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    Summary
    EudraCT Number:2018-003626-91
    Sponsor's Protocol Code Number:CAFSP01
    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:2020-11-04
    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 number2018-003626-91
    A.3Full title of the trial
    CAFFEINE TREATMENT IN DELIVERY ROOM FOR VERY PRETERM INFANTS : A FEASIBILITY STUDY
    TRATTAMENTO DEL NEONATO MOLTO PRETERMINE CON CAFFEINA IN SALA PARTO: STUDIO DI FATTIBILITA’
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CAFFEINE TREATMENT IN DELIVERY ROOM FOR VERY PRETERM INFANTS : A FEASIBILITY STUDY
    TRATTAMENTO DEL NEONATO MOLTO PRETERMINE CON CAFFEINA IN SALA PARTO: STUDIO DI FATTIBILITA’
    A.3.2Name or abbreviated title of the trial where available
    CAFFEINE IN DELIVERY ROOM
    CAFFEINA IN SALA PARTO
    A.4.1Sponsor's protocol code numberCAFSP01
    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 CAREGGI
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAZIENDA OSPEDALIERO-UNIVERSITARIA CAREGGI
    B.5.2Functional name of contact pointNEONATOLOGIA E TERAPIA INTENSIVA NE
    B.5.3 Address:
    B.5.3.1Street AddressLARGO BRAMBILLA 3
    B.5.3.2Town/ cityFIRENZE
    B.5.3.3Post code50134
    B.5.3.4CountryItaly
    B.5.4Telephone number05579478421
    B.5.5Fax number0557947326
    B.5.6E-mailcarlo.dani@unifi.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 PEYONA - 20MG/ML - SOLUZIONE PER INFUSIONE E SOLUZIONE ORALE - PER SOMMINISTRAZIONE ENDOVENOSA E ORALE - FLACONCINO(VETRO) 10 FLACONCINI DA 3 ML
    D.2.1.1.2Name of the Marketing Authorisation holderCHIESI FARMACEUTICI 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/03/132
    D.3 Description of the IMP
    D.3.1Product namePeyona
    D.3.2Product code [40889014]
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPEnteral use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcaffeine citrate
    D.3.9.2Current sponsor code040889
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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
    25+0-29+6 gestational age preterm infants at risk of respiratory distress syndrome with no need of mechanical ventilation in delivery room.
    Neonati di età gestazionale pari a 25+0-29+6 settimane ad alto rischio di sviluppare “respiratory distress syndrome” (RDS) che non richiedano ventilazione meccanica in sala parto.
    E.1.1.1Medical condition in easily understood language
    25+0-29+6 gestational age preterm infants with no need of mechanical ventilation in delivery room.
    Neonati di età gestazionale pari a 25+0-29+6 settimane ad alto rischio di insufficienza respiratoria che non richiedano ventilazione meccanica in sala parto.
    E.1.1.2Therapeutic area Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10021734
    E.1.2Term Infant premature
    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 feasibility of the administration of intravenous or enteral caffeine in delivery room.
    Il presente studio di fattibilità ha lo scopo di verificare l’ipotesi che sia possibile somministrare la caffeina in sala parto per via endovenosa e per via enterale attraverso una sonda orogastrica. Tale studio è preliminare alla pianificazione di un successivo studio controllato randomizzato di dimensioni adeguate, che avrà lo scopo di valutare se la caffeina somministrata così precocemente possa effettivamente ridurre il rischio di VM nei neonati pretermine. Obiettivo primario, quindi, sarà la valutazione della fattibilità operativa della somministrazione della caffeina per via endovenosa o enterale nel neonato molto pretermine in sala parto durante l’assistenza per la stabilizzazione cardiorespiratoria del neonato.
    E.2.2Secondary objectives of the trial
    Comparison of intravenous administration vs enteral administration
    Evaluation of need of mechanical ventilation in treated newborn
    Obiettivi secondari saranno il confronto della fattibilità della somministrazione della caffeina per via endovenosa vs. enterale e la valutazione del fabbisogno di ventilazione meccanica nei neonati trattati.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. 25+0-29+6 gestational age preterm infants with no need of mechanical ventilation in delivery room.
    2. parental informed consent
    1. Neonati “inborn” di età gestazionale pari a 25+0-29+6 settimane ad alto rischio di sviluppare “respiratory distress syndrome” (RDS) che non richiedano ventilazione meccanica in sala parto.
    2. Consenso informato dei genitori
    E.4Principal exclusion criteria
    1. Neonates born from mothers that assumed high quantity of caffeine (more than 2 cups of coffee in 6 hours before the delivery)
    2. Major congenital malformation, cromosomal syndrome, Inborn errors of the metabolism
    3. Hydrops fetalis
    1. nati da madri che abbiano assunto elevate quantità di caffeina prima del parto (>2 tazzine di caffè nelle 6 ore antecedenti il parto),
    2. malformazioni congenite maggiori, sindromi cromosomiche, e difetti congeniti del metabolismo,
    3. idrope fetale
    E.5 End points
    E.5.1Primary end point(s)
    Numbers of neonates that successfully received intravenous or enteral caffeine in the first 10 minutes of life.
    L’ endpoint primario sarà costituito dalla valutazione del numero dei neonati in cui la somministrazione della caffeina per via endovenosa o enterale in sala parto è avvenuta con successo entro 10 minuti dalla nascita.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 mesi
    E.5.2Secondary end point(s)
    Number of succesful achievement of therapeutic range at the second dosage (before the second caffeine administration); Number of succesful caffeine administration in the delivery room, defined as therapy administration in the expected time;; Number of successful achievement of therapeutic range at the first dosage; Comparison between caffein blood level in enteral caffeine administration vs intravenous caffeine administration; Need of mechanical ventilation in the first 72 hours of live of the treated neonates
    Frequenza di successi nel raggiungimento del range terapeutico nel secondo dosaggio (caffeinemia pre-dose); numero dei neonati in cui la somministrazione della caffeina è avvenuta con successo per via endovenosa versus via enterale.; numero dei neonati in cui la somministrazione della caffeina è avvenuta con successo che hanno raggiunto il range terapeutico di concentrazione plasmatica dopo la prima dose, a conferma del buon esito della somministrazione;; Confronto tra la caffeinemia ottenuta con la somministrazione endovenosa ed enterale.; Frequenza di ventilazione meccanica entro le prime 72 ore di vita nei neonati studiati.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months; 12 months; 12 months; 12 months; 12 months
    12 mesi; 12 mesi; 12 mesi; 12 mesi; 12 mesi
    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 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 Yes
    E.6.13.1Other scope of the trial description
    feasibility study
    studio di fattibilità
    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 Yes
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Stesso farmaco con diversa via di somministrazione
    Same drug with different route of administration
    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.8.4.1Number of sites anticipated in Member State concerned1
    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 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
    The conclusion of the study is defined as the end of the observation for the last enrolled patient.
    La conclusione dello studio è definita come la fine dell’osservazione per l’ultimo paziente arruolato.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months0
    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: 40
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 40
    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
    Parental consent
    neonati pretermine con consenso da parte dei genitori
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Routinary follow-up for preterm infants in Neonatology departement
    Follow-up previsto dal centro per i neonati prematuri
    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 Decision2019-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-09
    P. End of Trial
    P.End of Trial StatusOngoing
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