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    Summary
    EudraCT Number:2019-004720-38
    Sponsor's Protocol Code Number:LATE-REC-SURF
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-10-21
    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 number2019-004720-38
    A.3Full title of the trial
    Effects of late surfactant treatment delivered after a recruitment maneuver on respiratory outcomes in extremely low gestational age newborns: a randomized controlled trial – LATE-REC-SURF Trial.
    Effetti di un trattamento tardivo con surfattante preceduto da una manovra di reclutamento sugli outcome respiratori di neonati estremamente prematuri: trial randomizzato controllato - LATE-REC-SURF Trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effects of late surfactant treatment delivered after a recruitment maneuver on respiratory outcomes in extremely low gestational age newborns: a randomized controlled trial – LATE-REC-SURF Trial.
    Effetti di un trattamento tardivo con surfattante preceduto da una manovra di reclutamento sugli outcome respiratori di neonati estremamente prematuri: trial randomizzato controllato - LATE-REC-SURF Trial.
    A.3.2Name or abbreviated title of the trial where available
    LATE-REC-SURF
    LATE-REC-SURF
    A.4.1Sponsor's protocol code numberLATE-REC-SURF
    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 SponsorFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    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 supportChiesi Farmaceutici S.p.A
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE POLICLINICO UNIVERSITARIO A. GEMELLI IRCCS
    B.5.2Functional name of contact pointDIREZIONE SCIENTIFICA
    B.5.3 Address:
    B.5.3.1Street AddressLARGO A GEMELLI 8
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00135
    B.5.3.4CountryItaly
    B.5.4Telephone number0630155701
    B.5.5Fax number0630155701
    B.5.6E-maildirezione.scientifica@poiliclinicogemelli.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 CUROSURF
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Farmaceutici S.p.a.
    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 namePORACTANT
    D.3.2Product code [R07AA02]
    D.3.4Pharmaceutical form Endotracheopulmonary instillation, suspension
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPEndotracheopulmonary use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFRAZIONE FOSFOLIPIDICA DA POLMONE SUINO
    D.3.9.1CAS number 129069-19-8
    D.3.9.2Current sponsor code129069-19-8
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number200
    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
    Preterm infants still requiring mechanical ventilation at 7-10 days of life.
    Neonati pretermine che richiedono ancora una ventilazione meccanica a 7-10 giorni di vita.
    E.1.1.1Medical condition in easily understood language
    Preterm infants still requiring mechanical ventilation at 7-10 days of life.
    Neonati pretermine che richiedono ancora una ventilazione meccanica a 7-10 giorni di vita.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10076729
    E.1.2Term Very preterm infant
    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 test the hypothesis that endotracheal administration of poractant alfa preceded by a recruitment manoeuvre in High-Frequency Oscillatory Ventilation (HFOV) modality in preterm infants still requiring mechanical ventilation at 7-10 days of life could reduce the length of invasive mechanical ventilation.
    Verificare l'ipotesi che la somministrazione endotracheale di poractant-alfa preceduta da una manovra di reclutamento in modalità di ventilazione oscillatoria ad alta frequenza (HFOV) in neonati pretermine che richiedono ancora una ventilazione meccanica a 7-10 giorni di vita riduca la durata della ventilazione meccanica invasiva.
    E.2.2Secondary objectives of the trial
    Key secondary objective:
    To test the hypothesis that endotracheal administration of poractant alfa preceded by a recruitment manoeuvre in High-Frequency Oscillatory Ventilation (HFOV) modality in preterm infants still requiring mechanical ventilation at 7-10 days of life could reduce the rate of bronchopulmonary dysplasia.
