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Clinical trials for Surfactant therapy

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   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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    25 result(s) found for: Surfactant therapy. Displaying page 1 of 2.
    1  2  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: 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: 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: 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: 2005-002687-29 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: 2013-002258-60 Sponsor Protocol Number: UMCN-ONCO-201302 Start Date*: 2013-08-30
    Sponsor Name:Radboud University Nijmegen Medical Centre
    Full Title: prediction of everolimus-induced interstitial lung disease in breast cancer patients; maximizing efficacy by reducing toxicity
    Medical condition: breast cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10072737 Advanced breast cancer LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2015-003878-33 Sponsor Protocol Number: MOL-PAP-002 Start Date*: 2016-01-28
    Sponsor Name:Savara ApS
    Full Title: A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients
    Medical condition: Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004855 10037316 Pulmonary alveolar proteinosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DK (Completed) NL (Completed) DE (Completed) GR (Completed) ES (Completed) IT (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2011-000811-23 Sponsor Protocol Number: Start Date*: 2012-06-22
    Sponsor Name:University Hospital Southampton NHS Foundation Trust
    Full Title: Treatment of neonatal chronic lung disease (nCLD). The Surfactant, Nutrition and Microorganism Interactions study in infants at risk of developing chronic lung disease - 2 (TSuNaMI-II)
    Medical condition: neonatal chronic lung disease bronchopulmonary dysplasia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10022117 - Injury, poisoning and procedural complications 10063349 Endotracheal intubation complication PT
    14.1 10042613 - Surgical and medical procedures 10044107 Total parenteral nutrition LLT
    14.1 10029205 - Nervous system disorders 10018985 Haemorrhage intracranial PT
    14.1 10021881 - Infections and infestations 10069719 Bacterial colonisation LLT
    14.1 10047065 - Vascular disorders 10021097 Hypotension PT
    14.1 10007541 - Cardiac disorders 10006093 Bradycardia PT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10002974 Apnoea PT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10037395 Pulmonary haemorrhage of fetus or newborn LLT
    14.1 10021881 - Infections and infestations 10040047 Sepsis PT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10035759 Pneumothorax PT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10058490 Hyperoxia PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-001486-90 Sponsor Protocol Number: P150944 Start Date*: 2016-06-24
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth: a randomized, multicentre, double blind placebo-controlled non inferiority ...
    Medical condition: Very preterm birth
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004868 10053593 Premature baby 26 to 32 weeks LLT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2011-000762-35 Sponsor Protocol Number: ID_2882 Start Date*: 2011-11-18
    Sponsor Name:A.O. UNIVERSITARIA INTEGRATA DI VERONA
    Full Title: EFFECTS OF THE VITAMIN D ADMINISTRATION ON RESPIRATORY FUNCTIONS IN PAEDIATRIC PATIENTS SUFFERING FROM EFFORT ASTHMA
    Medical condition: paediatric patients suffering from effort asthma
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003558 Asthma extrinsic LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-003181-12 Sponsor Protocol Number: HOTPOT1 Start Date*: 2016-10-07
    Sponsor Name:Royal College of Surgeons in Ireland
    Full Title: Can sonographic assessment of pulmonary vascular reactivity following maternal hyperoxygenation therapy predict neonatal outcome in fetuses at risk of pulmonary hypertension?
    Medical condition: Persistent pulmonary hypertension of the newborn (PPHN) is a relatively common condition occurring in 7/1000 births and can result in significant cardiovascular instability in the newborn. It occur...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2004-002312-29 Sponsor Protocol Number: INOT -27 Start Date*: 2005-01-10
    Sponsor Name:INO Therapeutics
    Full Title: The Effects of Nitric Oxide for Inhalation on the development of chronic lung disease in pre-term infants.
    Medical condition: Prevention of chronic lung disease in pre-term infants ( gestational age < 29 weeks) with respiratory distress.
    Disease: Version SOC Term Classification Code Term Level
    7.0 10054933 LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) SE (Completed) GB (Completed) DE (Completed) BE (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-001747-31 Sponsor Protocol Number: P160907 Start Date*: 2019-04-09
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: A Multi-center, Randomised, Double-blind Trial of Nintedanib in Lung Tranplant (LTx) recipients with bronchiolitis obliterans sydrome (BOS) grade 1-2
    Medical condition: Bronchiolitis Obliterating Syndrome (SBO) grade 1 or 2 in patients with pulmonary transplantation.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10029888 Obliterative bronchiolitis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-003138-18 Sponsor Protocol Number: UCC-Strider Start Date*: Information not available in EudraCT
    Sponsor Name:University College Cork
    Full Title: STRIDER Ireland: A Randomised Controlled Trial of Sildenafil Therapy In Dismal Prognosis Early‐Onset Intrauterine Growth Restriction
    Medical condition: Severe early - onset Intrauterine Growth Restriction (IUGR), (also referred to as Fetal growth restriction) diagnosed between 22+0 and 29+6 gestational age. IUGR is defined as an estimated fetal we...
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004868 10070532 Fetal growth restriction LLT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-010759-29 Sponsor Protocol Number: 001 Start Date*: 2009-04-27
    Sponsor Name:Cliniques Universitaires Saint-Luc
    Full Title: étude clinique sur l’administration de 3 doses de betaméthasone (12mg) à 18 heures d’intervalle lors d’une menace d’accouchement prématuré dans les grossesses gémellaires traitées par Atosiban, plu...
    Medical condition: Premature delivery in twin pregnancies
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036564 Pregnancy multiple LLT
    9.1 10028244 Multiple pregnancy affecting fetus or newborn LLT
    Population Age: In utero, Under 18, Adults Gender: Female
    Trial protocol: BE (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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