Flag of the European Union EU Clinical Trials Register Help

Clinical trials for 2011-000811-23

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.

    The EU Clinical Trials Register currently displays   42867   clinical trials with a EudraCT protocol, of which   7062   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 in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
    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
    1 result(s) found for: 2011-000811-23. Displaying page 1 of 1.
    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)
    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.
    Query did not match any studies.
    For support, visit the EMA Service Desk , log in using your EMA account and open a ticket specifying "EU CTR" in your request.
    If you do not have an account, please visit the EMA Account management page page click on "Create an EMA account" and follow the instructions.
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2022 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice