Condition category
Digestive System
Date applied
05/06/2013
Date assigned
13/06/2013
Last edited
07/05/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
About 20% of very preterm infants (born before 32 weeks) acquire a serious infection. 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 study will test whether giving them supplemental lactoferrin (a natural antibiotic protein from cow's milk) reduces the number of serious infections.

Who can participate?
We will invite participation from 2,200 very preterm infants (<32 weeks) cared for in neonatal units across the UK.

What does the study involve?
Parents will be offered information about the study and will have 72 hours to consider and give their informed consent. Infants will be randomly allocated to receive either lactoferrin or placebo (dummy) mixed with their milk. Neither doctors nor parents will be aware of what supplement the infants will receive. Treatment will continue until the infants are no longer at high risk of acquiring serious infections. As well as comparing serious infection rates between the two groups, we will also assess what effects this supplement has on the risk of other serious diseases and death, on the need for infants to receive multiple or prolonged courses of antibiotics and on the length of hospital stay.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part in the study. However, there should be benefits to future very preterm babies as the results of the study are likely to influence the NHS policy and practice.

Where is the study run from?
The study is run from the National Perinatal Epidemiology Unit Clinical Trials Unit, at the University of Oxford, UK.

When is the study starting and how long is it expected to run for?
Recruitment will start with six centres in the North of England, as part of a planned 9-month pilot, in September 2013. Following this, the study will be opened in further centres in England, Scotland and Northern Ireland and continue to recruit for a further three years.

Who is funding the study?
The National Institute for Health Research's Health Technology Assessment Programme (NIHR HTA)
has provided the funding for the study.

Who is the main contact?
Chief Investigator, Professor William McGuire: William.McGuire@hyms.ac.uk
Trial Co-ordinator, James Griffiths: james.griffiths@npeu.ox.ac.uk

Trial website

http://www.npeu.ox.ac.uk/elfin

Contact information

Type

Scientific

Primary contact

Prof William McGuire

ORCID ID

Contact details

Centre for Reviews and Dissemination
Hull York Medical School and University of York
York
YO10 5DD
United Kingdom
01904 321057
william.mcguire@hyms.ac.uk

Additional identifiers

EudraCT number

2012-004260-22

ClinicalTrials.gov number

Protocol/serial number

ELFIN01

Study information

Scientific title

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

Acronym

ELFIN

Study hypothesis

It is hypothesised that the proportion of very preterm (<32 weeks postmenstrual age) infants with at least one episode of late-onset invasive infection by the time of discharge from hospital will be lower in the lactoferrin group versus the placebo group

Ethics approval

National Research Ethics Service (NRES) Committee East Midlands - Nottingham 2, Ref: 13/EM/0118, Date: 02/04/2013

Study design

Phase III multi-centre placebo-controlled randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Preterm infants, necrotising enterocolitis, late-onset invasive infection, lactoferrin

Intervention

Infants will be randomly allocated to receive either lactoferrin (150 mg/kg/day to a maximum
of 300 mg) or placebo. Until discharge they will be monitored for late-onset invasive infection, necrotising enterocolitis, bronchopulmonary dysplasia, retinopathy of prematurity, length of hospital stay and length of time in intensive care.

Intervention type

Drug

Phase

Phase III

Drug names

Lactoferrin

Primary outcome measures

The incidence of microbiologically-confirmed or clinically suspected late-onset infection from
trial entry until hospital discharge. Clinicians will record whether or not infants have been treated for late-onset infection on the data collection form, however we are not recording specific test results.

Secondary outcome measures

1. All-cause mortality prior to hospital discharge
2. Necrotising enterocolitis (NEC): Bell's stage II or III
3. Severe retinopathy of prematurity (ROP) treated medically or surgically
4. Bronchopulmonary dysplasia (BPD): infant is still receiving mechanical ventilator support
or supplemental oxygen at 36 weeks' postmenstrual age
5. A composite of invasive infection, major morbidity (NEC, ROP, or BPD as defined above)
and mortality
6. Total number of days of administration of antibiotics per infant from 72 hours until death or discharge from hospital
7. Total number of days of administration of antifungal agents per infant
8. Total length of stay until discharge home
9. Length of stay in (i) intensive care, (ii) high dependency care, (iii) special care

Overall trial start date

01/03/2013

Overall trial end date

01/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Infants will be eligible to participate if:
1. Gestational age at birth is less than 32 weeks
2. Less than 72 hours old
3. Written informed parental consent is obtained

If infants are receiving antibiotic treatment for suspected or confirmed
Infection, they are still eligible for recruitment.

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

2200 (including pilot phase)

Participant exclusion criteria

1. Infants with severe congenital anomalies
2. Anticipated enteral fasting of more than 14 days
3. Infants who, in the opinion of the treating clinician, have no realistic prospect of survival

Recruitment start date

01/09/2013

Recruitment end date

01/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Hull York Medical School and University of York
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Clinical Trials and Research Governance
Joint Research Office
Block 60 Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) Health Technology Assessment Programme (HTA) (ref: 10/57/14)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes