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    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   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:2007-002041-20
    Sponsor's Protocol Code Number:P060250
    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:2007-10-25
    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 number2007-002041-20
    A.3Full title of the trial
    Essai de prévention de la dysplasie broncho-pulmonaire par l'hydrocortisone postnatale précoce chez le très grand prématuré
    A.3.2Name or abbreviated title of the trial where available
    PREMILOC
    A.4.1Sponsor's protocol code numberP060250
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 HYDROCORTISONE UPJOHN 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderLaboratoires SERB
    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 nameHYDROCORTISONE UPJOHN 100 mg
    D.3.4Pharmaceutical form Powder for injection*
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNHémisuccinate d'hydrocortisone
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100 mg
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboPowder for injection*
    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
    Prématurité : Nouveau né d'âge gestationnel compris entre 24+0 et 27+6 semaines d'aménorrhée
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10036590
    E.1.2Term Grande prématurité
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Tester l'utilité de l'administration précoce de l'HSHC chez de grands prématurés nés dans un contexte d'infection périnatale sur la baisse de mortalité néonatale et la survenue de la dysplasie broncho-pulmonaire (DBP) définie comme le besoin d'un soutien ventilatoire et/ou l'administration d'oxygène à 36 SA.
    E.2.2Secondary objectives of the trial
    -Déterminer l'impact de l'HSHC sur : La DBP à 28 j, la mortalité néonatale , les différents stades de gravité de la DBP, les complications respiratoires précoces, la durée de ventilation, d'oxygéno-dépendance et durée d'hospitalisation avant le retour à domicile, le recours à la corticothérapie postnatale systémique au-delà de la période de Tt par HSHC
    -Evaluer la morbidité extra-respiratoire
    -Le nombre et la durée des réhospitalisations au-delà de 36 SA, déterminée à 1 et 2 ans d'âge chronologique,
    -La tolérance de l'administration précoce de l'HSHC.
    -Analyse prospective de l'intérêt de la CRP, des interleukines et de la procalcitonine dans le diagnostic biologique de chorioamniotite,
    -Bilan thyroïdien
    -Test à l'ACTH 48h après la fin du traitement
    -Vérification anatomo-pathologique du diagnostic clinico-biologique a priori de chorioamniotite,
    -Dvlpt neuromoteur et psychologique à 2 ans d'âge chronologique,
    -Les coûts hospitaliers estimés pour la durée totale du suivi.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Examen médical préalable
    -Tout nouveau-né d'âge gestationnel compris entre 24+0 et 27+6 semaines d'aménorrhée nés dans un contexte autre que ceux indiqués dans les critères d'exclusion.
    -Enfant dont les titulaires de l'autorité parentale ont signé un consentement
    -Enfant dont les titulaires de l'autorité parentale sont affiliés à un régime de sécurité sociale ou CMU*
    E.4Principal exclusion criteria
    -prématurés nés d'âge gestationnel >ou = 28 semaines d'aménorrhée
    -Malformation congénitale et/ou cardiaque autre que canal artériel ou foramen ovale
    -Rupture des membranes avant 22+0 semaines d'aménorrhée
    -Enfant issu d'une grossesse de rang supérieur à 3
    -Enfant dont le poids de naissance est inférieur à 500g
    -RCIU < 3ème percentile selon les courbes postnatales d'AUDIPOG
    -Enfant " OUTBORN " né en dehors des centres recruteurs
    -Enfant dont les titulaires de l'autorité parentale sont mineurs
    -Enfant qui ne sera pas en mesure de recevoir la totalité du traitement (anomalie chromosomique, asphyxie sévère à la naissance)
    -Enfant dont les titulaires de l'autorité parentale ne sont pas bénéficiaires d'un régime de sécurité sociale
    E.5 End points
    E.5.1Primary end point(s)
    Tout enfant prématuré survivant sans dysplasie broncho-pulmonaire à 36 semaines d'aménorrhée sera un " succès ".
    Tout enfant prématuré décédé ou survivant mais oxygéno-dépendant ou dépendant d'un mode ventilatoire qu'elle que soit la FiO2 à 36 semaines d'aménorrhée sera un " échec ".
    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.8.3 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 concerned27
    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 Information not present in EudraCT
    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 years4
    E.8.9.1In the Member State concerned months0
    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.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state786
    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 Decision2008-01-11
    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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