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Clinical trials for Leukomalacia

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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    29 result(s) found for: Leukomalacia. Displaying page 1 of 2.
    1  2  Next»
    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: 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: 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: 2013-005429-21 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: 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: 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: 2008-000896-30 Sponsor Protocol Number: Uni-Koeln-439 Start Date*: 2009-02-09
    Sponsor Name:University of Cologne
    Full Title: Surfactant application during spontaneous breathing with CPAP or during mechanical ventilation in the therapy of IRDS in premature infants <27 weeks
    Medical condition: Idiopathic Respiratory Distress Syndrome (IRDS) in preterm infants
    Disease: Version SOC Term Classification Code Term Level
    14.0 10038738 - Respiratory, thoracic and mediastinal disorders 10021735 Infant respiratory distress syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    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: 2016-001486-90 Sponsor Protocol Number: P150944 Start Date*: 2016-06-24
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Dose reduction of antenatal betamethasone given to prevent the neonatal complications associated with very preterm birth: a randomized, multicentre, double blind placebo-controlled non inferiority ...
    Medical condition: Very preterm birth
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004868 10053593 Premature baby 26 to 32 weeks LLT
    Population Age: Adults Gender: Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-000315-76 Sponsor Protocol Number: 1375_RCF_MAC Start Date*: 2021-12-06
    Sponsor Name:Centro Hospitalar Universitário de Lisboa Central, EPE
    Full Title: Low molecular weight heparin in the treatment of early fetal growth restriction
    Medical condition: Early fetal growth restriction
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004868 10070532 Fetal growth restriction LLT
    Population Age: Adults Gender: Female
    Trial protocol: PT (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: 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: (No results available)
    EudraCT Number: 2013-002845-12 Sponsor Protocol Number: NEOCIRC-001 Start Date*: 2013-12-03
    Sponsor Name:SERMAS (Hospital la Paz)
    Full Title: An international multicentre open-label comparative therapeutic exploratory trial to investigate the role of a new neonatal formulation of dobutamine in the treatment of haemodynamic insufficiency ...
    Medical condition: babies with evidence of haemodynamic insufficiency within 72 hours after birth
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Restarted) GB (Completed) HU (Completed)
    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
    EudraCT Number: 2011-002962-19 Sponsor Protocol Number: SKA 001 Start Date*: 2011-10-04
    Sponsor Name:University College Dublin
    Full Title: CHLORHEXIDINE VERSUS POVIDONE-IODINE FOR SKIN ANITSEPSIS PRIOR TO CENTRAL VENOUS CATHETER INSERTION IN PRETERM INFANTS: PROTOCOL FOR A RANDOMISED TRIAL (THE SKA TRIAL)
    Medical condition: Blood stream infections in neonates
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2015-000456-15 Sponsor Protocol Number: 3518 Start Date*: 2015-05-19
    Sponsor Name:Kings College London [...]
    1. Kings College London
    2. Guys and St Thomas' NHS Foundation Trust
    Full Title: The prevention of pre-term birth in women who develop a short cervix. A multi-centre randomised controlled trial to compare three treatments; cervical cerclage, cervical pessary and vaginal proges...
    Medical condition: Short Cervix in Pregnancy
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004868 10021632 Incompetent cervix LLT
    Population Age: Adults Gender: Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2012-000622-22 Sponsor Protocol Number: ASAP Start Date*: 2012-07-20
    Sponsor Name:Fundació Clínic per a la Recerca Biomèdica
    Full Title: Aspirin for the enhancement of trophoblastic invasion in women with abnormal uterine artery Doppler at 11-14 weeks of gestation
    Medical condition: Placental insufficiency
    Disease: Version SOC Term Classification Code Term Level
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10035138 Placental insufficiency PT
    Population Age: Adults Gender: 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: 2019-002548-26 Sponsor Protocol Number: 0139 Start Date*: 2020-12-16
    Sponsor Name:Royal College of Surgeons in Irlenad
    Full Title: Can Pentoxifylline improve long-term outcomes in preterm infants with late-onset sepsis or necrotizing enterocolitis? A pragmatic, randomised, placebo controlled trial
    Medical condition: Late onset sepsis & necrotising enterocolitis
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004862 10053598 Late onset neonatal sepsis LLT
    20.1 100000004856 10028884 Necrotising enterocolitis LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2010-023988-17 Sponsor Protocol Number: 260777 Start Date*: 2014-04-04
    Sponsor Name:BrepCo Biopharma Limited
    Full Title: Management of Hypotension In the Preterm: A multi centre, randomised, controlled trial of hypotension management in the extremely low gestational age newborn
    Medical condition: Low Blood Pressure
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004866 10024895 Low blood pressure LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) CZ (Prematurely Ended) BE (Prematurely Ended) GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
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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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