A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants.
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. 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 will start with a pilot phase in the Northern Region and Yorkshire Neonatal Networks. 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.
This diagram is a schematic representation of the ELFIN trial. It is divided into three stages: pre-intervention, intervention and post-intervention.
The pre-intervention stage is divided into 4 steps: pre-term infant, assess for eligibility, obtain parental consent and then randomisation.
The intervention stage shows the two possible treatments that an infant in the trial might receive: either lactoferrin, or a matched placebo. The treatment would start when the infant is receiving minimal milk feeds (at least 12 ml/kg/day) and would stop when the infant is 34 weeks' postmenstrual age.
The post-intervention stage shows that after lactoferrin or placebo treatment is completed, the infant is discharged from hospital. All clinical data collection takes place before the infant leaves hospital.
- EudraCT No.:
- REC Reference:
- Clinical Trials Unit:
- National Perinatal Epidemiology Unit CTU
- University of Oxford
- NIHR Health Technology Assessment (HTA) Programme
- Recruitment Target:
- 2,200 (including pilot phase)
- Duration of Study:
- March 2013 - December 2017
- Gestational age at birth is less than 32 weeks
- Infant is less than 72 hours old
- Written informed parental consent is obtained
- Infants with a severe congenital anomaly
- Anticipated enteral fasting of more than 14 days
- Infants who, in the opinion of the treating clinician, have no realistic prospect of survival
The primary outcome is the incidence of microbiologically-confirmed or clinically suspected late-onset invasive infection (defined as more than 72 hours after birth) from trial entry until hospital discharge.
- All-cause mortality prior to hospital discharge
- Necrotising enterocolitis: Bell’s stage II or III
- Severe retinopathy of prematurity treated medically or surgically
- Bronchopulmonary dysplasia: where the infant is still receiving mechanical ventilator support or supplemental oxygen at 36 weeks' postmenstrual age
- Total number of days of administration of antibiotic and antifungal agents
- A range of health economic outcomes
If you would like to contact the trial team, please email firstname.lastname@example.org.