Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Bronchopulmonary Dysplasia AND Preterm Infants

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   44380   clinical trials with a EudraCT protocol, of which   7392   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    30 result(s) found for: Bronchopulmonary Dysplasia AND Preterm Infants. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2009-010381-30 Sponsor Protocol Number: 2.4 Start Date*: 2009-03-19
    Sponsor Name:Isala klinieken
    Full Title: Aerosolised salbutamol in two doses as a treatment for preterm infants with developing bronchopulmonary dysplasia.
    Medical condition: Preterm infants developing bronchopulmonary dysplasia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10006475 Bronchopulmonary dysplasia LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-012203-26 Sponsor Protocol Number: Grand_Award_Health-F5_2009-223060 Start Date*: 2009-11-19
    Sponsor Name:University Children's Hospital, Department of Neonatology
    Full Title: Efficacy and Safety of Inhaled Budesonide in Very Preterm Infants at Risk for Bronchopulmonary Dysplasia
    Medical condition: Survival of Extremely Low Birth Weight (ELBW) infants has improved in recent decades but Bronchopulmonary Dysplasia (BPD) remains a major health care problem. BPD is a chronic lung disease that occ...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed) FR (Completed) EE (Completed) CZ (Completed) BE (Completed) GR (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2013-003889-14 Sponsor Protocol Number: C12-75 Start Date*: 2014-12-09
    Sponsor Name:Institut National de la Santé et de la Research Médicale
    Full Title: A randomised, placebo controlled trial of azithromycin for the prevention of chronic lung disease of prematurity in preterm infants
    Medical condition: Bronchopulmonary Dysplasia
    Disease: Version SOC Term Classification Code Term Level
    17.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    17.1 10038738 - Respiratory, thoracic and mediastinal disorders 10066204 Chronic lung disease of prematurity LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) DE (Ongoing) NL (Ongoing) GB (GB - no longer in EU/EEA)
    Trial results: View results
    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: 2010-023777-19 Sponsor Protocol Number: SToP-BPD Start Date*: Information not available in EudraCT
    Sponsor Name:Academic Medical Center
    Full Title: Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants: the SToP-BPD study
    Medical condition: bronchopulmonary dysplasia
    Disease: Version SOC Term Classification Code Term Level
    12.1 10006475 Bronchopulmonary dysplasia LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-002653-26 Sponsor Protocol Number: PULMESCELL-2 Start Date*: 2023-07-21
    Sponsor Name:Fundación para la Investigación Biomédica Hospital Ramón y Cajal
    Full Title: PHASE II CLINICAL TRIAL TO ESTABLISH THE SAFETY OF THE USE OF EXPANDED ALLOGENEIC FETAL UMBILICAL CORD STEM MESENCHYMAL CELLS IN PRETERM PATIENTS WITH BRONCHOPULMONARY DYSPLASIA
    Medical condition: Live newborns weighing ≤ 1250 grams and gestational age ≤ 28 weeks, who are on mechanical ventilation with a FiO2 ≥ 0.3 between days 5 and 14 of life, with no immediate extubation foreseeable
    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, Newborns, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-000253-21 Sponsor Protocol Number: CLA-CC10-02 Start Date*: Information not available in EudraCT
    Sponsor Name:Therabron Therapeutics Inc.
    Full Title: Efficacy of recombinant human club (clara) cell 10kDa protein (CC10) administered to premature neonates with respiratory distress syndrome.
    Medical condition: Bronchopulmonary Dysplasia (BPD)
    Disease: Version SOC Term Classification Code Term Level
    18.0 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Ongoing) PL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-000453-41 Sponsor Protocol Number: BMBF-Fz01KG1602 Start Date*: 2018-05-29
    Sponsor Name:University Hospital Tuebingen
    Full Title: Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants – a randomized controlled parallel group multicenter trial for safety...
    Medical condition: Extremely low gestational age neonates (ELGANs), i.e. those who are born at <28 weeks gestation and who uniformly suffer from intermittent hypoxemic episodes.
