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    Summary
    EudraCT Number:2018-004946-41
    Sponsor's Protocol Code Number:SP-PP18
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-004946-41
    A.3Full title of the trial
    Personalized Versus Standardized Parenteral Nutrition for Preterm Infants With a Birth Weight Greater Than 1250 Grams: a Multicenter Randomized Phase IV Clinical Trial
    Nutrizione parenterale personalizzata versus standard per neonati pretermine con peso neonatale maggiore di 1250 grammi: un trial clinico multicentrico randomizzato di fase IV.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Personalized versus standard intravenous nutrition for small preterm infants
    Nutrizione endovenosa personalizzata versus standard per neonati prematuri con basso peso
    A.3.2Name or abbreviated title of the trial where available
    SPN vs PPN in preterm infants
    SPN vs PPN in preterm infants
    A.4.1Sponsor's protocol code numberSP-PP18
    A.5.4Other Identifiers
    Name:clinicaltrials.govNumber:NCT03693287
    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 SponsorAZIENDA OSPEDALIERO-UNIVERSITARIA OSPEDALI RIUNITI DI ANCONA
    B.1.3.4CountryItaly
    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 supportAOU ospedali riuniti di ancona
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportazienda ospedaliera di Padova
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportHOSPITAL UNIVERSITARIO LA PAZ
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportBaxter SpA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNIVERSITA' POLITECNICA DELLE MARCHE
    B.5.2Functional name of contact pointSEGRETERIA SOD NEONATOLOGIA
    B.5.3 Address:
    B.5.3.1Street AddressVIA ENRICO TOTI 4
    B.5.3.2Town/ cityANCONA
    B.5.3.3Post code60123
    B.5.3.4CountryItaly
    B.5.4Telephone number0390715962045
    B.5.6E-mailV.CARNIELLI@UNIVPM.IT
    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 NUMETA - G13%E EMULSIONE PER INFUSIONE 10 SACCHE DA 300 ML A 3 CAMERE NON PVC
    D.2.1.1.2Name of the Marketing Authorisation holderBAXTER S.P.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameNUMETA G13%E
    D.3.2Product code [FDB9601]
    D.3.4Pharmaceutical form Emulsion for infusion
    D.3.4.1Specific paediatric formulation Yes
    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 INNGLUCOSIO
    D.3.9.2Current sponsor codeIVGLU
    D.3.9.3Other descriptive nameglucose solution
    D.3.9.4EV Substance CodeSUB13981MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMULSIONE LIPIDICA PER NUTRIZIONE PARENTERALE
    D.3.9.2Current sponsor codeIVCLI
    D.3.9.3Other descriptive nameFat emulsion containing olive and soy lipids.
    D.3.9.4EV Substance CodeSUB73474
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMINOACIDI SOLUZIONI
    D.3.9.2Current sponsor codeIVPRI
    D.3.9.3Other descriptive nameAmino acid solution containing: glycine, threonine, tryptophan, methionine, lysine, taurine, alanine, arginine, aspartic acid, cysteine, glutamic acid, histidine, isoleucine, leucine, ornithine, phenylalanine, proline, serine, tyrosine, valine.
    D.3.9.4EV Substance CodeSUB23205
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number59
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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.IMP: 2
    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 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 nameSACCA PARENTERALE PERSONALIZZATA
    D.3.2Product code [PPN]
    D.3.4Pharmaceutical form Emulsion for infusion
    D.3.4.1Specific paediatric formulation Yes
    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 INNGLUCOSIO
    D.3.9.2Current sponsor codeIVGLU
    D.3.9.3Other descriptive nameglucose solution
    D.3.9.4EV Substance CodeSUB13981MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAMINOACIDI SOLUZIONI
    D.3.9.2Current sponsor codeIVPRI
    D.3.9.3Other descriptive nameAmino acid solution containing: glycine, threonine, tryptophan, methionine, lysine, taurine, alanine, arginine, aspartic acid, cysteine, glutamic acid, histidine, isoleucine, leucine, ornithine, phenylalanine, proline, serine, tyrosine, valine.
    D.3.9.4EV Substance CodeSUB23205
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMULSIONE LIPIDICA PER NUTRIZIONE PARENTERALE
    D.3.9.2Current sponsor codeIVCLI
    D.3.9.3Other descriptive nameFat emulsion containing olive and soy lipids
    D.3.9.4EV Substance CodeSUB73474
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Growth of preterm infants in case of reduced or absent enteral nutrition due to gastrointestinal intolerance or to an early or late disease.
    Crescita del neonato pretermine in caso di nutrizione enterale ridotta o assente per intolleranza gastrointestinale o per malattia precoce o tardiva.
    E.1.1.1Medical condition in easily understood language
    Growth of preterm infants in case of reduced or no food intake through the gut due to gastrointestinal intolerance or to an early or late disease.
    Crescita del neonato prematuro in caso di ridotta o assente assunzione di cibo attraverso l'intestino per intolleranza gastrointestinale oppure per malattia precoce o tardiva.
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10051284
    E.1.2Term Parenteral nutrition
    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
    To assess the growth of preterm infants with a birth weight (BW) greater than 1250 grams who randomly received personalized PN (P-PN) or standardized PN (S-PN).
    Valutare la crescita ponderale durante il periodo di nutrizione parenterale (PN), in neonati pretermine (età gestazionale<37 settimane) con peso neonatale maggiore di 1250 grammi randomizzati a ricevere una PN con sacca personalizzata (P-PN) o standard (S-PN).
    E.2.2Secondary objectives of the trial
    To compare:
    1- metabolic tolerance (glucose, amino acids, lipids) during PN,
    2- electrolyte and acid-base balance during PN,
    3- anthropometric parameters up to 42 weeks of gestation or discharge if it occurs first,
    4- bone mineralization and body growth from the admission to one month of life,
    5- liver function during the first weeks of life,
    6- diseases associated with prematurity from the admission to 42 weeks of gestation or discharge if it occurs first,
    7- therapies from the admission to 42 weeks of gestation or discharge if it occurs first,
    8- the cost of care (euro) during PN and from the admission to 42 weeks of gestation or discharge if it occurs first.
    Confrontare:
    1- la tolleranza metabolica (glucidica, proteica e lipidica) in corso di PN,
    2- l’equilibrio elettrolitico ed acido-base in corso di PN,
    3- la crescita antropometrica fino al compimento della 42° settimana di età gestazionale o alla dimissione se precedente,
    4- la mineralizzazione ossea e crescita corporea dal ricovero ad un mese di vita,
    5- la funzionalità epatica nelle prime settimane di vita,
    6- l’incidenza di patologie legate alla prematurità dal ricovero al compimento della 42° settimana di età gestazionale o alla dimissione se precedente,
    7- l’entità delle terapie somministrate dal ricovero al compimento della 42° settimana di età gestazionale o alla dimissione se precedente,
    8- il costo delle cure (euro) durante il periodo di PN e dal ricovero al compimento della 42° settimana di età gestazionale o alla dimissione se precedente
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Birth weight > 1250 grams,
    - Gestational age at birth between 27.0 and 36.6 weeks,
    - need of parenteral nutrition,
    - informed consent.
    - peso alla nascita maggiore di 1250 grammi,
    - età gestazionale alla nascita compresa tra 27.0 e 36.6 settimane,
    - necessità di nutrizione parenterale,
    - consenso informato dei genitori o del legale rappresentante.
    E.4Principal exclusion criteria
    - genetic, metabolic or endocrine disorders before/after enrolment;
    - drug therapy with ceftriaxone or cumarina before/after enrolment;
    - drug therapy with calcium before enrolment;
    - cholestasis or hepatic insufficiency before enrolment;
    - renal insufficiency before enrolment;
    - hyponatremia before enrolment;
    - hyperlipidemia/hypertriglyceridemia before enrolment;
    - any hypersensitivity to the compounds of the study parenteral bags before/after enrolment;
    - drug therapy with off-label drugs before/after enrolment;
    - lacking informed consent.
    - disordini genetici, metabolici o endocrini diagnosticati prima dell'arruolamento;
    - terapia con ceftriaxone o cumarina prima/dopo l’arruolamento;
    - terapia con calcio prima dell’arruolamento;
    - colestasi o insufficienza epatica accertata prima dell’arruolamento;
    - insufficienza renale prima dell’arruolamento;
    - iponatriemia prima dell’arruolamento;
    - iperlipidemia/ipertrigliceridemia prima dell’arruolamento;
    - ipersensibilità nota o accertata ad uno qualsiasi dei componenti delle sacche parenterali in studio prima/dopo l’arruolamento;
    - terapia con farmaci off-label prima/dopo l’arruolamento;
    - assenza del consenso allo studio da parte dei genitori o legale rappresentante prima/dopo l’arruolamento.
