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    Summary
    EudraCT Number:2013-005043-86
    Sponsor's Protocol Code Number:1308143
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-06-17
    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 number2013-005043-86
    A.3Full title of the trial
    Reactivity of the autonomic nervous system after a nociceptive stress in the newborn: Interest of sucrose and non-nutritive sucking.
    Réactivité du système nerveux autonome après un stress nociceptif chez le nouveau-né : Intérêt du sucrose et de la succion non nutritive.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Reactivity of the autonomic nervous system after a nociceptive stress in the newborn: Interest sucrose and non-nutritive sucking.
    Réactivité du système nerveux autonome après un stress nociceptif chez le nouveau-né : Intérêt du sucrose et de la succion non nutritive.
    A.3.2Name or abbreviated title of the trial where available
    BB SUCROSE
    A.4.1Sponsor's protocol code number1308143
    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 de Saint-Etienne
    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 de Saint-etienne
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Saint-Etienne
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressMaison de la Recherche - Hôpital NORD
    B.5.3.2Town/ citySAINT-ETIENNE Cedex 2
    B.5.3.3Post code42055
    B.5.3.4CountryFrance
    B.5.4Telephone number330477120286
    B.5.5Fax number330477127820
    B.5.6E-mailagarcin34@yahoo.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 Glucose PROAMP 30%
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoire AGUETTANT
    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 IMPOral 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 injection
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    E.1.1.1Medical condition in easily understood language
    newborn
    Nouveau-né
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10051566
    E.1.2Term Fasting blood glucose
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Describe the short-term responsiveness of the autonomic nervous system, during a nociceptive action in the newborn motherhood is different depending on whether it is preceded by non-nutritive sucking and / or administration of sucrose
    Montrer que la réactivité à court terme du système nerveux autonome, au décours d’un geste nociceptif chez le nouveau-né en maternité est différente selon que ce dernier est précédé de succion non nutritive et/ou d’administration de sucrose
    E.2.2Secondary objectives of the trial
    Describe subjective perceptions (EDIN) and objective (ANI) pain during a nociceptive action in the newborn are different depending on whether this action is preceded by non-nutritive sucking and / or administration of sucrose
    Montrer que les perceptions subjectives (EDIN) et objectives (ANI) de la douleur au décours d’un geste nociceptif chez le nouveau-né sont différentes selon que ce geste est précédé de succion non nutritive et/ou d’administration de sucrose
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age < 8 days
    - hospitalised in lmotherhood unit of CHU of Saint-Etienne
    - to receive a dextrostix right or left heel for analysis of blood glucose
    - consent form signed by parents
    - Nourrisson de moins de 8 jours hospitalisé en service de maternité du CHU de St-Etienne, devant recevoir un dextrostix au talon droit ou gauche pour analyse de sa glycémie capillaire.
    - Recueil du formulaire de consentement signé du titulaire de l’autorité parentale.
    E.4Principal exclusion criteria
    - Children suffering from a disease of the central nervous system.
    - Children treated with paracetamol oral solution or other analgesic (nalbuphine) or sedative at the time of registration.
    - Newborns impregnated by maternal analgesia perpartum.
    - Enfant atteint d’une pathologie affectant le système nerveux central.
    - Enfant traité par Paracétamol en solution buvable (en cas de céphalhématome par exemple) ou par tout autre antalgique (nalbuphine) ou sédatif, au moment de l’enregistrement.
    - Nouveau-nés imprégnés par une analgésie maternelle perpartum.
    E.5 End points
    E.5.1Primary end point(s)
    high frequency normalized index (HFnu) Variability RR short-term heart rate (HRV)
    indice haute fréquence normalisé (HFnu) de Variabilité RR à court terme de la fréquence cardiaque (HRV) dans le domaine fréquentiel
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the dextrostix
    Au moment de la réalisation du dextrostix
    E.5.2Secondary end point(s)
    - Other indices of RR variability of heart rate (HRV) in the frequency domain (total power of the frequency spectrum (Ptot), low frequency (LF and LFnu), high frequency (HF) ratio LF / HF) and in the time domain (SDNN, SDANN, Pnn50).
    - Index (ANI analgesia-nociception) from the MetroDoloris© monitor
    - Scale hetero-assessment of pain: EDIN
    - Features electro acoustic crying newborn: duration, frequency, frequency variations
    - Autres indices de Variabilité RR de la fréquence cardiaque (HRV) dans le domaine fréquentiel (puissance totale du spectre de fréquence (Ptot), basse fréquence (LF et LFnu), haute fréquence (HF), ratio LF/HF) et dans le domaine temporel (SDNN, SDANN, Pnn50).
    - Indice ANI (analgésie-nociception) à partir du moniteur Metrodoloris© (Annexe 3)
    - Echelle d’hétéro-évaluation de la douleur : Grille d’évaluation de la douleur aiguë du nouveau-né (EDIN) (Annexe 2)
    - Caractéristiques électro acoustiques des pleurs des nouveau-nés : durée, fréquence, variations de fréquence (Annexe 6)
    E.5.2.1Timepoint(s) of evaluation of this end point
    at the dextrostix
    Au moment de la réalisation du dextrostix
    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 No
    E.6.4Safety No
    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) 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 trial3
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    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: 180
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 180
    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 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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Minors
    Mineurs
    F.4 Planned number of subjects to be included
    F.4.1In the member state180
    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)
    Nono
    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 Decision2014-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-13
    P. End of Trial
    P.End of Trial StatusOngoing
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