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    Summary
    EudraCT Number:2016-004198-41
    Sponsor's Protocol Code Number:UCDCRC/16/003
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-30
    Trial results View 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 ConcernedCzechia - SUKL
    A.2EudraCT number2016-004198-41
    A.3Full title of the trial
    PROPHYLACTIC OROPHARYNGEAL SURFACTANT FOR PRETERM INFANTS: A RANDOMISED TRIAL (THE POPART TRIAL)
    Profylaktický orofaryngeální surfaktant pro předčasně narozené novorozence: randomizované klinické hodnocení (HODNOCENÍ POPART)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To investigate the use of surfactant in preterm babies as a preventative measure against intubation in the windpipe.
    Prozkoumat použití surfaktantu u předčasně narozených dětí jako preventivní opatření proti intubaci v průdušnici.
    A.3.2Name or abbreviated title of the trial where available
    POPART
    A.4.1Sponsor's protocol code numberUCDCRC/16/003
    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 SponsorUniversity College Dublin
    B.1.3.4CountryIreland
    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 Limited
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity College Dublin
    B.5.2Functional name of contact pointQuality & Regulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressCatherine McAuley Centre, MMUH
    B.5.3.2Town/ cityNelson Street
    B.5.3.3Post codeDublin 7
    B.5.3.4CountryIreland
    B.5.4Telephone number0035317164593
    B.5.6E-mailrabia.hussain@ucd.ie
    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 Limited
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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 nameCUROSURF®
    D.3.4Pharmaceutical form Endotracheopulmonary instillation, suspension
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPOropharyngeal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPoractant Alfa
    D.3.9.1CAS number 129069-19-8
    D.3.9.3Other descriptive namePORACTANT ALFA
    D.3.9.4EV Substance CodeSUB22150
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number120 to 240
    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 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 Yes
    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 at risk of respiratory distress syndrome
    E.1.1.1Medical condition in easily understood language
    Premature babies at risk of respiratory distress syndrome
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10054933
    E.1.2Term Neonatal respiratory distress syndrome prophylaxis
    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
    Our primary objective is to investigate the efficacy of prophylactic oropharyngeal surfactant for reducing the rate of endotracheal intubation, compared to no intervention in infants at risk of RDS.
    E.2.2Secondary objectives of the trial
    To investigate the efficacy of prophylactic oropharyngeal surfactant compared to no intervention for preventing some possible complications in premature infants at risk of RDS, we will also record a number of variables relating to prematurity, from enrolment into the trial until discharge home from hospital.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • born at a participating centres with a gestational age at birth < 29 weeks (i.e. up to 28+6 days gestation) by best obstetric estimate; and
    • the treating doctors plan to offer them intensive care
    E.4Principal exclusion criteria
    - Infants with major congenital anomalies including neural tube defects, major structural cardiac anomalies (excluding PDA/ASD/VSD), abdominal wall defects and congenital diaphragmatic hernia and major dysmorphic features with an abnormal karyotype e.g. T21, T13, T18
    - The treating clinician does not intend to offer the infant intensive care.
    - Written informed consent has not been obtained prior to delivery or subjects’ parent(s)/guardian(s) withdraws consent following enrolment.
    E.5 End points
    E.5.1Primary end point(s)
    The incidence of endotracheal intubation for respiratory failure within 120 hours of birth. Enrolled infants will be intubated for persistent apnoea and/or bradycardia in the DR, or for respiratory failure in the NICU defined as ≥ 2 of:
    • Clinical signs – worsening tachypnoea; grunting; subcostal, intercostal and/or sternal recession
    • Acidosis – pH < 7.2 on 2 blood gases (arterial or capillary) ≥ 30 minutes apart
    • O2 – FiO2 > 0.4 to keep SpO2 ≥ 90% for > 30 minutes
    • PCO2 > 9.0 kPa on 2 blood gases (arterial or capillary) ≥ 30 minutes apart
    • Apnoea – recurrent apnoea treated with mask ventilation
    E.5.1.1Timepoint(s) of evaluation of this end point
    120 hours after birth
    E.5.2Secondary end point(s)
    1. Number of attempts taken to successfully intubate in the DR
    2. Chest compressions in the DR
    3. Adrenaline administration in the DR
    4. Rectal temperature on admission to the NICU
    5. NICU intubation
    6. Surfactant use before death or hospital discharge
    7. Number of doses, including total dose
    8. Intra-tracheal surfactant received post-intervention
    9. Doses of post-intervention surfactant
    10. Respiratory distress syndrome
    o Clinical evidence of respiratory distress with radiological evidence (ground glass appearance on CXR)
    11. Incidence of pneumothorax
    o Incidence of pneumothorax on CXR
    12. Incidence of pulmonary haemorrhage
    o Clinical evidence of pulmonary haemorrhage
    13. Mechanical ventilation
    14. Days of mechanical ventilation
    15. Use of postnatal corticosteroids for ventilator dependence
    16. Days of duration of respiratory support (endotracheal ventilation, high-frequency oscillatory ventilation, CPAP, heated humidified high-flow nasal cannula O2 ,low flow nasal cannula O2)
    17. Bronchopulmonary dysplasia (BPD) –supplemental O2 at 28 days of life
    18. Chronic lung disease of prematurity (CLD) – need for supplemental O2 at 36 weeks corrected gestational age (CGA) determined by physiological oxygen reduction test
    19. Medical treatment for a patent ductus arteriosus
    o Administration of ibuprofen or paracetemol for PDA
    20 Surgical treatment for a patent ductus arteriosus
    21. Proven necrotising enterocolitis (≥ Bell’s stage 2)
    22. Incidence of Intraventricular haemorrhage (IVH) (any and severe: IVH grade ≥ 3)
    o Evidence on surveillance cranial ultrasounds performed regularly in NICU as standard of care
    23. Incidence of cystic periventricular leukomalacia
    o Evidence on surveillance cranial ultrasounds performed regularly in NICU as standard of care
    24. Retinopathy of prematurity treated with laser photocoagulation or intravitreal injections
    o Evidence on surveillance ophthalmology review performed regularly in NICU as standard of care
    25. Death before hospital discharge
    26. Survival without BPD at hospital discharge
    27. Survival without CLD at hospital discharge
    28. Duration of hospitalisation
    29. Use of home oxygen therapy
    o Discharged home on oxygen therapy
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Endpoints 1-5 will be measured between day 0 - 120 hours of life.

    Secondary Endpoint 17, Bronchopulmonary dysplasia will be assessed at 28 days of life.

    Secondary Endpoint 18, Chronic lung disease prematurity, will be assessed at 36 weeks corrected gestational age.

    All remaining secondary endpoints to be assessed at discharge home.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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
    Continuous positive airway pressure (CPAP) as per routine practice
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA12
    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 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
    LVLS (discharge of patient)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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.1.1Number of subjects for this age range: 250
    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: 250
    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 No
    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
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 250
    F.4.2.2In the whole clinical trial 250
    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)
    N/A
    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 Decision2018-11-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-11-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-01-18
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