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    Summary
    EudraCT Number:2012-004260-22
    Sponsor's Protocol Code Number:ELFIN01
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-09-02
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2012-004260-22
    A.3Full title of the trial
    A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Will Lactoferrin supplements prevent infections in premature babies?
    A.3.2Name or abbreviated title of the trial where available
    ELFIN
    A.4.1Sponsor's protocol code numberELFIN01
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN88261002
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Oxford
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNational Institute of Health Research - Health Technology Assessment Programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNational Perinatal Epidemiology Unit
    B.5.2Functional name of contact pointUrsula Bowler
    B.5.3 Address:
    B.5.3.1Street AddressOld Road Campus
    B.5.3.2Town/ cityHeadington
    B.5.3.3Post codeOX3 7LF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01865289749
    B.5.5Fax number01865389701
    B.5.6E-mailursula.bowler@npeu.ox.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBovine Lactoferrin
    D.3.4Pharmaceutical form Powder and solvent for oral solution
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder and solvent for oral solution
    D.8.4Route of administration of the placeboEnteral use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Late onset invasive infection in very preterm infants
    E.1.1.1Medical condition in easily understood language
    Severe infections in very premature babies.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To test the efficacy of the enteral administration of 150 mg/kg/day of bovine lactoferrin in reducing 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 in a population of very preterm infants.
    E.2.2Secondary objectives of the trial
    To determine, in a population of very preterm infants, whether lactoferrin supplementation can reduce:

    • All-cause mortality prior to hospital discharge
    • Necrotising enterocolitis (NEC): Bell’s stage II or III
    • Severe Retinopathy of Prematurity (ROP) treated medically or surgically
    • Bronchopulmonary Dysplasia (BPD): infant is still receiving mechanical ventilator support or supplemental oxygen at 36 weeks’ postmenstrual age
    • A composite of invasive infection, major morbidity (NEC, ROP, or BPD as defined above) and mortality
    • Total number of days of administration of antibiotics per infant from
    72 hours until death or discharge from hospital
    • Total number of days of administration of antifungal agents per infant
    • Total length of stay until discharge home
    • Length of stay in (i) intensive care, (ii) high dependency care, (iii)
    special care
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Infants will be eligible to participate if:
    • Gestational age at birth is less than 32 weeks
    • Less than 72 hours old
    • Written informed parental consent is obtained

    If infants are receiving antibiotic treatment for suspected or confirmed infection, they are still eligible for recruitment.
    E.4Principal exclusion criteria
    • 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
    E.5 End points
    E.5.1Primary end point(s)
    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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From trial entry until discharge from hospital. (Typically at 36 to 42 weeks' postmenstrual age.)
    E.5.2Secondary end point(s)
    • All-cause mortality prior to hospital discharge
    • NEC: Bell’s stage II or III
    • Severe ROP treated medically or surgically
    • BPD: infant is still receiving mechanical ventilator support or
    supplemental oxygen at 36 weeks’ postmenstrual age
    • A composite of invasive infection, major morbidity (NEC, ROP, or BPD as defined above) and mortality
    • Total number of days of administration of antibiotics per infant from 72 hours until death or discharge from hospital
    • Total number of days of administration of antifungal agents per infant
    • Total length of stay until discharge home
    • Length of stay in (i) intensive care, (ii) high dependency care, (iii)
    special care
    E.5.2.1Timepoint(s) of evaluation of this end point
    From trial entry until discharge from hospital. (Typically at 36 to 42 weeks' postmenstrual age.)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 2200
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 2200
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Preterm infants
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state2200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2200
    F.4.2.2In the whole clinical trial 2200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The intervention is planned to cease when the participant reaches 34 weeks' post menstrual age. The participant will not have been discharged from hospital at that time, and will receive ongoing standard treatment.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-03
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