    Obiettivo secondario principale:
    Verificare l'ipotesi che la somministrazione endotracheale di poractant-alfa preceduta da una manovra di reclutamento in modalità di ventilazione oscillatoria ad alta frequenza (HFOV) in neonati pretermine che richiedono ancora una ventilazione meccanica a 7-10 giorni di vita riduca l’incidenza di displasia broncopolmonare.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Extremely low gestational age newborn infants (GA < 28 weeks) – gestational age matching between maternal dates and/or early antenatal ultrasound
    2. Singleton or multiple birth
    3. Postnatal age between 7 and 10 days
    4. Invasive mechanical ventilation still needed
    5. Fraction of inspired oxygen (FiO2) of more than 0.30 and/or an oxygenation index of 8 or more for at least 6 hours
    6. Stable cardiovascular condition
    7. Informed consent form signed by parents or legal guardian
    1. Neonati di età gestazionale estremamente bassa - ELGANS (EG < 28 settimane) calcolata sulla base dell’ultima mestruazione e/o ecografia prenatale del primo trimestre
    2. Nascite single o multiple
    3. Età postnatale compresa tra il 7° ed il 10° giorno
    4. Necessità di ventilazione meccanica invasiva
    5. Frazione di ossigeno inspirato (FiO2) superiore a 0.30 e/o un oxygenation index pari a 8 o superiore per 6 ore consecutive
    6. Conditioni cardiovascolari stabili
    7. Consenso informato firmato dai genitori o rappresentanti legali del bambino
    E.4Principal exclusion criteria
    1. Major congenital malformation (i.e., infants with genetic, metabolic or endocrine disorder diagnosed before enrolment)
    2. High index of suspicion of infection before enrolment
    3. Neurological conditions that might contraindicate extubation
    4. Inotropic agents needed
    5. Pneumothorax
    6. Hemodynamically significant ductus arteriosus
    7. Surgical intervention within the past 72 hours
    8. Partecipation in another interventional clinical study that may interfere with the results of this trial
    1. Malformazioni congenite maggiori (ad esempio, i bambini con disturbo genetico, metabolico o endocrino diagnosticato prima dell'arruolamento)
    2. Forte sospetto di infezione
    3. Condizioni neurologiche che potrebbero controindicare l'estubazione
    4. Necessità di agenti inotropi
    5. Pneumotorace
    6. Dotto arterioso emodinamicamente pervio
    7. Intervento chirurgico nelle precedent 72 ore
    8. Partecipazione ad un altro studio clinic interventistico che possa interferire con I risultati di questo trial
    E.5 End points
    E.5.1Primary end point(s)
    First successful extubation (day of life) defined as extubation not followed by a reintubation for at least 7 days.
    Prima estubazione di successo (giorno di vita) definita come estubazione che non è stata seguita da reintubazione per i successivi 7 giorni
    E.5.1.1Timepoint(s) of evaluation of this end point
    Extubation will be considered successful when adequate spontaneous respiration will be maintained for at least 7 days.
    L'estubazione sarà considerata efficace quando verrà mantenuta un'adeguata respirazione spontanea nei successivi 7 giorni.
    E.5.2Secondary end point(s)
    Key secondary end-point:
    Rate of bronchopulmonary dysplasia expressed as the oxygen-dependance at 36 weeks of post-menstrual age.
    End-point secondario principale:
    Incidenza di broncodisplasia definite come ossigenodipendenza a 36 settimane di età post-mestruale.
    E.5.2.1Timepoint(s) of evaluation of this end point
    From birth to discharge.
    Dalla nascita pretermine fino alla dimissione.
    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) 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
    ventilazione meccanica secondo pratica clinica
    mechanical ventilation according to clinical practice
    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
    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 months0
    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 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: 20
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    PRETERM NEWBORNS
    NEONATI PRETERMINE
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 20
    F.4.2.2In the whole clinical trial 20
    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)
    The infants will be monitored until discharge and will return to clinical site for a follow-up visit at 12 months corrected age.
    I bambini saranno monitorati fino alla dimissione e torneranno per una visita di follow-up all'età corretta di 12 mesi.
    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 Decision2020-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2024-07-31
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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