Enteral LactoFerrin In Neonates
| ISRCTN | ISRCTN88261002 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN88261002 |
| EudraCT/CTIS number | 2012-004260-22 |
| Secondary identifying numbers | ELFIN01 |
- Submission date
- 05/06/2013
- Registration date
- 13/06/2013
- Last edited
- 14/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
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
Contact information
Scientific
Centre for Reviews and Dissemination
Hull York Medical School and University of York
York
YO10 5DD
United Kingdom
| Phone | 01904 321057 |
|---|---|
| william.mcguire@hyms.ac.uk |
Study information
| Study design | Phase III multi-centre placebo-controlled randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants |
| Study acronym | ELFIN |
| Study objectives | 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(s) | National Research Ethics Service (NRES) Committee East Midlands - Nottingham 2, Ref: 13/EM/0118, Date: 02/04/2013 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Lactoferrin |
| Primary outcome measure | 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 study start date | 01/03/2013 |
| Completion date | 31/05/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 2200 (including pilot phase) |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/09/2013 |
| Date of final enrolment | 28/09/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
YO10 5DD
United Kingdom
Sponsor information
University/education
Clinical Trials and Research Governance
Joint Research Office
Block 60 Churchill Hospital
Old Road, Headington
Oxford
OX3 7LE
England
United Kingdom
"ROR" |
https://ror.org/052gg0110 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2018 | Yes | No | |
| Results article | results | 02/02/2019 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
14/01/2019: Publication reference added.
02/01/2019: Publication reference added.
22/01/2018: Recruitment end date was changed from 01/12/2017 to 28/09/2017. The overall trial end date was changed from 01/12/2017 to 31/05/2018.
