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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-000486-31
    Sponsor's Protocol Code Number:HD201
    National Competent Authority:Estonia - SAM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-05-19
    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 ConcernedEstonia - SAM
    A.2EudraCT number2015-000486-31
    A.3Full title of the trial
    The effect of milrinone on central and regional blood flow in preterm neonates undergoing patent ductus arteriosus ligation.
    Milrinooni toime tsentraalsele ja regionaalsele verevoolule enneaegsetel vastsündinutel peale avatud arterioosjuha ligeerimist.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of milrinone in preterm neonates after open arterial duct operation.
    Milrinooni toime enneaegsetel vastsündinutel peale avatud arterioosjuha operatsiooni.
    A.4.1Sponsor's protocol code numberHD201
    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 SponsorDepartment of Anaesthesiology and Intensive Care, University of Tartu
    B.1.3.4CountryEstonia
    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 supportUniversity of Tartu
    B.4.2CountryEstonia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Tartu
    B.5.2Functional name of contact pointDepartment of Anaesthesiology
    B.5.3 Address:
    B.5.3.1Street AddressL.Puusepa 8-G1,209
    B.5.3.2Town/ cityTartu
    B.5.3.4CountryEstonia
    B.5.6E-mailmaarja.hallik@ut.ee
    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 Primacor, Corotrope
    D.2.1.1.2Name of the Marketing Authorisation holderAventis Pharma Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMILRINONE
    D.3.9.1CAS number 78415-72-2
    D.3.9.4EV Substance CodeSUB08968MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Acute cardiorespiratory deterioration in preterm neonates 6-12 hours after open arterial duct ligation that is called post ligation cardiac syndrome (PLCS).
    Kardio-respiratoorse seisundi halvenemine enneaegsetel vastsündinutel 6-12 tundi peale avatud arterioosjuha ligeerimist mida nimetatakse post ligation cardiac syndrome (PLCS).
    E.1.1.1Medical condition in easily understood language
    Deterioration of heart and lung function in preterm neonates 6-12 hours after open arterial duct operation.
    Südame-vereringesüsteemi ja hingamissüsteemi seisundi halvenemine enneaegsetel vastsündinutel 6-12 tundi peale avatud arterioosjuha operatsiooni.
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    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 describe the pharmacokinetics and pharmacodynamics of milrinone in premature neonates after patent arterial duct surgical ligation.
    Kirjeldada milrinooni farmakokineetikat ja farmakodünaamikat enneaegsetel vastsündinutel peale avatud arterioosjuha kirurgilist sulgemist.
    E.2.2Secondary objectives of the trial
    To assess the safety profile of milrinone in preterm neonates, treated for post ligation cardiac syndrome.
    Hinnata milrinooni ohutust enneaegsetel vastsündinutel, keda ravitakse peale arterioosjuha ligeerimist tekkiva südamepuudulikkuse tõttu.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Neonates and infants up to 90 days of age
    2) Haemodynamically significant PDA requiring surgical ligation
    3) Arterial catheter and/or central venous catheter in place on clinical indication
    4) Informed consent given by the parents or guardians
    1) Vastsündinud ja imikud kuni 90 päeva vanuseni
    2) Hemodünaamiliselt oluline avatud arterioosjuha, mille kirurgiline sulgemine on näidustatud
    3) Arteri- ja/või tsentraalvenoosse kanüül on paigaldatud kliinilistel näidustustel
    4) Vanemate või seadusliku esindaja kirjalik teavitatud nõusolek uuringus osalemiseks
    E.4Principal exclusion criteria
    1) Renal failure requiring renal replacement therapy (peritoneal dialysis) or serum creatinine >100 μmol/l or oliguria <0.5 ml/kg/min within 6 hours
    2) Hypersensitivity to milrinone or any other component of the study drug
    3) Situation where the treating physician considers milrinone to be contraindicated
    4) Major congenital malformation
    5) Known metabolic disease
    6) Informed consent from parents or guardians not obtained
    7) Critically unstable state of the patient, likely fatal within 72 hours
    8) The patient is already recruited in another clinical trial investigating a medical product
    1) Neerupuudulikkus: neeruasendusravi (peritoneaaldialüüsi) vajadus või seerumi kreatiniin >100 μmol/l või oliguuria <0.5 ml/kg/min kuue tunni jooksul
    2) Ülitundlikkus milrinooni või mõne muu uuringuravimis sisalduva komponendi suhtes
    3) Olukord, kui raviarsti arvates on milrinooni manustamine vastunäidustatud
    4) Kaasasündinud väärareng, mis oluliselt mõjutab oodatava eluea pikkust
    5) Teadaolev ainevahetushaigus
    6) Puudub vanemate või seadusliku esindaja teavitatud nõusolek uuringus osalemiseks
    7) Üliraske seisund, mis suure tõenäosusega viib surmlõppele 72 tunni jooksul
    8) Osalemine teises ravimuuringus
    E.5 End points
    E.5.1Primary end point(s)
    The pharmacokinetics of milrinone in neonates and infants up to 90 days of age, treated for post ligation cardiac syndrome..

