ELFIN

• Research type

  Research Study

• Full title

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

• IRAS ID

  101849

• Contact name

  William McGuire

• Eudract number

  2012-004260-22

• ISRCTN Number

  N/A

• Research summary

  About 20% of very preterm (born before 32 weeks) infants acquire a serious infection in the neonatal unit. These infants are more likely to develop other problems including severe lung and bowel conditions, and have a higher risk of dying or being disabled. Better methods of preventing infection in very preterm infants are needed. This randomised 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. We will invite participation from 2,200 very preterm infants cared for in neonatal units across the UK (see www.npeu.ox.ac.uk/elfin for list). Parents will be offered information about the trial and will have 72 hours to consider whether to give their informed consent. Infants will be randomly allocated to receive either lactoferrin or placebo (sham treatment) mixed with their milk. Neither clinicians nor parents will be aware whether the infant receives lactoferrin or placebo - a 'double-blind' randomised controlled trial. 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 serious infection rates between the two groups, we will also assess the effect on the risk 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.The trial team includes clinicians whose daily work is caring for very preterm infants. In all of the neonatal units, staff are experienced in recruiting to similar trials and are aware of the needs and sensitivities of parents in the early newborn period. The trial is funded by a grant from the NIHR Health Technology Assessment programme.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  13/EM/0118

• Date of REC Opinion

  2 Apr 2013

• REC opinion

  Favourable Opinion