ELFIN trial - a multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants

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Principal investigator: William McGuire (University of York)
Collaborators: Gerry Richardson (University of York), Sam Oddie (Bradford Teaching Hospitals NHS Foundation Trust), Paul Heath (St George's Hospital, London), Nicholas Embleton (Royal Victoria Infirmary, Newcastle), Jon Dorling (Nottingham University Hospitals NHS Trust, Nottingham, UK), Janet Berrington (Royal Victoria Infirmary, Newcastle), Jane Abbott (Bliss (PPI), London), Ed Juszczak (NPEU), Louise Linsell (NPEU)
Topics: Care of the preterm or low birthweight infant, Preterm birth
Funder: National Institute for Health Research Health Technology Assessment Programme
Start year: 2013
End year: 2017

Summary

This multi-centre randomised placebo-controlled trial will evaluate whether giving very preterm infants supplemental lactoferrin (a natural antibiotic protein from cow's milk) reduces the number of serious infections. About 20% of very preterm infants (born before 32 weeks of gestation) acquire a serious infection in the neonatal unit. Better methods of preventing infection in very preterm infants are needed.

ELFIN started with an internal pilot phase in 5 centres in the Northern Region and Yorkshire Neonatal Networks. Feasibility was shown during this initial pilot phase in 6 months. A total of 2,200 infants will now be recruited to participate in the trial over a four year period.

The main trial will invite participation from very preterm infants cared for in neonatal units across the UK. Treatment will continue until the infants are no longer at high risk of acquiring serious infections (34 weeks postmenstrual age; a maximum of 70 days treatment will be given). As well as comparing the incidence of serious infection between the two groups, we will also assess the effect on the incidence of other serious diseases and death, on the need for infants to receive multiple or prolonged courses of antibiotics (a major cause of antibiotic resistance in neonatal units), and on the length of hospital stay.

Publications

Journal Articles

Griffiths J, Jenkins P, Vargova M, Bowler U, Juszczak E, King A, Linsell L, Murray D, Partlett C, Patel M, Berrington J, Dorling J, Embleton ND, Heath PT, Oddie S, McGuire W, Ainsworth S, Boyle E, Clarke P, Craig S, Johnson K, Mactier H, Scorrer T, Ledwidge M, Story I, Holder G, Ohadike P, Ellis S, Vaikute R, Gowda G, Yates H, Garg S, Pilling E, Roehr C, Batra D, Gibson D, Johnson M, Kumar Y, Bartle D, Peters C, Quine D, Gupta R, Matthes J, Kennea N, Reynolds P, Geethanath R, Janakiraman S, Vasu V, Manjunatha CM. Enteral lactoferrin supplementation for very preterm infants: a randomised placebo-controlled trial. The Lancet. 2019;393(10170):423-33.