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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2015-001668-21
    Sponsor's Protocol Code Number:FDE_2014_25
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2024-07-03
    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 ConcernedFrance - ANSM
    A.2EudraCT number2015-001668-21
    A.3Full title of the trial
    Addition of neuromuscular-blocking agents during induction in infants: potential interest in reducing hypoxia episodes
    Intérêt du curare pour diminuer les épisodes d’hypoxémie lors de l’intubation chez l’enfant de moins de 2 ans
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Addition of neuromuscular-blocking agents during induction in infants: potential interest in reducing episodes of oxygen decrease in blood
    Intérêt du curare pour diminuer les épisodes de baisse d'oxygène dans le sang lors de l’intubation chez l’enfant de moins de 2 ans
    A.3.2Name or abbreviated title of the trial where available
    ROC-HYPOX
    ROC-HYPOX
    A.4.1Sponsor's protocol code numberFDE_2014_25
    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 SponsorFondation Ophtalomologique A. de Rothschild
    B.1.3.4CountryFrance
    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 supportFondation Ophtalomologique A. de Rothschild
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondation Ophtalmologique A. de Rothschild
    B.5.2Functional name of contact pointUnité de Recherche Clinique
    B.5.3 Address:
    B.5.3.1Street Address25 rue Manin
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75019
    B.5.3.4CountryFrance
    B.5.6E-maillsalomon@fo-rothschild.fr
    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 ESMERON
    D.2.1.1.2Name of the Marketing Authorisation holderMSD FRANCE
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNROCURONIUM BROMIDE
    D.3.9.3Other descriptive nameROCURONIUM BROMIDE
    D.3.9.4EV Substance CodeSUB10353MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chirurgie programmée sous anesthésie générale avec intubation orotrachéale, avec induction inhalatoire prévue
    Scheduled surgery under general anesthesia with orotracheal intubation, with planned inhalational induction
    E.1.1.1Medical condition in easily understood language
    Surgery under general anesthesia with placement of a tube into the trachea for which the child is asleep by an inhaled product mask before applying the infusion.
    Chirurgie programmée sous anesthésie générale avec pose d'un tube dans la trachée, pour laquelle l'enfant est endormi par un produit inhalé sous masque avant la pose de la perfusion.
    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 21.0
    E.1.2Level LLT
    E.1.2Classification code 10002326
    E.1.2Term Anesthetic induction
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Demonstrate that adding rocuronium (0,3 mg.kg-1) to the sevoflurane-6 % and sufentanil 0,1 mcg.kg-1 anaesthetic protocole reduces the incidence of hypoxemia while intubating infants aged 1-24 months
    Démontrer que l’ajout de rocuronium (0,3 mg.kg-1) au protocole d’anesthésie inhalatoire, associant sévoflurane 6% et sufentanil 0,1 mcg.kg-1 permet de réduire la survenue d’hypoxémie lors de l’intubation chez l’enfant de moins de 2 ans.
    E.2.2Secondary objectives of the trial
    Search the impact of curare administration on the incidence of respiratory events (bronchospasm, laryngospasm, prolonged apnea duration)
    Search link between intubating conditions (assessed by the score of Copenhagen) and incidence, intensity and duration of hypoxemia, as well as the occurrence of respiratory events
    Rechercher l’impact de l’administration de curare sur l’incidence d’évènements respiratoires (bronchospasme, laryngospasme, durée d’apnée prolongée)
    Rechercher un lien entre les conditions d’intubation (évaluées par le score de Copenhague) et l’incidence, l’intensité et la durée d’une hypoxémie, ainsi que sur la survenue d’évènements respiratoires
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age <2 years
    - Indication of general anesthesia with orotracheal intubation
    - Inhalational induction scheduled
    - Free, written and informed consent of both parents to participate in the study
    - âge < 2 ans
    - indication d’anesthésie générale avec intubation orotrachéale
    - induction inhalatoire prévue
    - consentement libre, écrit et éclairé des deux parents pour participer à l’étude
    E.4Principal exclusion criteria
    - Contraindication to:
    . inhalation induction (stomach full)
    . the use of rocuronium (intubating scheduled difficult, documented allergy ...)
    - ASA III or IV
    - Intracranial surgery
    - parental refusal
    - no affiliation to French public wellfare system
    - Contre-indication à :
    . l’induction inhalatoire (estomac plein),
    . l’utilisation de rocuronium (intubation prévue difficile, allergie documentée...)
    - ASA III ou IV
    - chirurgie intra-crânienne
    - refus parental
    - absence d’affiliation à la sécurité sociale
    E.5 End points
    E.5.1Primary end point(s)
    Incidence rate of hypoxemia, defined as a blood oxygen saturation <90%, obtained by continuous measurement of pulse oximetry (SpO2) at any time between the injection of rocuronium or placebo and 5 minutes after completion intubation
    Taux d’incidence de l’hypoxémie, définie par une saturation artérielle en oxygène < 90%, obtenue par mesure continue de l’oxymétrie pulsée (SpO2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At any time between the injection of rocuronium or placebo and 5 minutes after completion intubation ( paritcipation time = 1 hour)
    A tout moment entre l’injection de rocuronium ou placebo et 5 minutes après la complétion de l’intubation (durée de participation = 1 heure)
    E.5.2Secondary end point(s)
    1 / respiratory events:
    . cumulative duration of hypoxemia (time with SpO2 <90%),
    . cumulative time with decreased SpO2 5% relative to the SpO2 before intubation
    . lowest value recorded SpO2
    . bronchospasm
    . laryngospasm
    . Apnea time (time with no ETCO2 curve)
    2 / intubating conditions
    . Copenhagen score
    . term intubation
    . number of intubation attempts
    3 / hemodynamic events
    . change> 30% of the heart rate and mean arterial pressure
    4 / incidence of residual paralysis (monitoring by train 4 to the adductor inch)
    5 / incidence of pharmacological reversal necessitated by residual paralysis
    1/ Evènements respiratoires :
    . durée cumulée d’hypoxémie (temps avec SpO2< 90%),
    . durée cumulée avec une SpO2 diminuée de 5% par rapport à la SpO2 avant intubation
    . valeur la plus basse enregistrée de SpO2
    . bronchospasme
    . laryngospasme
    . durée d’apnée (durée avec absence de courbe de ETCO2)
    2/ conditions d’intubation
    . score de Copenhague
    . durée d’intubation
    . nombre de tentatives d’intubation,
    3/ évènements hémodynamiques
    . variation > 30% de la fréquence cardiaque et de la pression artérielle moyenne
    4/ incidence de la curarisation résiduelle (monitorage par train de 4 à l’adducteur du pouce)
    5/ incidence de la décurarisation pharmacologique nécessitée par la curarisation résiduelle
    E.5.2.1Timepoint(s) of evaluation of this end point
    At any time between the injection of rocuronium or placebo and 5 minutes after completion intubation ( paritcipation time = 1 hour)
    A tout moment entre l’injection de rocuronium ou placebo et 5 minutes après la complétion de l’intubation (durée de participation = 1 heure)
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 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 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 concerned4
    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
    Dernière visite du dernier patient inclus
    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 months
    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: 412
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 412
    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 : subjects under age incapable of giving consent personally
    Nourissons
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state412
    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
    aucun
    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 Decision2015-08-19
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusCompleted
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