Related Experiment Video
Updated: Dec 11, 2025
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
ELFIN, the United Kingdom preterm lactoferrin trial: interpretation and future questions 1
Janet Elizabeth Berrington1, William McGuire2, Nicholas David Embleton3
1Newcastle Upon Tyne Hospitals NHS Foundation Trust, and Translational and Clinical Medicine, Newcastle University, Newcastle, UK.
Insights
Supplemental bovine lactoferrin (BLF) did not reduce late-onset sepsis (LOS) or necrotising enterocolitis (NEC) in preterm infants. The Enteral Lactoferrin in Neonates (ELFIN) trial found no significant benefit, differing from some previous studies.
Area of Science:
- Neonatal medicine
- Clinical trials
- Gastroenterology
Background:
- Previous studies suggested bovine lactoferrin (BLF) supplementation reduced late-onset sepsis (LOS) and necrotising enterocolitis (NEC) in preterm infants.
- The Enteral Lactoferrin in Neonates (ELFIN) study was a large, UK-based trial to confirm these potential benefits.
Purpose of the Study:
- To determine if BLF supplementation reduces LOS and NEC in preterm infants.
- To evaluate other clinical outcomes associated with BLF in this population.
Main Methods:
- A well-powered, double-blind, placebo-controlled trial involving over 2200 preterm infants (<32 weeks gestation).
- Infants received either BLF or a placebo, and outcomes including LOS and NEC were monitored.
Main Results:
- The ELFIN study did not demonstrate a significant reduction in LOS (316/1093 vs. 334/1089, RR 0.95 [0.86–1.04]) or NEC.
- No significant differences were observed in other key clinical measures between the BLF and placebo groups.
Conclusions:
- BLF supplementation did not reduce the incidence of LOS or NEC in the studied preterm infant population.
- Discrepancies with prior research may be due to population differences, antifungal prophylaxis use, or variations in lactoferrin properties or administration timing.
Abstract:
Results from previous studies have suggested that supplemental bovine lactoferrin (BLF) given to preterm infants (<32 weeks gestation) reduces late-onset sepsis (LOS) and necrotising enterocolitis (NEC). The Enteral Lactoferrin in Neonates (ELFIN) study, performed in the UK, aimed to further address this issue with a well powered double-blind placebo controlled trial of >2200 preterm infants. The results from ELFIN did not demonstrate a reduction in LOS or NEC, or several other clinically important measures. Of the 1093 infants, 316 (29%) in the intervention group developed late-onset sepsis versus 334 (31%) of 1089 in the control group, with an adjusted risk ratio of 0.95 (95% CI = 0.86-1.04; p = 0.233). Reasons for the differences in ELFIN trial results and other studies may include population differences, the routine use of antifungal prophylaxis in the UK, timing of administration of the lactoferrin in relation to disease onset, or specific properties of the lactoferrin used in the different trials. The UK National Institutes for Health Research funded "Mechanisms Affecting the Guts of Preterm Infants in Enteral feeding trials" (MAGPIE) study is further exploring the use of lactoferrin, and the results should be available soon.
More Related Videos
08:50A Murine Model of Fetal Exposure to Maternal Inflammation to Study the Effects of Acute Chorioamnionitis on Newborn Intestinal Development
Published on: June 24, 2020
10:17Analysis of Fucosylated Human Milk Trisaccharides in Biotechnological Context Using Genetically Encoded Biosensors
Published on: April 13, 2019