Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Bronchopulmonary dysplasia

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   44335   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 ).  
     
    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
     
    63 result(s) found for: Bronchopulmonary dysplasia. Displaying page 1 of 4.
    1  2  3  4  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: 2020-000529-19 Sponsor Protocol Number: TUD-TRIBOR-072 Start Date*: 2020-12-14
    Sponsor Name:Technische Universität Dresden
    Full Title: A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CROSS-OVER STUDY FOR EVALUATION OF THE EFFICIENCY AND SAFETY OF TIOTROPIUM INHALATION SOLUTION (5 µG) VIA RESPIMAT® INHALER once a day for 24 weeks fo...
    Medical condition: Children (6-12 years old) with bronchopulmonary dysplasia
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    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: 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: 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: 2014-003108-56 Sponsor Protocol Number: PULMESCEL-1 Start Date*: 2018-02-09
    Sponsor Name:Fundación para la investigación biomédica del Hospital Ramón y Cajal
    Full Title: Clinical Trial: Feaseability and security of the treatment of Bronchopulmonary Dysplasia in preterm babies with expanded umbilical cord allogenic fetal mesenchymal stem cells.
    Medical condition: 10 preterm babies under 28 weeks of gestational age and under 1250 grams of weight, at high risk of presenting pulmonary damage.
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005752-10 Sponsor Protocol Number: AT-100/001 Start Date*: 2023-04-20
    Sponsor Name:Airway Therapeutics, Inc.
    Full Title: A Phase 1b, Randomized, Blinded, Dose-Determined Study Evaluating the Safety and Tolerability Profile of Intervention with AT-100 (rhSP-D) in Preterm Neonates at High Risk for the Development of Br...
    Medical condition: Bronchopulmonary Dysplasia (BPD)
    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: IT (Ongoing)
    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: 2022-003202-77 Sponsor Protocol Number: NEOKOFF22 Start Date*: 2023-04-04
    Sponsor Name:
    Full Title: The effect of additional pre-extubational loading dose of caffeine-citrate
    Medical condition: Extubation failure and bronchopulmonary dysplasia
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10002973 Apnea neonatal LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10071132 Primary apnea of premature newborns LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077322 Infantile apnea LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077325 Infantile obstructive apnea LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10077328 Infantile central apnea LLT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028975 Neonatal respiratory failure PT
    21.1 10038738 - Respiratory, thoracic and mediastinal disorders 10006475 Bronchopulmonary dysplasia PT
    20.0 100000004868 10076729 Very preterm infant LLT
    23.1 100000004868 10084217 Extremely preterm (less than 28 weeks) LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: HU (Trial now transitioned)
    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: 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: 2020-002726-84 Sponsor Protocol Number: SHP607-203 Start Date*: Information not available in EudraCT
    Sponsor Name:Premacure AB
    Full Title: Long-Term Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment with SHP607 in Extremely Premature Infants
    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: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-005342-63 Sponsor Protocol Number: UoL001206 Start Date*: 2016-06-23
    Sponsor Name:University of Liverpool
    Full Title: Mindex: The efficacy and safety of very low dose dexamethasone used to facilitate the extubation of ventilator dependent preterm babies who are at high risk of bronchopulmonary dysplasia
    Medical condition: Bronchopulmonary dysplasia
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (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: 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)
    EudraCT Number: 2008-005987-15 Sponsor Protocol Number: The Triple P study Start Date*: 2009-10-22
    Sponsor Name:AMC Amsterdam
    Full Title: Preventing preterm birth: Costs and effects of screening of healthy women with a singleton pregnancy for a short cervical length.
    Medical condition: Preterm birth with healthy singleton pregnancies
    Disease: Version SOC Term Classification Code Term Level
    9.1 10036600 Premature labour LLT
    Population Age: Adults Gender: Female
    Trial protocol: NL (Ongoing)
    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)
    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  3  4  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-Sat May 10 17:12:26 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA