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Clinical trials for Poractant alfa

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44341   clinical trials with a EudraCT protocol, of which   7370   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    15 result(s) found for: Poractant alfa. Displaying page 1 of 1.
    EudraCT Number: 2020-002632-75 Sponsor Protocol Number: CLI-050000-04 Start Date*: 2020-07-08
    Sponsor Name:CHIESI FARMACEUTICI S.p.A
    Full Title: Multicenter, open-label, randomised trial to assess the efficacy and tolerability of poractant alfa (porcine surfactant, Curosurf®) in hospitalized patients with SARS-COV-19 acute respiratory distr...
    Medical condition: patients with SARS-COV-19 acute respiratory distress syndrome (ARDS)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-004720-38 Sponsor Protocol Number: LATE-REC-SURF Start Date*: 2020-12-21
    Sponsor Name:FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    Full Title: 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.
    Medical condition: Preterm infants still requiring mechanical ventilation at 7-10 days of life.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004868 10076729 Very preterm infant LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-001974-14 Sponsor Protocol Number: CCD-050000-01 Start Date*: 2023-08-11
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: An Open-Label, Multicenter, Randomized, Controlled Study in Spontaneously Breathing Preterm Neonates with Respiratory Distress Syndrome to Compare Two Procedures for Porcine Surfactant (poractant a...
    Medical condition: Treatment of Respiratory Distress Syndrome (RDS) in spontaneously breathing preterm neonates.
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2016-004547-36 Sponsor Protocol Number: CCD-01534CA1-01 Start Date*: 2017-03-16
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: A RANDOMIZED, OPEN, MULTINATIONAL, MULTICENTRE, 2-PART STUDY IN SPONTANEOUSLY BREATHING PRETERM NEONATES WITH MILD TO MODERATE RESPIRATORY DISTRESS SYNDROME TO INVESTIGATE THE SAFETY, TOLERABILITY ...
    Medical condition: Mild to moderate respiratory distress syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004855 10038690 Respiratory distress syndrome (neonatal) LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) CZ (Prematurely Ended) GB (Prematurely Ended) AT (Prematurely Ended) FR (Prematurely Ended) PL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-006912-31 Sponsor Protocol Number: AMV-12_12_2006 Start Date*: Information not available in EudraCT
    Sponsor Name:Universitätsklinikum Schleswig-Holstein
    Full Title: Vereidung maschineller Beatmung bei sehr kleinen Frühgeborenen - Avoid mechanical ventilation (The AMV-Trial)
    Medical condition: Respiratory distress syndrom of preterm infants (ICD 10: P22.0)
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-004198-41 Sponsor Protocol Number: UCDCRC/16/003 Start Date*: 2017-01-27
    Sponsor Name:University College Dublin
    Full Title: PROPHYLACTIC OROPHARYNGEAL SURFACTANT FOR PRETERM INFANTS: A RANDOMISED TRIAL (THE POPART TRIAL)
    Medical condition: Preterm Infants at risk of respiratory distress syndrome
    Disease: Version SOC Term Classification Code Term Level
    19.0 10042613 - Surgical and medical procedures 10054933 Neonatal respiratory distress syndrome prophylaxis PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Completed) BE (Completed) SE (Completed) CZ (Completed) PT (Completed) NO (Completed)
    Trial results: View results
    EudraCT Number: 2020-001598-66 Sponsor Protocol Number: P20/06 Start Date*: 2020-05-04
    Sponsor Name:Centre Hospitalier de Versailles
    Full Title: Preliminary randomized controlled trial of poractant alfa (Curosurf®) by fiberoptic bronchoscopy-directed endobronchial administration in acute respiratory distress syndrome (ARDS) due to COVID-19 ...
    Medical condition: Acute respiratory distress syndrome due to COVID-19 viral pneumonia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-002550-30 Sponsor Protocol Number: DM/PR/5000/003/05 Start Date*: 2006-11-09
    Sponsor Name:Chiesi Farmaceutici S. p. A.
    Full Title: A randomized controlled pilot study for the comparison of efficacy of bronchoalveolar lavage (BAL) with Curosurf® in a dosage 50 mg/kg vs not treated control in adult patients affected by pulmonary...
