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Clinical trials for Ductus Arteriosus

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
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    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43881   clinical trials with a EudraCT protocol, of which   7295   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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    69 result(s) found for: Ductus Arteriosus. Displaying page 1 of 4.
    1  2  3  4  Next»
    EudraCT Number: 2011-003063-30 Sponsor Protocol Number: BRD10/6-O Start Date*: Information not available in EudraCT
    Sponsor Name:CHU Nantes
    Full Title:
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    14.1 10010331 - Congenital, familial and genetic disorders 10034130 Patent ductus arteriosus PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-004245-37 Sponsor Protocol Number: UCDCRC/20/05 Start Date*: 2020-12-18
    Sponsor Name:University College Dublin
    Full Title: Randomised Placebo-Controlled Trial of Early Targeted Treatment of Patent Ductus Arteriosus with Paracetamol in Extremely Low Birth Weight Infants (ETAPA)
    Medical condition: Patent Ductus Arteriosus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10034130 Patent ductus arteriosus PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Ongoing) CZ (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2009-011279-56 Sponsor Protocol Number: IBU/20mg/2009 Start Date*: 2009-07-31
    Sponsor Name:Orphan Europe Recordati
    Full Title: Multicenter open-label pilot study to evaluate the safety, pharmacology and efficacy of a new dose regimen (i.e. 20-10-10 mg/kg) of Pedea (intravenous ibuprofen) in preterm newborn infants of less ...
    Medical condition: Hemodynamically significant persisting ductus arteriosus in preterm infants of less than 28 weeks of gestational age
    Disease: Version SOC Term Classification Code Term Level
    9.1 10034130 Patent ductus arteriosus LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-003611-21 Sponsor Protocol Number: 2013-003611-21 Start Date*: 2013-12-20
    Sponsor Name:Karolinska Institutet
    Full Title: Safety of fluconazol treatment of premature and full-term newborns - a study on interactions by NSAIDs with fluconazole in respect of pharmacodynamic endpoints with urinary excretion of vas...
    Medical condition: Fungal infection prophylaxis Patent ductus arteriosus
    Disease: Version SOC Term Classification Code Term Level
    16.1 10010331 - Congenital, familial and genetic disorders 10034130 Patent ductus arteriosus PT
    16.1 10021881 - Infections and infestations 10028924 Neonatal candida infection PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-004526-33 Sponsor Protocol Number: PDARCT1 Start Date*: Information not available in EudraCT
    Sponsor Name:Royal College of Surgeons in Ireland
    Full Title: A Randomised Controlled Trial of Early Targeted Patent Ductus Arteriosus Treatment Using a Risk Based Severity Score
    Medical condition: Patent Ductus Arteriosus
    Disease: Version SOC Term Classification Code Term Level
    18.1 10010331 - Congenital, familial and genetic disorders 10034130 Patent ductus arteriosus PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2013-003883-30 Sponsor Protocol Number: 044CF13273 Start Date*: 2014-01-30
    Sponsor Name:Aziende Chimiche Riunite Angelini Francesco ACRAF S.p.A
    Full Title: Efficacy and safety of paracetamol in comparison to ibuprofen for patent ductus arteriosus treatment in preterm infants. A randomized, open label, comparator-controlled, prospective study.
    Medical condition: Patent ductus arteriosus
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004865 10034190 PDA Repair patent ductus arteriosus LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-002974-11 Sponsor Protocol Number: IBU24h-EchoG Start Date*: 2016-11-10
    Sponsor Name:María Carmen Bravo Laguna
    Full Title: Phase III, randomized, multicenter, double-blind clinical trial to evaluate two echo-guided administration regimens of ibuprofen in the treatment of patent ductus arteriosus: impact on intestinal p...
