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    Summary
    EudraCT Number:2013-001850-83
    Sponsor's Protocol Code Number:2012/175/HP
    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:2015-09-24
    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 number2013-001850-83
    A.3Full title of the trial
    Adaptation to neonatal life after an anesthetic protocol using remifentanil for general anesthesia for caesarean section in a context of prematurity - REAGI Protocol (Remifentanil for General Anesthesia in the context of Immaturity)
    Répercussions sur l'adaptation à la vie néonatale de l'utilisation du rémifentanil au cours d'un protocole d'anesthésie générale pour césarienne dans un contexte de prématurité – Protocole REAGI (REmifentanil pour Anesthésie Générale en contexte d'Immaturité)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Adaptation to neonatal life after an anesthetic protocol using remifentanil for general anesthesia for caesarean section in a context of prematurity - REAGI Protocol (Remifentanil for General Anesthesia in the context of Immaturity)
    Répercussions sur l'adaptation à la vie néonatale de l'utilisation du rémifentanil au cours d'un protocole d'anesthésie générale pour césarienne dans un contexte de prématurité – Protocole REAGI (REmifentanil pour Anesthésie Générale en contexte d'Immaturité)
    A.3.2Name or abbreviated title of the trial where available
    REAGI
    REAGI
    A.4.1Sponsor's protocol code number2012/175/HP
    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 SponsorCHU- Hôpitaux de Rouen
    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 supportCHU- Hôpitaux de Rouen
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU- Hôpitaux de Rouen
    B.5.2Functional name of contact pointSouplet Fizet Laetitia
    B.5.3 Address:
    B.5.3.1Street AddressDRCI, 1 rue de Germont
    B.5.3.2Town/ cityRouen
    B.5.3.3Post code76031
    B.5.3.4CountryFrance
    B.5.4Telephone number+33232888265
    B.5.5Fax number+33232888287
    B.5.6E-maillaetitia.souplet-fizet@chu-rouen.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 ultiva
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATOIRE GLAXOSMITHKLINE
    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 Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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 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
    pregnant woman older than 18 years with an indication for caesarean section under general anesthesia in a context of prematurity.
    Patiente de plus de 18 ans porteuse d’une grossesse simple ayant une indication à une césarienne sous anesthésie générale en contexte de prématurité
    E.1.1.1Medical condition in easily understood language
    pregnant woman older than 18 years with an indication for caesarean section under general anesthesia in a context of prematurity
    Patiente de plus de 18 ans porteuse d’une grossesse simple ayant une indication à une césarienne sous anesthésie générale en contexte de prématurité
    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 18.0
    E.1.2Level HLGT
    E.1.2Classification code 10026908
    E.1.2Term Maternal complications of pregnancy
    E.1.2System Organ Class 10036585 - Pregnancy, puerperium and perinatal conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare the clinical condition of the children born by cesarean section under general anesthesia with remifentanil administration, as assessed by the Apgar score at 5 min, to that of children born by cesarean section under general anesthesia without the use of morphine before clamping the umbilical cord.
    Comparer l’état clinique, évalué par le score d’Apgar à 5 min, des enfants nés de césariennes sous anesthésie générale avec administration de rémifentanil à celui des enfants nés de césariennes sous anesthésie générale sans utilisation de morphinique avant le clampage du cordon ombilical.
    E.2.2Secondary objectives of the trial
    - Confirm the best haemodynamic control in mothers treated with remifentanil.
    - Evaluate the frequency of use of adjuvant anesthetic agents before cord clamping.
    - Confirm the absence of clinical impact of the use of remifentanil in children in the 2 first years of life.
    - Confirmer le meilleur contrôle hémodynamique chez les mères traitées par rémifentanil.
    - Evaluer la fréquence d’utilisation d’agents anesthésiques d’entretien avant clampage du cordon.
    - Confirmer l’absence d’impact clinique de l’utilisation de rémifentanil chez les enfants à moyen terme.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria of the mother:
    - Patient over 18 years
    - Single pregnancy with an indication for cesarean section under general anesthesia context of prematurity (<37SA)
    - Patient informed and written consent for participation in this research signed
    - Affiliation to social security

    Inclusion criteria of the child:
    Parents informed and written consent signed by the father and mother for the participation in this research by the child (unless a parent no longer has parental authority)
    Critères d'inclusion de la patiente:
    - Patiente de plus de 18 ans,
    - Patiente porteuse d’une grossesse simple ayant une indication à une césarienne sous anesthésie générale en contexte de prématurité (<37SA)
    -Patiente informée et ayant signé un consentement écrit pour sa participation à cette recherche
    - Affiliation à un régime de sécurité sociale

    Critères d'inclusion de l'enfant:
    Parents informés et consentement écrit signés par le père et la mère pour la participation de l'enfant à cette recherche (sauf si un des parents ne possède plus l'autorité parentale)
    E.4Principal exclusion criteria
    Non-inclusion criteria of the mother:
    - Vaginal Delivery
    - Mother pathology requiring the use of an opioid during induction
    - Severe Preeclampsia
    - More than 14 weeks between the information and the inclusion
    - Patient under guardianship

    Non-inclusion criteria of the child:
    Fetal pathology diagnosed in the prenatal period involving the prognosis of the child
    Critères de non-inclusion de la patiente:
    - Accouchement par voie basse
    - Pathologie maternelle nécessitant l’utilisation d’un morphinique à l’induction
    - Pré-éclampsie sévère
    - Délais de plus de 14 semaines entre l’information et l’inclusion
    - Patiente sous tutelle ou curatelle

    Critères de non-inclusion de l'enfant:
    Pathologie fœtale diagnostiquée dans la période prénatale mettant en jeu le pronostic vital de l'enfant
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    Apgar Score value below 7 after 5 minutes calculated in the delivery room by the team supporting the child (midwives or pediatric).
    Critère principal:
    Valeur du score d’Apgar inférieure à 7 de 5 minutes, calculé en salle de naissance par l’équipe prenant en charge l’enfant (sages-femmes ou pédiatres).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary end point is evaluated at 5 min
    le critère principal d'évaluation est évalué à 5 min.
    E.5.2Secondary end point(s)
    Secondary endpoints:
    - Maternal hemodynamic parameters (SBP, DBP, MAP, HR),
    - Rate of complications of induction (difficult intubation, inhalation)
    - Occurrence of respiratory distress requiring mask ventilation of the newborn
    - Intubation rate among newborns
    - Rate of the use of adjuvant anesthetic agents.
    Critères secondaires:
    - Paramètres hémodynamiques maternels: (PAS, PAD, PAM, Fc),
    - Taux de complications à l’induction (intubation difficile, inhalation),
    - Survenue d’une détresse respiratoire nécessitant une ventilation au masque chez le nouveau-né
    - Taux d’intubation chez les nouveaux-nés ,
    - Taux d’utilisation d’agents anesthésiques d’entretien.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary end point(s) are evaluated at Day 0
    tout les critères secondaires sont évalués à J0.
    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 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 No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 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
    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 years4
    E.8.9.1In the Member State concerned months6
    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: 60
    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: 60
    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) Yes
    F.1.2.1Number of subjects for this age range: 60
    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 Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    newborn infants
    les nouveaux nés
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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 Decision2013-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-22
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