    Medical condition: lung contusion
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-012817-23 Sponsor Protocol Number: MRU-09-02 Start Date*: 2009-09-08
    Sponsor Name:Maternite Regionale Universitaire de Nancy
    Full Title: Utilisation d’un surfactant exogène chez des nouveau-nés grands prématurés présentant une détresse respiratoire sévère en prévention de la dysplasie bronchopulmonaire
    Medical condition: Nouveau-né d’âge gestationnel inférieur à 33 semaines d’aménorrhée toujours sous ventilation assistée conventionnelle ou par oscillations à hautes fréquences (OHF), après 14+/-2 jours de vie, avec ...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001169-18 Sponsor Protocol Number: UoL001360 Start Date*: 2018-10-15
    Sponsor Name:University Of Liverpool
    Full Title: The efficacy and mechanism of surfactant therapy for critically ill infants with bronchiolitis: The Bronchiolitis Endotracheal Surfactant Study.
    Medical condition: Critical Illness due to Bronchiolitis of infancy requiring conventional invasive Mechanical Ventilation (MV) Diagnosis of bronchiolitis per clinical criteria defined in national guidance NICE-NG9.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10021881 - Infections and infestations 10038718 Respiratory syncytial virus bronchiolitis PT
    20.1 10021881 - Infections and infestations 10065188 Lower respiratory tract infection viral PT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2019-003764-45 Sponsor Protocol Number: UOL0727 Start Date*: 2020-02-14
    Sponsor Name:University of Leicester
    Full Title: Multicentre, open-label, randomised controlled trial of early surfactant therapy versus expectant management in late preterm and early term infants with respiratory distress.
    Medical condition: Respiratory distress in neonates born at 34 to 38+6 weeks of gestation
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-003233-14 Sponsor Protocol Number: 18CH129 Start Date*: Information not available in EudraCT
    Sponsor Name:CHU de Saint Etienne
    Full Title: Evaluation of the neonatal autonomic stress during intubations under Propofol in a population of premature infants under 33 w’GA
    Medical condition: population of premature infants under 33 w’GA requiring intubation for the administration of exogenous surfactant
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004868 10003969 Baby premature LLT
    20.0 100000004855 10020477 Hyaline membrane disease LLT
    20.1 100000004852 10002321 Anesthesia LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-004105-25 Sponsor Protocol Number: DM/PR/5000/002/04 Start Date*: 2007-02-12
    Sponsor Name:Chiesi Farmaceutici S p A
    Full Title: AN INTERNATIONAL, OPEN, RANDOMIZED, CONTROLLED STUDY TO EVALUATE THE EFFICACY OF COMBINING PROPHYLACTIC CUROSURF WITH EARLY NASAL CPAP VERSUS EARLY NASAL CPAP ALONE IN VERY PRETERM INFANTS AT RISK ...
    Medical condition: Neonatal Respiratory Distress Syndrome
    Disease: Version SOC Term Classification Code Term Level
    8.1 10028974 Neonatal respiratory distress syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed) IT (Completed) FR (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2013-005429-21 Sponsor Protocol Number: OPTIMIST-Aprotocol Start Date*: Information not available in EudraCT
    Sponsor Name:Menzies Research Institute Tasmania
    Full Title: Multicentre randomised controlled trial of minimally-invasive surfactant therapy in preterm infants 25-28 weeks gestation on continuous positive airway pressure (CPAP)
    Medical condition: Infant respiratory distress syndrome, also known as hyaline membrane disease.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004855 10020477 Hyaline membrane disease LLT
    Population Age: In utero, Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) Outside EU/EEA SI (Completed) NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2010-023668-42 Sponsor Protocol Number: CRI 102194 Start Date*: 2011-02-03
    Sponsor Name:Southampton University Hospital NHS Trust
    Full Title: Pulmonary surfactant (S) biology in ventilated children on a paediatric intensive care unit with acute (A) hypoxic respiratory (R) failure- a pilot (P) study (S): (SARPS)
    Medical condition: acute hypoxic respiratory failure in children ventilated on paediatric intensive care
    Disease: Version SOC Term Classification Code Term Level
    12.1 10040047 Sepsis PT
    12.1 10018985 Haemorrhage intracranial PT
    12.1 10006093 Bradycardia PT
    12.1 10021097 Hypotension PT
    12.1 10006475 Bronchopulmonary dysplasia PT
    12.1 10035759 Pneumothorax PT
    12.1 10037394 Pulmonary haemorrhage PT
    12.1 10058490 Hyperoxia PT
    12.1 10011705 Cyanosis neonatal PT
    12.1 10002974 Apnoea PT
    12.1 10033318 Oxygen saturation decreased PT
    12.1 10014408 Electroencephalogram abnormal PT
    12.1 10063349 Endotracheal intubation complication PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
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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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