    Adverse events experienced by neonates receiving milrinone.
    Milrinooni farmakokineetika vastsündinutel ja imikutel kuni 90 päeva vanuseni, keda ravitakse peale arterioosjuha ligeerimist tekkiva südamepuudulikkuse tõttu.

    Milrinooni ebasoodsad toimed vastsündinutel.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Pharmacokinetic parameters are evaluated during the 24 hour treatment period and 12 hours after the end of treatment with IMP.

    Adverse events are recorded until 7 days after the end of treatment with IMP.
    Milrinooni farmakokineetikat hinnatakse 24 tunnise raviperioodi jooksul ja 12 tundi peale ravi lõpetamist milrinooniga.

    Ebasoodsaid toimeid registreeritakse kuni 7 päeva peale ravi lõpetamist.
    E.5.2Secondary end point(s)
    Pharmacodynamics of milrinone, including effects on blood pressure, heart rate and percutaneous oxygen saturation; central haemodynamics (LVO, RVO, ejection fraction, myocardial shortening fraction and tissue Doppler velocities) assessed by heart ultrasonography, regional cerebral perfusion (rScO2, cFTOE), assessed by NIRS and microcirculation, assessed by SDF imaging in neonates undergoing PDA ligation with and without milrinone treatment.

    Clinical and biochemical measures of systemic hypoperfusion, including blood gases, lactate; diuresis.

    Clinical outcome at FU visit – survival, duration of respiratory and vasoactive support.

    Neurological evaluation as assessed by cerebral ultrasound (and if persistently abnormal, by MRI or CT) at any time up until the FU visit;
    Milrinooni faramakodünaamika: toime vererõhule, südamesagedusele, hapnikusaturatsioonile, tsentraalse hemodünaamika parameetritele (hinnatakse südame ultraheliuuringul), aju regionaalsele verevoolule(hinnatakse NIRS monitooringuga) ja naha mikrotsirkulatsioonile (hinnatakse videokapillaroskoopial).

    Süsteemse hüpoperfusiooni kliinilised ja biokeemilised tunnused - veregaasid, laktaat, diurees.

    Kliiniline tulem FU visiidil - elulemus, hingamis- ja vereringetoetuse kestus.

    Neuroloogiline hindamine aju ultraheliuuringul, vajadusel CT või MRT uuringul FU visiidil.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The pharmacodynamic effect of milrinone is evaluated during 24 hour treatment period, haemodynamic parameters are recorded continuously or 3 and 24 hours after the start of treatment (heart ultrasonography and videocapillaroscopy).

    Clinical and biochemical measures of hypoperfusion are taken every 6 hours during the treatment period.

    FU visit is 7 days after the end of treatment with IMP.
    Milrinooni farmakodünaamilist toimet hinnatakse 24 tunnise raviperioodi jooksul, hemodünaamika parameetrid salvestatakse pidevalt või 3 ja 24 tundi peale ravi alustamist (südame ultraheliuuring ja videokapillaroskoopia).

    Hüpoperfusiooni kliinilisi ja biokeemilisi tunnuseid hinnatakse ravi ajal iga 6 tunni järel.

    FU visiit on 7 päeva peale ravi lõpetamist milrinooniga.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    E.7.1.3.1Other trial type description
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned2
    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 No
    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 years2
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    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: 30
    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: 30
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 5
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 5
    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 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
    Neonates and infants.
    Vastsündinud ja imikud.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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)
    None.
    Ei Ole.
    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 Decision2015-05-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
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