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    Summary
    EudraCT Number:2008-000046-31
    Sponsor's Protocol Code Number:Omega18-13-03
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-04-11
    Trial 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 ConcernedSweden - MPA
    A.2EudraCT number2008-000046-31
    A.3Full title of the trial
    A randomised Intervention, Single-Center Study to Determine the Role of Fatty Acids in Serum in preventing
    Retinopathy of Prematurity
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can supplementation with Omega-3 fatty acids in preterm infants improve visual and cognitive outcome?
    Kan Omega-3 fettsyror förbättra syn och utveckling hos för tidigt födda barn?
    A.4.1Sponsor's protocol code numberOmega18-13-03
    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 SponsorThe Sahlgrenska Center for Pediatric Ophtalmology Research
    B.1.3.4CountrySweden
    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 supportThe Sahlgrenska Center for Pediatric Ophtalmology Research
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Pediatrics Institute of Clinical Science
    B.5.2Functional name of contact pointwww.rop.gu.se/clinical trials
    B.5.3 Address:
    B.5.3.1Street AddressThe Queen Silvia Children´s Hospital
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code41685
    B.5.3.4CountrySweden
    B.5.4Telephone number+46768979196
    B.5.5Fax number+4631848952
    B.5.6E-mailann.hellstrom@medfak.gu.se
    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 Yes
    D.2.1.1.1Trade name SMOFlipid 200 mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderFresenius Kabi AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameSMOFlipid 200 mg/ml
    D.3.4Pharmaceutical form Emulsion for infusion
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntravenous use
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Clinoleic 200mg/ml/B05BA02/Emulsion for Infusion
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameClinoleic 200mg/ml
    D.3.2Product code KDB9500
    D.3.4Pharmaceutical form Emulsion for infusion
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntravenous use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Premature male/female infants, <28 gestational weeks at birth with risk of developing retinopathy of prematurity (ROP)
    Retinopathy of Prematurity
    E.1.1.1Medical condition in easily understood language
    Blinding disease in preterm infants
    Synhotande sjukdom hos prematurfödda barn
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1) To determine how fatty acid (FA) levels in premature infants (born with a gestational age < 28 weeks) are affected by supplementation of “physiologic levels of long chain polyunsaturated fatty acids (LCPUFA) i.e. Omega-3 and 6.

    2) To determine whether these FA levels protect against development of retinopathy of prematurity (ROP).

    E.2.2Secondary objectives of the trial
    Secondary objective

    1) To determine whether these FA levels normalize growth (length, weight, head circumference) and/or

    2) To determine whether these FA levels reduce the risk of lung, brain and gut morbidity
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all the following inclusion criteria to be permitted into this study:
    1. Signed informed consent from parents/guardians;
    2. Subject must be <28 weeks of gestation
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will be excluded from the study:
    1. Detectable clinical gross malformation;
    2. Known or suspected chromosomal abnormality, genetic disorder, or syn-drome, according to the investigator’s opinion;

    3. Clinically significant neuropathy, nephropathy, retinopathy, or other micro- or macrovascular disease requiring treatment, according to the investigator’s opinion;
    4. Any other condition or therapy that, in the investigator’s opinion, may pose a risk to the subject or interfere with the subject’s ability to be compliant with this protocol or interfere with interpretation of results;
    5. Bleeding disorder.
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy Endpoints: To compare in supplemented versus conventionally treated children

    A) Bloodsamples from the child will be taken according to present clinical practice and if possible from cord (2ml) and at days 0, 7, 14, 28 and in postmenstrual weeks 32, 36 and 40. Breast milk samples will be taken day 7 and at PMA of 32 and 40 weeks.
    B) Development of ROP

    Safety Endpoints: Adverse events, clinical chemistry, retinal exam, physical ex-amination, vital signs.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ROP examination
    Retinal examination will be performed once weekly starting at five to six weeks of age according to a standardized protocol and to clinical screening praxis. The ophthalmologic assessment will be performed with strict criteria according to general Swedish Guidelines issued by the Swedish Ophthalmological Society: The Guidelines are available at following link: www.swedeye.org/SOTA/rop/SOTA-ROP_2006.pdf.

    E.5.2Secondary end point(s)
    A) SDS score with regard to length, weight and head circumference growth
    B) Bronchopulmonary dysplasia, brain development on MRI examination and necrotizing enterocolitis

    E.5.2.1Timepoint(s) of evaluation of this end point
    Growth
    Length, weight and head circumference will be registered weekly from birth until 40 weeks postmenstrual age and at 2.5 and 6 years.


    Neurologic development
    Cranial ultrasound will be performed according to clinical praxis. MRI of the brain will be performed at 40 weeks PMA.

    At 2.5 years a clinical examination including neurologic evaluation (neurologist) cognitive evaluation with Bailey-test (psychologist) and ophthalmologic examination will be performed.

    At 6 years a clinical examination including neurologic evaluation (neurologist) cognitive evaluation with WPPSI alt WISC, short visuo-motor test and a behavioral test and extensive ophthalmologic examination, including visual perception and morpho-logic and functional examination of the retina, will be performed.
    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 Yes
    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 No
    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 Yes
    E.7.1.3.1Other trial type description
    Prophylaxis
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    SMOFlipid
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    End of the trial is when the last patient has performed 6 years follow up for growth and visual as well as cognitive development
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 90
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 90
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 Yes
    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
    Infants, informed consent will be obtained from parents.
    Barnsamtycke kommer att inhämtas av föräldrar.
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    premature infants 23-28 gestational weeks at birth
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    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)
    Treatment will continue according to normal treatment routines
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
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