Trial reportJournal of perinatology : official journal of the California Perinatal Association2016
The Lacuna Trial: a double-blind randomized controlled pilot trial of lactoferrin supplementation in the very preterm infant.
Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 5 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
15 citing papers in PubMed, 5 syntheses or guidelines pooled it, 34 citations in OpenAlex.
- Protein supplementation of human milk for promoting growth in preterm infants.The Cochrane database of systematic reviews · 2020Pooled it
- Enteral lactoferrin supplementation for prevention of sepsis and necrotizing enterocolitis in preterm infants.The Cochrane database of systematic reviews · 2020Pooled it
- Pooled it
- Protein supplementation of human milk for promoting growth in preterm infants.The Cochrane database of systematic reviews · 2018Pooled 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
- Influence of bovine lactoferrin on feeding intolerance and intestinal permeability in preterm infants: a randomized controlled trial.European journal of pediatrics · 2024Trial
- Effect of Lactoferrin on Clinical Outcomes of Hospitalized Patients with COVID-19: The LAC Randomized Clinical Trial.Nutrients · 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
- Effects of Antioxidants in Human Milk on Bronchopulmonary Dysplasia Prevention and Treatment: A Review.Frontiers in nutrition · 2022Review
- Lactoferrin: Cytokine Modulation and Application in Clinical Practice.Journal of clinical medicine · 2021Review
- Is Mother's Own Milk Lactoferrin Intake Associated with Reduced Neonatal Sepsis, Necrotizing Enterocolitis, and Death?Neonatology · 2020Article
- 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
- 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
3 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo determine tolerability of bovine lactoferrin (bLF) in very preterm infants, and whether the intervention can be adequately masked. STUDY
designIn a single-center masked pilot trial infants under 31 weeks gestation were randomized before 48 h of age to receive milk with 100 mg per day of bLF or control. The primary outcome was feeding tolerance, defined as time to achieve full feeds (140 ml kg(-1) per day). Parents answered a short questionnaire regarding acceptability of the intervention.
resultsSeventy-nine infants were enrolled and analyzed according to intention to treat. There was no effect of bLF on the primary outcome. In addition, mortality, late onset sepsis and other complications of prematurity were no different. Equal numbers of parents in both groups believed their infant received bLF.
conclusionWe demonstrated that bLF is well tolerated, easy to administer and its presence in prepared milk is not evident. Trial registration number ISRCTN66482337.
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.