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    Summary
    EudraCT Number:2022-003202-77
    Sponsor's Protocol Code Number:NEOKOFF22
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-02-03
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2022-003202-77
    A.3Full title of the trial
    The effect of additional pre-extubational loading dose of caffeine-citrate
    Pre-extubációs telítő dózisú koffein-citrát hatása az extubáció sikerességére
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of additional loading dose of caffeine-citrate prior ro extubation
    Telítő dózisú koffein-citrát hatása az a gépi lélegeztetésről történő leszoktatás sikerességére.
    A.3.2Name or abbreviated title of the trial where available
    NEOKOFF22
    NEOKOFF22
    A.4.1Sponsor's protocol code numberNEOKOFF22
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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 CITRATE DE CAFEINE COOPER
    D.2.1.1.2Name of the Marketing Authorisation holderCOOPERATION PHARMACEUTIQUE FRANÇAISE
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameCITRATE DE CAFEINE COOPER
    D.3.2Product code 34009 345 359 3 2
    D.3.4Pharmaceutical form Injection/infusion
    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 INNCaffeine citrate
    D.3.9.1CAS number 69-22-7
    D.3.9.3Other descriptive nameCaffeine citrate
    D.3.9.4EV Substance CodeSUB13151MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Extubation failure and bronchopulmonary dysplasia
    Az extubáció sikertelensége valamint a bronchopulmonáris dysplasia.
    E.1.1.1Medical condition in easily understood language
    The need for reintubation whithin the first 48 hours after extubation, and the development of BPD at the 36th weeks of postmenstrual age.
    A reintubáció szükségessége az extubációt követő első 48 órában, és a BPD kialakulása.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10002973
    E.1.2Term Apnea neonatal
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10071132
    E.1.2Term Primary apnea of premature newborns
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077322
    E.1.2Term Infantile apnea
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077325
    E.1.2Term Infantile obstructive apnea
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10077328
    E.1.2Term Infantile central apnea
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10028975
    E.1.2Term Neonatal respiratory failure
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10006475
    E.1.2Term Bronchopulmonary dysplasia
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076729
    E.1.2Term Very preterm infant
    E.1.2System Organ Class 100000004868
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level LLT
    E.1.2Classification code 10084217
    E.1.2Term Extremely preterm (less than 28 weeks)
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Our objective was to investigate wether an additional pre extubational loading dose of caffeine-citrate change the extubation success rate.
    Választ keresünk arra a kérdésre, hogy az extubáció előtti egyszeri telítő dózisú koffein-citrát alkalmazása hatással van-e az az extubáció sikerességére.
    E.2.2Secondary objectives of the trial
    In addition, we want to assess the frequency and severity of side effects. Our objectives include investigating the effect of caffeine-citrate on the development of BPD and IVH and PVL, as well as on the progression of IVH.
    Ezen túlmenően szeretnénk felmérni a mellékhatások gyakoriságát, és súlyosságát. Célkitűzéseink közé tartozik a koffein hatásának vizsgálata a BPD és IVH és PVL kialakulására, továbbá az IVH progressziójára.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Preterm neonates born before the 32nd week of gestation and had been mechanicaly ventillated for at least 48 hours. Before the first planned extubation.
    Betöltött 32. terhességi hét előtt született koraszülött.
    Első tervezett extubáció, legalább 48 óráig tartó folyamatos invazív lélegeztetés után.
    E.4Principal exclusion criteria
    Lack of consent.
    Preterm neonate with major congenital anomaly.
    Did not recieved surfactant therapy.
    Hydrops foetalis.
    Persistent tachycardia prior to extubation, foetal/neonatal arrhytmia.
    Asphyxia.
    Beleegyező nyilatkozat hiánya, vizsgálatban való részvétel megtagadása .
    Súlyos veleszületett fejlődési rendellenesség.
    Nem részesült felületaktív-anyag kezelésben.
    Hydrops foetalis.
    Perzisztens tachycardia extubáció előtt, magzati/neonatális arrhytmia.
    Asphyxia.
    E.5 End points
    E.5.1Primary end point(s)
    Reintubation
    Reintubáció
    E.5.1.1Timepoint(s) of evaluation of this end point
    First 48 hours after extubation.
    Az extubációt követő 48 óra.
    E.5.2Secondary end point(s)
    Frequency of apnoeas.
    Side effects (elevated heart rate, elevated blood pressure, gastric residuals)
    Necrotizing enterocolitis.
    Bronchopulmonary dysplasia.
    The progression or development of intraventricular hemorrhage or periventricular leukomalacia.
    Neurodevelopmental outcome.
    Apnoe gyakoriság.
    Mellékhatások monitorozása.
    Nekrotizáló enterocolitis.
    Bronchopulmonáris dysplasia kialakulása.
    Az intraventrikuláris vérzés vagy periventrikuláris leukomalácia kialakulása vagy progressziója.
    Fejlődésneurológiai kimenetel.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Frequency of apnoeas within the next 48 hours.
    Side effects: first 48 hours after extubation.
    Necrotizing enterocolitis: before discharge.
    Bronchopulmonary dysplasia: 36th week of postmenstrual age.
    The progression or development of intraventricular hemorrhage or periventricular leukomalacia: the last cranial ultrasound before discharge.
    Neurodevelopmental outcome at 2 years of age.
    Apnoe gyakoriság: az extubációt követő 48 óra.
    Mellékhatások monitorozása: az extubációt követő 48 óra.
    Nekrotizáló enterocolitis: elbocsájtás előtt.
    Bronchopulmonáris dysplasia kialakulása: a posztmenstruális 36. héten.
    Az intraventrikuláris vérzés vagy periventrikuláris leukomalácia kialakulása vagy progressziója: elbocsájtás előtti utolsó koponya ultrahang.
    Fejlődésneurológiai kimenetel két éves életkorban.
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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 Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.2.3.1Comparator description
    A koffein-citrát protokoll szerinti alkalmazása.
    Routine dosage of caffeine-cirate.
    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 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
    The discharge of the last patient.
    Az utolsó koraszülött elbocsájtása.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 226
    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: 226
    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
    Preterm newborns, born before the 32nd week of gestation, and had been mechanically ventillated for at least 48 hours.
    A 32. terhességi hét előtti koraszülöttek, akik legalább 48 órája gépi lélegeztetésben részesülnek.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state242
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 242
    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
    Nincs.
    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 Decision2023-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-16
    P. End of Trial
    P.End of Trial StatusOngoing
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