile Agent in Nanoparticle Applications: From Therapeutics to Agriculture.Nanomaterials (Basel, Switzerland) · 2024Review
- Innovative Strategies and Methodologies in Antimicrobial Peptide Design.Journal of functional biomaterials · 2024Review
- Invasive Candida Infections in Neonatal Intensive Care Units: Risk Factors and New Insights in Prevention.Pathogens (Basel, Switzerland) · 2024Review
- Lactoferrin intake from maternal milk during the neonatal hospitalization and early brain development among preterm infants.Pediatric research · 2024Article
- Neonatal Necrotizing Enterocolitis: An Update on Pathophysiology, Treatment, and Prevention.Paediatric drugs · 2024Review
- Comparison of Non-Covalent and Covalent Interactions between Lactoferrin and Chlorogenic Acid.Foods (Basel, Switzerland) · 2024Article
- Key biologically active components of breast milk and their beneficial effects.Seminars in pediatric surgery · 2023Review
- Evidence for human milk as a biological system and recommendations for study design-a report from "Breastmilk Ecology: Genesis of Infant Nutrition (BEGIN)" Working Group 4.The American journal of clinical nutrition · 2023Article
- The role of human milk nutrients in preventing necrotizing enterocolitis.Frontiers in pediatrics · 2023Review
- Human milk oligosaccharides as immunonutrition key in early life.Clinical and experimental pediatrics · 2022Article
- Nutritional Supplements to Improve Outcomes in Preterm Neonates.Clinics in perinatology · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 3 institutions in 2 countries.
Funding
Abstract
objectivesTo determine the effect of bovine lactoferrin on prevention of late-onset sepsis (LOS) and neurodevelopment delay. STUDY
designRandomized, double-blind, controlled trial in neonates with a birth weight of 500-2000 g in 3 neonatal units in Lima, Peru, comparing bovine lactoferrin 200 mg/kg/day with placebo administered for 8 weeks. The primary outcome was the first episode of culture-proven LOS or sepsis-associated death. Neurodevelopment delay was assessed by the Mullen Scales at 24 months corrected age.
resultsOf the 414 infants enrolled, 209 received bovine lactoferrin and 205 received placebo. LOS or sepsis-associated death occurred in 22 infants (10.5%) in the bovine lactoferrin group vs 30 (14.6%) in the placebo group; there was no difference after adjusting for hospital and birth weight; hazard ratio 0.73 (95% CI, 0.42-1.26). For infants with birth weights of <1500 g the hazard ratio was 0.69 (95% CI, 0.39-1.25). The mean age-adjusted normalized Mullen composite score at 24 months was 83.3 ± 13.6 in the bovine lactoferrin group vs 82.6 ± 13.1 in the placebo group. Growth outcomes and rehospitalization rates during the 2-year follow-up were similar in both groups, except for significantly less bronchiolitis in the bovine lactoferrin group (rate ratio, 0.34; 95% CI, 0.14-0.86).
conclusionsSupplementation with bovine lactoferrin did not decrease the incidence of sepsis in infants with birth weights of <2000 g. Growth and neurodevelopment outcomes at 24 months of age were similar. Neonatal bovine lactoferrin supplementation had no adverse effects.
trial registrationClinicalTrials.gov: NCT01525316.
Indexed as
Identifiers
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.