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    Summary
    EudraCT Number:2016-000649-30
    Sponsor's Protocol Code Number:P150905
    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:2016-06-20
    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 number2016-000649-30
    A.3Full title of the trial
    Impact of the administration of Fludrocortisone the fluid and electrolyte balance in great premature. Pilot study.
    Impact de l’administration de Fludrocortisone sur la balance hydro-électrolytique chez le grand prématuré. Etude pilote.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Fludrocortisone in great premature babies.
    Fludrocortisone chez grand prématuré.
    A.3.2Name or abbreviated title of the trial where available
    MINIPREM
    A.4.1Sponsor's protocol code numberP150905
    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 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 supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.5.2Functional name of contact pointDRCD Hôpital St Louis
    B.5.3 Address:
    B.5.3.1Street Address 1 av. Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.6E-mailsophie.courtial-destembert@aphp.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 No
    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 nameFludrocortisone
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGastroenteral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFludrocortisone
    D.3.9.3Other descriptive nameFludrocortisone
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    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 placeboTablet
    D.8.4Route of administration of the placeboGastroenteral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Great prematurity
    Grande prématurité
    E.1.1.1Medical condition in easily understood language
    Great newborn babies
    Enfants grands prématurés
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10053593
    E.1.2Term Premature baby 26 to 32 weeks
    E.1.2System Organ Class 100000004868
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of supplementation by Fludrocortisone (mineralocorticoid agonist) versus placebo in H24 (24 hours of life corresponding to D1) D8 (8th day of life) to D3 on sodium excretion in children born great premature (before 32 weeks of amenorrhea).
    Evaluer l'efficacité de la supplémentation par Fludrocortisone (agoniste minéralocorticoïde), versus placebo, de H24 (24 heures de vie correspondant à J1) à J8 (8ème jour de vie) sur l'excrétion urinaire de sodium à J3 chez les enfants nés grands prématurés (avant 32 SA).
    E.2.2Secondary objectives of the trial
    To evaluate the effect and safety of substitution Fludrocortisone of H24 to D8 versus placebo in very premature babies:
    - Short term (D1 to D15) on the electrolyte balance and renal mineralocorticoid action level; blood pressure and weight; the number of blood tests performed in this period
    - In the medium term up to 36 weeks post-conceptional on blood pressure, weight, mineralocorticoid function, major morbidity indicators of extremely premature
    - Long-term (up to M12) on blood pressure, weight, mineralocorticoid action kidneys
    - PK of Fludrocortisone in very premature infants during the first 8 days of life
    - Validation of the urinary ratio: Aldosterone / Na at D0 as a predictive index sodées losses in population control and as a predictive index for renal mineralocorticoid sensitivity in the treated population D3 life.
    Evaluer l'effet et la tolérance de la substitution par Fludrocortisone de H24 à J8, versus placebo, chez les enfants nés grands prématurés :
    - à court terme J1 à J15 sur l'équilibre hydroélectrolytique et l'action minéralocorticoïde au niveau rénal, la tension artérielle et le poids, le nombre de prises de sang effectuées durant cette période
    - à moyen terme jusqu'à 36 semaines post-conceptionnelles sur la tension artérielle, le poids, la fonction minéralocorticoïde, les principaux indicateurs de morbidité du grand prématuré
    - à long terme jusqu'à M12 sur la tension artérielle, le poids, l'action minéralocorticoïde au niveau rénal
    - PK de la Fludrocortisone chez le grand prématuré pendant les 8 premiers jours de vie
    - Validation du rapport urinaire Aldostérone / Na à J0 comme index prédictif des pertes sodées dans la population contrôle et comme index prédictif de la sensibilité minéralocorticoïde rénale dans la population traitée à J3 de vie
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Very premature newborns defined by a gestational age <32 weeks of amenorrhea and >= 26 weeks of amenorrhea
    - Eutrophic: weight between 10th and 90th percentile on the French reference curves AUDIPOG
    - Absence of defects or chromosomal abnormality identified
    - Lack of adrenal disease, pituitary gonadal or for prenatal diagnosis
    - Lack of participation in another research protocol
    - Children born and hospitalized in the four neonatology services participating in the study
    - Informed consent of the holders of the exercise of parental authority
    - nouveau-nés grands prématurés défini par un âge gestationnel < 32 SA et >= 26 SA
    - eutrophe : poids entre 10ème et 90ème percentile sur les courbes de références françaises AUDIPOG
    - absence de malformation ou d'anomalie chromosomique identifiée
    - absence de pathologie surrénalienne, gonadique ou hypophysaire de diagnostic anténatal
    - absence de participation à un autre protocole de recherche
    - " inborn " : né et hospitalisé dans un des quatre services de néonatologie participant à l'étude
    - consentement éclairé des titulaires de l'exercice de l'autorité parentale
    E.4Principal exclusion criteria
    - Maternal treatment prior to pregnancy: systemic or inhaled corticosteroids, hormone therapy for adrenal or pituitary insufficiency, antihypertensive treatment (calcium channel blockers, beta blockers, angiotensin)
    - Lack or incomplete treatment of antenatal glucocorticoids (betamethasone)
    - traitement maternel avant le début de la grossesse : corticothérapie systémique ou inhalée, traitement hormonal pour insuffisance surrénalienne ou hypophysaire, traitement anti-hypertenseur (inhibiteurs calciques, bêta-bloquants, inhibiteur de l'angiotensine),
    - absence ou cure incomplète de glucocorticoïdes anténatale (bétaméthasone)
    E.5 End points
    E.5.1Primary end point(s)
    Main: measuring the Na / urinary creatinine ratio at D3 (indicating kidney action Fludrocortisone and lower sodées losses) on the urine collection pad, placed in the layer of the newborn.
    Principal : mesure du rapport Na/créatinine urinaire à J3 (témoignant d'une action rénale de la Fludrocortisone et d'une diminution des pertes sodées) par recueil urinaire sur compresse, placée dans la couche du nouveau-né.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 3
    Jour 3
    E.5.2Secondary end point(s)
    secondary:
    1 Efficiency:
    -quantification of sodium urinary losses (Na / creat urinary ratio) to D1, D3, D5, D8, D10 and D15
    -quantification of fluid intake (ml / kg / day) and sodium intake (mEq / kg / d) of D1 to D8, D10 and D15
    -rated serum sodium and potassium levels in D1, D3, D8 and D15
    -measure plasma renin on D1, D3, D8 and D15
    - quantification of the number of blood tests performed in this period
    -rated complications occurred up to 36 WPC corrected age, based on clinical and exam results achieved under the care:
    opersistance of ductus arteriosus at echocardiography between D2 and D5 and between D7 and D15
    ointraventricular hemorrhage at trans-fontanel ultrasound between D2 and D5 and between D7 and D15 and at 36 WPC
    obronchopulmonary dysplasy evaluated by a need for FiO2> 21% at D28 and severity assessed by the Walsh test conducted at 36 WPC
    oduration in days of intubation invasive and non-invasive
    oulcerous and necrotizing enterocolitis
    -Persistance of ductus arteriosus at echocardiography between D2 and D5 and between D7 and D15
    -Presence of intraventricular hemorrhage in the trans-fontanel ultrasound (ETF) between D2 and D5, and between D7 and D15, and at the age of 36 WPC
    -Duration In days of invasive and non-invasive intubation
    -Need in FiO2> 21% at D28 and Walsh test made at 36 WPC.
    2 Tolerance:
    -Arterial tension and weight gain in newborns from D1 to D8, at D10, at D15 and at the age of 36 WPC.
    -Arterial tension, weight and urinary dosage of aldosterone and cortisol in M1, M3, M6 and actual age M12 (non-invasive measurement of urine collection by compress)
    3 Pharmacokinetics:
    -Settings pharmacokinetics of Fludrocortisone by plasma measurement at D1 and D3 or at D8 (EDTA tube, same tube as for renin, which will be done at the same time at D1, D3 or D8), total volume <= 0.5 ml):
    oat D1 after the first dose of the experimental treatment (2 samples from umbilical catheter, the first between 0 and 3 hours after administration of the experimental treatment and the second between 3 and 6 hours or between 6 and 12 hours after administration).
    oat D3 or D8, within 4 hours after taking the experimental treatment (at the time of a sample taken under the care)
    -Urinary elimination of Fludrocortisone by mass spectrometry assay non invasive collection of compresse made 4 hours after administration of the experimental treatment on D1, D3, D5 and D8. Urinary elimination of Fludrocortisone by mass spectrometry assay non invasive collection of compresse made 48 hours after the last administration of the experimental treatment or at D10.
    4 Validation of the urinary index:
    Aldosterone / Na at D0 (before H24, at the time of inclusion) as a predictive index of future sodium losses:
    -compared to urinary Na determinations at D3, D8 and at D15 in the control population
    -compared to urinary Na determinations at D3, D8 and at D15 in the treated population.
    Secondaires :
    1 Efficacité :
    -quantification des pertes sodées urinaires (rapport Na/creat urinaire) à J1, J3, J5, J8, J10 et J15
    -quantification des apports hydriques (en ml/kg/j) et sodés (en mEq/kg/j) de J1 à J8, J10 et à J15
    -évaluation de la natrémie et de la kaliémie à J1, J3, J8 et J15
    -mesure de la rénine plasmatique à J1, J3, J8 et J15
    - quantification du nombre de prises de sang effectuées durant cette période
    -évaluation des complications survenues jusqu'à 36 SPC d'âge corrigé, basées sur la clinique et les résultats des examens réalisés dans le cadre du soin :
    oPersistance du canal artériel à l'échographie cardiaque entre J2 et J5 et entre J7 et J15
    oHémorragie intra-ventriculaire à l'échographie trans-fontanellaire entre J2 et J5, et entre J7 et J15 et à 36 SPC
    oDysplasie broncho-pulmonaire évaluée par un besoin en FiO2 > 21% à J28 et degré de sévérité évaluée par le test de Walsh réalisé à 36 SPC
    oDurée en jours d'intubation invasive et non invasive
    oEntérocolite ulcéro-nécrosante
    -Persistance du canal artériel à l'échographie cardiaque entre J2 et J5 et entre J7 et J15
    -Présence d'une hémorragie intra-ventriculaire à l'échographie trans-fontanellaire (ETF) entre J2 et J5, et entre , J7,et J15 et à l'âge de 36 SPC
    -Durée en jours d'intubation invasive et non invasive
    -Besoin en FiO2 > 21% à J28 et test de Walsh réalisé à 36 SPC.
    2 Tolérance :
    -Tension artérielle et prise pondérale chez le nouveau-né de J1 à J8, à J10, J15 et à l'âge de 36 SPC.
    -Tension artérielle, poids et dosage urinaire de l'aldostérone et du cortisol à M1, M3, M6 et M12 d'âge réel (mesure non invasive par recueil des urines sur compresse)
    3 Pharmacocinétique :
    -Paramètres pharmacocinétiques de la Fludrocortisone par mesure plasmatique à J1 et J3 ou J8 (tube EDTA, même tube que pour la rénine, qui sera prélevée au même moment à J1, J3 ou J8), volume total <= 0.5 ml):
    oà J1 après la première prise de traitement expérimental (2 prélèvements sur cathéter ombilical KTVO, le premier entre 0 et 3 heures après l'administration du traitement expérimental puis le deuxième entre 3 et 6 heures ou entre 6 et 12 heures après l'administration).
    oà J3 ou J8, dans les 4 heures après la prise du traitement expérimental (au moment d'un prélèvement réalisé dans le cadre du soin)
    -Elimination urinaire de la Fludrocortisone par dosage en spectrométrie de masse sur recueil non invasif sur compresse réalisé 4 heures après l'administration du traitement expérimental à J1, J3, J5 et J8. Elimination urinaire de la Fludrocortisone par dosage en spectrométrie de masse sur recueil non invasif sur compresse réalisé 48 heures après la dernière administration du traitement expérimental soit à J10.
    4 Validation de l'index urinaire :
    Aldostérone / Na à J0 (avant H24, au moment de l'inclusion) comme index prédictif des futures pertes sodées :
    - comparé aux dosages de Na urinaires à J3, J8 et J15 dans la population contrôle
    - comparé aux dosages de Na urinaires à J3, J8 et J15 dans la population traitée.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 12
    Mois12
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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
    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 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.1.1Number of subjects for this age range: 66
    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: 66
    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 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
    Newborn
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state66
    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
    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 Decision2016-09-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-29
    P. End of Trial
    P.End of Trial StatusCompleted
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