    Medical condition: patent ductus arteriosus
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10034130 Patent ductus arteriosus PT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2013-004955-19 Sponsor Protocol Number: PARIDA-01/2013 Start Date*: 2014-09-03
    Sponsor Name:Azienda Ospedaliera di Padova
    Full Title: PARACETAMOL VERSUS IBUPROFEN FOR PATENT DUCTUS ARTERIOSUS TREATMENT IN PRETERM INFANTS.
    Medical condition: patent ductus arteriosus hemodynamically important
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004865 10034190 PDA Repair patent ductus arteriosus LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-000565-36 Sponsor Protocol Number: 38/2018 Start Date*: 2018-06-05
    Sponsor Name:University of Oulu
    Full Title: Paracetamol and ibuprofen/indomethacin in closing persistent ductus arteriosus
    Medical condition: Patent ductus arteriosus of a premature infant
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FI (Ongoing)
    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 (Ongoing) EE (Ongoing) IE (Restarted) FI (Ongoing) BE (Ongoing) PT (Restarted) SE (Ongoing) HU (Ongoing) DK (Completed) GB (Not Authorised) NO (Completed) AT (Ongoing) GR (Ongoing) PL (Ongoing) 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: 2018-000566-11 Sponsor Protocol Number: 39-2018 Start Date*: 2018-06-05
    Sponsor Name:University of Oulu
    Full Title: Extremely low gestational age infants' PARAcetamol Study
    Medical condition: Open ductus arteriosus of a premature infant
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FI (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-001376-28 Sponsor Protocol Number: NL57885.091.16 Start Date*: 2017-04-20
    Sponsor Name:Radboud University Medical Center
    Full Title: Multi-center, randomized non-inferiority trial of early treatment versus expectative management of patent ductus arteriosus in preterm infants.
    Medical condition: Patent ductus arteriosus in the preterm infant
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) BE (Completed) LU (Ongoing)
    Trial results: View results
    EudraCT Number: 2013-001842-33 Sponsor Protocol Number: 100-2013 Start Date*: 2013-08-19
    Sponsor Name:OYS
    Full Title: The Preterm infants’ Paracetamol Study -- PreParaS
    Medical condition: premature infant
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004868 10036615 Prematurity LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FI (Restarted)
    Trial results: (No results available)
    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: 2011-000735-80 Sponsor Protocol Number: 2010-382 Start Date*: 2011-05-16
    Sponsor Name:Lene Drasbek Huusom
    Full Title: Administration of antenatal magnesium sulphate for prevention of cerebral palsy in preterm infants (MASP-STUDY)
    Medical condition: Moderate to severe cerebral palsy
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-005336-23 Sponsor Protocol Number: Baby-OSCAR Start Date*: 2014-12-16
    Sponsor Name:University of Oxford
    Full Title: Outcome After Selective Early Treatment for Closure of Patent Ductus Arteriosus in Pre-term Babies
    Medical condition: Patent ductus arteriosus of the newborn
    Disease:
    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: 2016-000134-22 Sponsor Protocol Number: MDCO-CAN-15-01 Start Date*: 2021-01-14
    Sponsor Name:Chiesi Farmaceutici S.p.A.
    Full Title: A Prospective, Open-Label, Single-Arm, Multi-Center Study to Assess The Pharmacokinetics/Pharmacodynamics (PK/PD) AND Safety Of Different Cangrelor Doses In Neonatal Subjects At Risk Of Thrombosis.
    Medical condition: Postoperative neonatal cardiac subjects who are undergoing surgery for placement of systemic-to pulmonary artery palliative shunts (e.g., Blalock-Taussig or central shunt), right ventricle to pulmo...
    Disease:
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    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: 2016-000221-39 Sponsor Protocol Number: M15-539 Start Date*: 2017-12-14
    Sponsor Name:AbbVie Inc
    Full Title: A Prospective, International, Multicenter, Open-Label, Non-Controlled Study of Safety and Effectiveness of Palivizumab, in Children at High Risk of Severe Respiratory Syncytial Virus (RSV) Infectio...
    Medical condition: Severe Respiratory Syncytial Virus (RSV) Infection
    Disease:
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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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