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    20.1 10015919 - Eye disorders 10038933 Retinopathy of prematurity PT
    20.1 10017947 - Gastrointestinal disorders 10055667 Necrotising enterocolitis neonatal PT
    20.1 10018065 - General disorders and administration site conditions 10011912 Death neonatal PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10071101 Primary apnoea of premature newborns LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2008-001368-35 Sponsor Protocol Number: 31520 Start Date*: 2008-04-24
    Sponsor Name:Oulu University Hospital
    Full Title: Efficacy and Safety of Targeting Lower Arterial Oxygen Saturations to Reduce Oxygen Toxicity and Oxidative Stress in Very Preterm Infants
    Medical condition: Study population: Children born extremely preterm (before 28 weeks of gestation). Primary outcome: 1) Death before a corrected age of 18 months and survival with severe disability. 2) The growth ...
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036615 Prematurity LLT
    Population Age: Preterm newborn infants, Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed)
    Trial results: (No results available)
    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: 2013-001998-24 Sponsor Protocol Number: ME3827/1-1 Start Date*: 2014-10-09
    Sponsor Name:Saarland University
    Full Title: A prospective, multicenter, double blind, placebo-controlled, two-arm parallel group phase 3 trial to evaluate the effect of early postnatal additional high dose oral vitamin A supplementation of 5...
    Medical condition: Preventing bronchopulmonary dysplasia (BPD) or death in extremely-low-birth-weight (ELBW) infants.
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    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: 2018-001393-16 Sponsor Protocol Number: SHP607-202 Start Date*: 2019-06-21
    Sponsor Name:Premacure AB
    Full Title: A Phase 2b, Multicenter, Randomized, Open-label, Controlled, 3-Arm Study to Evaluate the Clinical Efficacy and Safety of SHP607 in Preventing Chronic Lung Disease Through 12 Months Corrected Age Co...
    Medical condition: Chronic Lung Disease
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004855 10066204 Chronic lung disease of prematurity LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Trial now transitioned) SE (Prematurely Ended) FR (Completed) DE (Trial now transitioned) PT (Trial now transitioned) ES (Temporarily Halted) FI (Trial now transitioned) NL (Trial now transitioned) PL (Prematurely Ended) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2011-005717-36 Sponsor Protocol Number: 1645-CI-057 Start Date*: 2012-06-14
    Sponsor Name:Instituto de Investigación Sanitaria La Fe
    Full Title: Extremely low gestational age neonates randomly an assigned to be blindly resuscitated with 21% vs. 60% oxygen: influence upon mortality and chronic conditions in the neonatal period.
    Medical condition: Preterm infants aged 30 weeks or less, who need resuscitation / stabilization maneuvers with positive pressure ventilation immediately after birth
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-004297-26 Sponsor Protocol Number: C19-29 Start Date*: 2020-04-17
    Sponsor Name:Institut National de la Santé et de la Recherche Médicale (INSERM)
    Full Title: Prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen
    Medical condition: Patent ductus arteriosus
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) EE (Completed) IE (Completed) FI (Completed) BE (Completed) PT (Completed) SE (Completed) HU (Completed) DK (Completed) GB (Not Authorised) NO (Completed) AT (Completed) GR (Completed) PL (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-004260-22 Sponsor Protocol Number: ELFIN01 Start Date*: 2013-08-28
    Sponsor Name:University of Oxford
    Full Title: A multi-centre randomised placebo-controlled trial of prophylactic enteral lactoferrin supplementation to prevent late-onset invasive infection in very preterm infants.
    Medical condition: Late onset invasive infection in very preterm infants
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2010-018771-23 Sponsor Protocol Number: 2010-0128771-23 Start Date*: 2010-03-03
    Sponsor Name:AZIENDA OSPEDALIERA "S. CROCE E CARLE"
    Full Title: Therapy of patency of ductus arteriosus (PDA) in very low birth weight (VLBW)preterm infants: oral ibuprofen versus intravenous ibuprofen
    Medical condition: treatment on pharmacological closure of patent ductus arteriosus (PDA)in preterm very low birthweight infants.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028920 HLGT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-003177-14 Sponsor Protocol Number: IBUPAR-Trial Start Date*: 2016-04-06
    Sponsor Name:
    Full Title: Paracetamol versus ibuprofen in preterm infants with a hemodynamically significant patent ductus arteriosus: a randomized clinical trial.
    Medical condition: Persistent ductus arteriosus haemodynamically significant
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (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: 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
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Thu Feb 12 07:26:21 CET 2026 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA