Trial reportThe Journal of pediatrics2016
Randomized Controlled Trial of Talactoferrin Oral Solution in Preterm Infants.
Trial report in The Journal of pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00854633 (Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants), which is not on this map. Cited by 24 papers, 4 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.
Phase 1/2 Study of Talactoferrin Oral Solution for Nosocomial Infection in Preterm Infants
Who cites it
24 citing papers in PubMed, 4 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Enteral lactoferrin supplementation for prevention of sepsis and necrotizing enterocolitis in preterm infants.The Cochrane database of systematic reviews · 2020Pooled it
- Nutritional interventions to reduce rates of infection, necrotizing enterocolitis and mortality in very preterm infants.Pediatric research · 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
- Preventing Sepsis in Preterm Infants with Bovine Lactoferrin: A Randomized Trial Exploring Immune and Antioxidant Effects.Nutrients · 2025Trial
- A randomized controlled trial of oropharyngeal therapy with mother's own milk for premature infants.Journal of perinatology : official journal of the California Perinatal Association · 2023Trial
- 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
- Lactoferrin concentration in breast milk of mothers of low-birth-weight newborns.Journal of perinatology : official journal of the California Perinatal Association · 2017Trial
- 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
- Emerging antimicrobial therapies for Gram-negative infections in human clinical use.npj antimicrobials and resistance · 2025Review
- Milk Bioactive Compounds and Gut Microbiota Modulation: The Role of Whey Proteins and Milk Oligosaccharides.Foods (Basel, Switzerland) · 2024Review
- Nanoparticular and other carriers to deliver lactoferrin for antimicrobial, antibiofilm and bone-regenerating effects: a review.Biometals : an international journal on the role of metal ions in biology, biochemistry, and medicine · 2023Review
- The potential for Lactoferrin to reduce SARS-CoV-2 induced cytokine storm.International immunopharmacology · 2021Review
- A Human Milk-Based Protein Concentrate Developed for Preterm Infants Retains Bioactive Proteins and Supports Growth of Weanling Rats.The Journal of nutrition · 2021Article
- Breast Milk: A Source of Functional Compounds with Potential Application in Nutrition and Therapy.Nutrients · 2021Review
- Enteral Lactoferrin Supplementation for Preventing Sepsis and Necrotizing Enterocolitis in Preterm Infants: A Meta‑Analysis With Trial Sequential Analysis of Randomized Controlled Trials.Frontiers in pharmacology · 2020Review
- Is Mother's Own Milk Lactoferrin Intake Associated with Reduced Neonatal Sepsis, Necrotizing Enterocolitis, and Death?Neonatology · 2020Article
- Review shows that donor milk does not promote the growth and development of preterm infants as well as maternal milk.Acta paediatrica (Oslo, Norway : 1992) · 2019Review
- Lactoferrin: A Critical Player in Neonatal Host Defense.Nutrients · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 4 institutions in 1 country.
Funding
Abstract
objectiveTo evaluate the safety and explore the efficacy of recombinant human lactoferrin (talactoferrin [TLf]) to reduce infection. STUDY
designWe conducted a randomized, double blind, placebo-controlled trial in infants with birth weight of 750-1500 g. Infants received enteral TLf (n = 60) or placebo (n = 60) on days 1 through 28 of life; the TLf dose was 150 mg/kg every 12 hours. Primary outcomes were bacteremia, pneumonia, urinary tract infection, meningitis, and necrotizing enterocolitis (NEC). Secondary outcomes were sepsis syndrome and suspected NEC. We recorded clinical, laboratory, and radiologic findings, along with diseases and adverse events, in a database used for statistical analyses.
resultsDemographic data were similar in the 2 groups of infants. We attributed no enteral or organ-specific adverse events to TLf. There were 2 deaths in the TLf group (1 each due to posterior fossa hemorrhage and postdischarge sudden infant death), and 1 death in the placebo group, due to NEC. The rate of hospital-acquired infections was 50% lower in the TLf group compared with the placebo group (P < .04), including fewer blood or line infections, urinary tract infections, and pneumonia. Fourteen infants in the TLf group weighing <1 kg at birth had no gram-negative infections, compared with only 3 of 14 such infants in the placebo group. Noninfectious outcomes were not statistically significantly different between the 2 groups, and there were no between-group differences in growth or neurodevelopment over a 1-year posthospitalization period.
conclusionWe found no clinical or laboratory toxicity and a trend toward less infectious morbidity in the infants treated with TLf.
trial registrationClinicalTrials.gov: NCT00854633.
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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.