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Clinical trials for Surfactant

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • 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   44334   clinical trials with a EudraCT protocol, of which   7366   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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    59 result(s) found for: Surfactant. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2020-001886-35 Sponsor Protocol Number: RHMCRI0399 Start Date*: 2020-05-15
    Sponsor Name:University Hospital Southampton NHS Foundation Trust
    Full Title: A clinical trial of nebulized surfactant for the Treatment of moderate to severe COVID-19 in adults
    Medical condition: COVID-19 infection in patients requiring endotrachael intubation
    Disease: Version SOC Term Classification Code Term Level
    23.0 10021881 - Infections and infestations 10051905 Coronavirus infection PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2021-005495-19 Sponsor Protocol Number: pro.LISA_01_21 Start Date*: 2022-01-19
    Sponsor Name:University Hospital Schleswig-Holstein
    Full Title: A randomized controlled trial in preterm infants comparing prophylactic with selective “Less Invasive Surfactant Administration” (PRO-LISA)
    Medical condition: Respiratory distress syndrome of premature infants
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-002383-38 Sponsor Protocol Number: OY062018 Start Date*: 2018-10-17
    Sponsor Name:University of Oulu
    Full Title: Premedication for less invasive surfactant administration
    Medical condition: The aim of this randomized, controlled trial is to evaluate the feasibility, efficacy and safety of less invasive surfactant administration (LISA) protocol with the premedication of either ketamine...
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FI (Trial now transitioned)
    Trial results: (No results available)
    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: 2022-003106-72 Sponsor Protocol Number: IIBSP-SUR-2022-61 Start Date*: 2023-05-26
    Sponsor Name:Institut de Recerca H. de la Santa Creu i Sant Pau
    Full Title: Single-blind randomized clinical trial in premature infants with Respiratory Distress Syndrome (RDS) amenable to treatment with exogenous surfactant identified early by pulmonary ultrasonography
    Medical condition: Respiratory Distress Syndrome
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    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: 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: 2008-003224-31 Sponsor Protocol Number: 557087CE Start Date*: 2008-03-10
    Sponsor Name:AZIENDA OSPEDALIERA DI PADOVA
    Full Title: EFFECT OF SURFACTANT IN the CINETIC AND INFLAMMATION IN the NEW-BORN PRETERM WHIT RDS SINDROM.
    Medical condition: PREMATURY NEWBORN WITH WEIGTH = OR < TO 1250g IN ARTIFICIAL VENTILATION
    Disease: Version SOC Term Classification Code Term Level
    9.1 10038692 Respiratory distress syndrome in newborn LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    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: 2020-005319-33 Sponsor Protocol Number: BuS2020 Start Date*: 2021-09-22
    Sponsor Name:Fundación Cínic per a la Reserca Biomèdica
    Full Title: EFFICACY AND SAFETY OF THE INTRATRACHEAL ADMINISTRATION OF BUDESONIDE WITH SURFACTANT IN VERY PRETERM INFANTS TO PREVENT BRONCHOPULMONARY DYSPLASIA: RANDOMIZED CLINICAL TRIAL
    Medical condition: Bronchopulmonary dysplasia of prematurity
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-002876-41 Sponsor Protocol Number: 38RC18.123 Start Date*: 2019-03-27
    Sponsor Name:CHU Grenoble-Alpes
    Full Title: Assesment of Propofol sedation during intra tracheal surfactant administration by the LISA method (Less Invasive Surfactant Administration)
    Medical condition: Respiratory Distress Syndrome of preterm babies born < 32 weeks of gestational age
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    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: 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: 2019-002923-13 Sponsor Protocol Number: 2535 Start Date*: 2021-04-15
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA OSPEDALI RIUNITI DI ANCONA
    Full Title: Indication for the exougenous surfactant administration to treat neonatal respiratory distress syndrome in the preterm infant: a single-center randomized phase 4 trial based on the comparison of tw...
    Medical condition: Neonatal respiratory distress syndrome (RDS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10038690 Respiratory distress syndrome (neonatal) LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-000489-37 Sponsor Protocol Number: SURF-04-01 Start Date*: 2005-08-26
    Sponsor Name:Nektar Therapeutics
    Full Title: An open label, randomized, controlled study to evaluate the safety and efficacy of aerosolized surfactant, Curosurf®, delivered via nasal continuous positive airway pressure pulmonary drug delivery...
    Medical condition: The medical condition for this application is the Respiratory Distress Syndrome (RDS). RDS, also known as hyaline membrane disease, is characterized by lung immaturity and surfactant deficiency a...
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-016608-22 Sponsor Protocol Number: PHRCIR09-DrTOURNEUX Start Date*: 2010-01-27
    Sponsor Name:CHU AMIENS
    Full Title: Administration de Surfactant précoce : Evaluation chez le Nouveau-né ≥ 35 semaines d’aménorrhée présentant une détresse respiratoire
    Medical condition: Détresse respiratoire du nouveau-né entre 35 et 41 semaines d'aménorrhées
    Disease:
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-002687-29 Sponsor Protocol Number: HCSAM05 Start Date*: 2006-06-08
    Sponsor Name:XAVIER CARBONELL ESTRANY
    Full Title: Single-dose dexamethasone and/or bronchoalveolar lavage with diluted surfactant in the treatment of severe meconium aspiration syndrome
    Medical condition: Severe meconium aspiration syndrome
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2008-000896-30 Sponsor Protocol Number: Uni-Koeln-439 Start Date*: 2009-02-09
    Sponsor Name:University of Cologne
    Full Title: Surfactant application during spontaneous breathing with CPAP or during mechanical ventilation in the therapy of IRDS in premature infants <27 weeks
    Medical condition: Idiopathic Respiratory Distress Syndrome (IRDS) in preterm infants
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021735 Infant respiratory distress syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-001331-22 Sponsor Protocol Number: CCD-1011-PR-0059 Start Date*: 2012-05-07
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: A FIRST IN HUMAN CLINICAL STUDY ON THE SAFETY AND TOLERABILITY OF TWO ESCALATING SINGLE DOSES OF CHF 5633 (SYNTHETIC SURFACTANT) IN PRETERM NEONATES WITH RESPIRATORY DISTRESS SYNDROME
    Medical condition: preterm neonates with Respiratory Distress Syndrome (RDS)
    Disease: Version SOC Term Classification Code Term Level
    16.0 10038738 - Respiratory, thoracic and mediastinal disorders 10038690 Respiratory distress syndrome (neonatal) LLT
    16.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028974 Neonatal respiratory distress syndrome PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) CZ (Completed)
    Trial results: View results
    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
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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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