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Clinical trials for Meconium aspiration syndrome

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 ).  
     
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    4 result(s) found for: Meconium aspiration syndrome. Displaying page 1 of 1.
    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: 2014-004166-23 Sponsor Protocol Number: A1481157 Start Date*: 2015-05-11
    Sponsor Name:Pfizer, Inc.
    Full Title: A 7-Day, Open-Label, Multicenter, Pharmacokinetic (PK) Study (Part 1) Followed by A 7-Day, Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel Group Study (Part 2) of ...
    Medical condition: Persistent Pulmonary Hypertension of the Newborn (PPHN) or Hypoxic Respiratory Failure and at Risk for PPHN
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-002619-24 Sponsor Protocol Number: A1481316 Start Date*: 2013-03-04
    Sponsor Name:Pfizer Inc., 235 East 42nd Street, New York, NY 10017
    Full Title: A MULTI-CENTRE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, TWO-ARMED, PARALLEL GROUP STUDY TO EVALUATE EFFICACY AND SAFETY OF IV SILDENAFIL IN THE TREATMENT OF NEONATES WITH PERSISTENT PULMONA...
    Medical condition: Persistent pulmonary hypertension of the newborn
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053592 Newborn persistent pulmonary hypertension LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) SE (Completed) ES (Prematurely Ended) AT (Completed) DE (Completed) NO (Completed) IT (Completed) NL (Completed) DK (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2009-016248-37 Sponsor Protocol Number: A1481276 Start Date*: 2010-07-15
    Sponsor Name:Pfizer Ltd., Ramsgate Road, Sandwich, Kent. CT13 9NJ UNITED KINGDOM
    Full Title: A SINGLE ARM SINGLE CENTRE STUDY TO INVESTIGATE SAFETY AND EFFICACY OF SILDENAFIL IN NEAR TERM AND TERM NEWBORNS WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN)
    Medical condition: Persistent pulmonary hypertension of the newborn (PPHN)
    Disease: Version SOC Term Classification Code Term Level
    12.1 10053592 Newborn persistent pulmonary hypertension LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    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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