    E.5 End points
    E.5.1Primary end point(s)
    WEIGHT CHANGE: Daily weight change (g/kg/d) during parenteral nutrition (PN).
    Velocità di crescita ponderale (g/kg/giorno) durante il periodo di nutrizione parenterale.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From the start to the stop of PN (endpoint: PN day 28 if PN duration >28 days). At least 7 days of PN will be required to calculate weight gain during PN.
    Dall'inizio della nutrizione parenterale (NP) allo stop di NP (end point: giorno 28 di NP per NP di durata superiore ai 28 giorni). Almeno 7 giorni di NP saranno richiesti per il calcolo della velocità di crescita ponderale.
    E.5.2Secondary end point(s)
    Episodes of HYPER and HYPO-NATREMIA/-KALIEMIA/-CHLOREMIA/-CALCEMIA/ -PHOSPHATEMIA/-PARATHYROIDISM, METABOLIC ACIDOSIS, CHOLESTASIS, HEPATIC AND RENAL INSUFFICIENCY: Hyper/Hypo Natremia (number) and Hyper/Hypo Kaliemia (number).; BONE MINERALIZATION: Plasma calcium and phosphorus (mg/dl), ALP, AST, ALT, gammaGT (UI/L), parathormone (PTH; pg/ml), and urinary calcium and phosphorus (mg/dl).; BONE MINERALIZATION: PYD, PICP and ICTP CONCENTRATION (optional) : Urinary pyridinoline crosslinks of collagen (Pyd; nmol/L), serum carboxyterminal propeptide of type I procollagen (PICP; ng/mL) and serum crosslinked carboxyterminal telopeptide of type I collagen (ICTP; ng/mL).; BILIRUBIN CONCENTRATION : Plasma bilirubin (total and conjugated; mg/dl).; DISEASES: Incidence of the main complication of prematurity (intraventricular hemorrhage of 3° and 4° grade; Periventricular leukomalacia; Patent ductus arteriosus; Retinopathy of prematurity, Bronchopulmonary dysplasia; Sepsis).; THERAPIES: duration of PN (days), enteral feeding and parenteral (ml/kg), mechanical ventilation (days), oxygen and drug therapy (days).; PHARMACOECONOMICS : Healthcare costs (euro).; ADVERSE EVENTS and METABOLIC COMPLICATIONS: number of death and of hypertriglyceridemia, hyperglycaemia, hypoglycaemia, and elevated urea episodes.; ADIPOSE TISSUE ULTRASOUND (optional): Ultrasound measurement of mid thigh and mid arm adipose tissue thickness (cm).; BONE ULTRASOUND (optional): Metacarpus speed of sound (m/s) and metacarpus bone transmission time (ms); WEIGHT: Weight measured by a digital infant scale (grams).; TOTAL BODY LENGTH : Total body length measured by a neonatal stadiometer (cm).; HEAD CIRCUMFERENCE : Head circumference measured by a flexible non-stretchable tape (cm).; GLUCIDE TOLERANCE: Blood glycemia (mg/dl).; AMINO ACID TOLERANCE : Plasma and urinary urea concentrations (mg/dl).; TRIGLYCERIDE CONCENTRATION : Plasma triglycerides (TG; mg/dl).; FATTY ACID CONCENTRATION (optional) : Plasma fatty acid concentration (FA; mg/dl).; DICARBOXYLIC AND HYDROXYL FATTY ACID CONCENTRATION (optional): Urinary dicarboxylic acids (DCA; mmol/mol creatinine) and hydroxyl fatty acids (H-FA; mmol/mol creatinine).; ELECTROLYTE CONCENTRATION (Na+, mmol/l; K+, mmol/l; Ca2+, mg/dl; Cl-, mmol/l) and ACID-BASE HOMEOSTASIS (SBE, mmol/l);
    MUSCLE ULTRASOUND (optional): Ultrasound measurement of mid thigh and mid arm muscle thickness (cm).; ecografia muscolare (facoltativo): Spessore, in cm, del muscolo della coscia e del braccio; Episodi di ipo/iper-natriemia, ipo/iper-kaliemia, ipo/iper-cloremia, ipo/iper-calcemia, ipo/iper-fosfatemia ipo/iper-paratiroidismo, acidosi metabolica, colestasi, insufficienza epatica e renale; mineralizzazione ossea 1: Calcio e fosforo (mg/dL), fosfatasi alcalina (UI/L), aspartato transaminasi (UI/L), alanina aminotransferasi (UI/L), gamma glutamiltranspeptidasi (UI/L) e paratormone (pg/mL) plasmatici, e calcio e fosforo urinari (mg/dL); mineralizzazione ossea 2 (facoltativo): Piridinoline urinarie (Pyr, nmol/L), propeptide carbossi-terminale del procollagene di tipo I (PICP, ng/mL) e telopeptide carbossi-terminale del collagene di tipo I (ICTP, ng/mL) sierici; Bilirubina plasmatica (totale e coniugata) in mg/dL; malattie: Incidenza di emorragia intra-ventricolare di grado 3 e 4, leucomalacia periventricolare, trattamento e legatura chirurgica del dotto di Botallo pervio, broncodisplasia polmonare, retinopatia del prematuro, e sepsi; terapie: durata della NP (giorni), nutrizione enterale e parenterale (ml/kg), ventilazione meccanica (giorni), terapie farmacologiche e ossigeno (giorni); costo delle cure (euro); eventi avversi e complicanze metaboliche: numero di morti ed episodi di ipertrigliceridemia, iperglicemia, ipoglicemia ed elevata urea; ecografia del tessuto adiposo (facoltativo): Spessore, in cm, del tessuto adiposo della coscia e del braccio; ecografia dell'osso (facoltativo): Velocità, in m/s, e tempo, in ms, di trasmissione del suono del metacarpo; Peso corporeo, in grammi, misurato con bilancia elettronica; Lunghezza corporea, in cm, misurato con uno stadiometro flessibile; Circonferenza cranica, in cm, misurato con uno nastro graduato flessibile; Glicemia in mg/dL; Urea plasmatica e urinaria in mg/dL; Trigliceridi plasmatici in mg/dL; Acidi grassi plasmatici in mg/dL; Acidi dicarbossilici e idrossiacidi urinari in mmol/mol di creatinina; Elettroliti ematici (Na+, mmol/L; K+, mmol/L; Ca2+, mg/dL; Cl-, mmol/L) ed eccesso base standard (SBE, mmol/L)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the start of PN, after 7, 14 and 28 days from the start of PN.; Daily from the start to the stop of PN.; At the start of PN and at PN day 7 and at PN 28 in patients requiring long term PN.; At the start of PN and at PN day 28.; At PN day 7. An additional measurement will be performed at PN day 14 in case of PN duration >14 days.; Daily up to 42 weeks post menstrual age or discharge if it occurred before; Daily up to 42 weeks post menstrual age or discharge if it occurred before; Daily up to 42 weeks post menstrual age or discharge if it occurred before; Daily up to 42 weeks post menstrual age or discharge if it occurred before; At the start of PN, after 7, 14 and 28 days from the start of PN.; At the start of PN, after 7, 14 and 28 days from the start of PN.; Daily up to 42 weeks post m
    all'inizio della nutrizione parenterale (NP), dopo 7, 14 e 28 giorni dall'inizio di NP.; giornalmente dall'inizio alla fine della NP; all'inizio della NP e al giorno 7 di NP e 28 di NP in pazienti che richiedono una NP più lunga; all'inizio di NP e al giorno 28 di NP.; al giorno 7 di NP. Misure aggiuntive potranno essere eseguite al giorno 14 in caso di NP >14 giorni; giornalmente fino alla 42-esima di età post-mestruale o dimissione se precedente; giornalmente fino alla 42-esima di età post-mestruale o dimissione se precedente; giornalmente fino alla 42-esima di età post-mestruale o dimissione se precedente; giornalmente fino alla 42-esima di età post-mestruale o dimissione se precedente; All'inizio della nutrizione parenterale (NP), dopo 7, 14 e 28 giorni dall'inizio di NP.; All'inizio d
    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 No
    E.6.4Safety No
    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) 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 Yes
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 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
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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.1.1.2.1Number of subjects for this age range: 150
    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
    Newborns will be studied. Written informed consent will be obtained from the parents or legal guardians ofeach infants before the enrollement.
    Verrà richiesta la firma del consenso informato per la partecipazione allo studio da parte del neonato ai genitori o al legale rappresentante prima dell'arruolamento.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 150
    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
    nessuno
    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 Decision2019-12-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-12
    P. End of Trial
    P.End of Trial StatusOngoing
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