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    The EU Clinical Trials Register currently displays   36859   clinical trials with a EudraCT protocol, of which   6085   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2013-005572-17
    Sponsor's Protocol Code Number:20132312
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-03-19
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-005572-17
    A.3Full title of the trial
    Optimizing propofol dosing for (preterm) newborn infants that need
    endotracheal intubation
    Optimaliseren van de dosis propofol voor sedatie bij endotracheale intubatie van (premature) neonaten
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to optimise the dose of the anesthetic agent propofol that
    is given to newborn babies to make them asleep before a tube is putted in
    their airway to start artificial ventilation. Propofol dose is optimised for
    newborns of different ages.
    Studie op de dosering van propofol (een slaapmiddel) de optimaliseren die nodig is bij pasgeborenen om ze te laten slapen tijdens het inbrangen van een beademingsbuisje
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number20132312
    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 SponsorErasmus Medical Center
    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 supportZonMW
    B.4.1Name of organisation providing supportfindsNutsOhra
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC Sophia Children's hospital
    B.5.2Functional name of contact pointStudie coordinator
    B.5.3 Address:
    B.5.3.1Street AddressWytemaweg 80
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CN
    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. name propofol
    D. of the Marketing Authorisation holdercollege ter beoordeling van geneesmiddelen
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namepropofol
    D.3.2Product code N01A X10
    D.3.4Pharmaceutical form Concentrate and solvent for solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Sedation for endotracheal intubation in newborns of different ages at the
    neonatal intensive care unit
    Sedatie voor endotracheale intubatie bij pasgeborenen van verschillende leeftijden op de neonatale intensive care
    E.1.1.1Medical condition in easily understood language
    Critically ill newborn babies that need to artificial ventilation are
    evaluated during the procedure where the tube for ventilation is
    Ernstig zieke pasgeborenen die een beademingsbuisje nodig hebben op de intensive care
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10029392
    E.1.2Term Newborn
    E.1.2System Organ Class 100000004869
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the most adequate age specific propofol doses for
    neonates of different ages (both gestational age and postnatal age).
    Adequate propofol doses are determined by 3 co-primary outcome
    - Adequate sedation
    - Optimal intubation conditions
    - No hypotension or other severe side effects
    Het vaststellen van de meest adequate leeftijdspecifiekepropofol doseringen voor pasgeborenen
    De adequate dosis zal worden bepaald afhankelijk van:
    - goede sedatie
    -goede intubatieconditie
    - geen hypotensie of andere ernstige bijwerkingen
    E.2.2Secondary objectives of the trial
    - To develop a validated and useful sedation assessment instrument for
    (preterm) newborns during endotracheal intubation. For this aim
    validated pain assessment instruments will be compared with an
    available sedation score by the use of videotapes. Furthermore we
    aim to determine the relationship between these pain and sedation
    scores with the patients stress level as measured by cortisol levels.
    - To determine a new age specific PK/PD
    (pharmacokinetic/pharmacodynamic) model for propofol.
    Pharmacodynamic data of propofol are explored (duration of intubation,
    duration of sedation, time of side effect, recovery of spontaneous
    breathing). We will analyze propofol concentrations in a
    - een gevalideerde en bruikbare sedatieschaal bepalen
    - een leeftijdsafhankeleijk PK/PD model voor propofol
    - exploratie van het propofol genotype
    - exploratie van de hemodynamische effecten van propofol
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All neonates admitted to the participating intensive care units:
    - Less than 28 days postnatal age
    - Who need endotracheal intubation
    Alle pasgeborenen opgenomen op de deelnemende neonatale intensive care afdelingen dei
    minder dan 28 dagen oud zijn en
    die een endotracheale intubatie moeten ondergaan
    E.4Principal exclusion criteria
    Patients with:
    - Major congenital anomalies or neurological disorders,
    - Neonates with an abnormal upper airway,
    - Those receiving continuous sedatives or opioids, and
    - Those whose mothers received sedatives or opioids before or during
    delivery will be excluded during the first 2 days of life
    - Those who previously participated in the study
    - Pasgeborenen met afwijkende bovenste luchtwegen,
    - die continue sedativa of opiaten krijgen, en
    - die wiens moeders sedativa of opiaten kregen voor of tijdens de bevalling zullen de eerste 2 dagen na de partus worden geexcludeerd
    - zij die reeds eerder meededen aan de studie
    E.5 End points
    E.5.1Primary end point(s)
    The main study endpoint in this study is the optimal dose of propofol for
    each age group of newborns. The optimal dose of propofol is determined
    by 3 outcome variables: level of sedation, quality of intubation and
    The optimal dose as determined in the first phase (phase A) of our study
    will be validated in the 2nd part of our study (phase B).
    Leeftijdspecifieke propofol dosis richtlijnen
    E.5.1.1Timepoint(s) of evaluation of this end point
    After every 5 patients per age group have been included the 3 primary
    outcome measures of those 5 patients are evaluated and analysed. The
    result of that analyses will determine the dose of propofol for the next 5
    patients of the that specific age category. If the used dose in the 5
    patients results in adeqaute sedation, good intubation conditions and no
    hypotension or other clinically significant side effect the dose is
    evaluated as appropriate. This will be re-evaluated in another 5 patients
    of the same age to validate the dose and to determine it as optimal
    propofol single dose for that age category.
    Na elke 5 geincludeerde patienten per groep zal een tussen analyse plaatsvinden om te analyseren of de dosis optimaal is
    E.5.2Secondary end point(s)
    A secondary endpoint of this study is the development of a validated and
    useful sedation assessment instrument for (preterm) newborns during
    endotracheal intubation. For this endpoint validated pain assessment
    instruments (COMFORTneo, nPASS, PIPP and NIPS) will be compared
    with an available sedation score[31] by the use of videotapes. The
    validity of the sedation scores is determined by comparison with saliva
    cortisol levels.
    An age specific PK/PD (pharmacokinetic/pharmacodynamic) model for propofol is created by evaluation of propofol blood levels and
    incorporation into a non-lineair-mixed effects modeling (NONMEM)
    Genotypic explanations for inter-individual variability in propofol
    concentrations and effects of propofol by determination of variability in
    genes encoding propofol metabolizing enzymes (UGT 1A9 and CYP 2B6)
    and GABA receptors.
    - Een gevalideerd en bruikbaar instrument om sedatie te meten bij pasgeborenen tijdens intubatie
    - Een farmacokinetiek/farmacodynamiek model voor neonatal propofol
    - Vaststellen relatie genotype en fenotype voor propofol
    - Vaststellen effecten van propofol op cerebrale perfusie
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study
    Einde van de studie
    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 Yes
    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. 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 No
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E. trial design description
    Dosis optimalisatie middels step-up en step-down design
    Dose optimaizing study with step-up and step-down design
    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.8.2.4Number of treatment arms in the trial1
    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 concerned3
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 160
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F. of subjects for this age range: 120
    F.1.1.3Newborns (0-27 days) Yes
    F. of subjects for this age range: 40
    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 No
    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. of subjects incapable of giving consent
    The current trial will include only patients that are newborn (both
    preterm and term) and admitted to the neonatal intensive care unit. In
    those specific patients propofol is already used as part of standard of
    De huidige studie zal alleen patienten includeren die pasgeboren zijn (zowel te vroeg als voldragen) en die opgenomen zijn op een intensive care afdeling.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state160
    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)
    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 Decision2014-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-21
    P. End of Trial
    P.End of Trial StatusOngoing
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