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Clinical trials for Birth injury

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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    115 result(s) found for: Birth injury. Displaying page 1 of 6.
    1  2  3  4  5  6  Next»
    EudraCT Number: 2017-004596-31 Sponsor Protocol Number: NL62772 Start Date*: 2019-03-25
    Sponsor Name:UMC Utrecht
    Full Title: CeRebrUm and CardIac protection with Allopurinol in neonates with critical congenital heart disease requiring cardiac surgery with cardiopulmonary bypass
    Medical condition: Brain injury in neonates with critical congenital heart disease requiring cardiac surgery with cardiopulmonary bypass.
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10010495 Congenital heart disease NOS LLT
    20.0 10029205 - Nervous system disorders 10067967 Brain injury PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2022-003382-38 Sponsor Protocol Number: FSNANO05012022 Start Date*: 2023-01-12
    Sponsor Name:FSNANO05012022
    Full Title: Efficacy and safety of Cerebrolysin for neurorecovery after moderate-severe traumatic brain injury
    Medical condition: Moderate-severe traumatic brain injury
    Disease: Version SOC Term Classification Code Term Level
    26.1 10022117 - Injury, poisoning and procedural complications 10060690 Traumatic brain injury LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2007-000083-24 Sponsor Protocol Number: GCPL/RGN/02 Start Date*: 2007-06-07
    Sponsor Name:Regen Therapeutics PLC
    Full Title: A survey of efficacy of zolpidem in patients with brain injury including SPECT brain scans in selected patients
    Medical condition: Brain damage of any original cause, such as strokes, trauma, birth injury, post-viral infection.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10056389 Brain damage LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Not Authorised)
    Trial results: (No results available)
    EudraCT Number: 2004-000763-98 Sponsor Protocol Number: HP184B/2002 Start Date*: 2004-12-08
    Sponsor Name:Aventis Pharmaceuticals Inc.
    Full Title: A phase II, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of HP184 at 100, 200 and 400 mg doses administered orally once daily for twenty-four weeks in adult...
    Medical condition: Chronic spinal cord injury
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-001581-20 Sponsor Protocol Number: IRRB/72/14 Start Date*: 2018-02-08
    Sponsor Name:ISTITUTO MEDITERRANEO PER I TRAPIANTI E TERAPIE AD ALTA SPECIALIZZAZIONE - ISMETT
    Full Title: THE ADDITION OF SIMVASTATIN ADMINISTRATION TO COLD STORAGE SOLUTION OF EXPLANTED WHOLE LIVER GRAFTS FOR FACING ISCHEMIA/REPERFUSION INJURY IN AN AREA WITH LOW RATE OF DECEASED DONATION. A MONOCENT...
    Medical condition: ISCHEMIC REPERFUSION INJURY AFTER LIVER TRANSPLANTATION: HEPATIC ISCHEMIA AND REPERFUSION INJURY REPRESENTS THE MAIN UNDERLYING MECHANISM FOR GRAFT DYSFUNCTION, AND FAILURE, POST-TRANSPLANTATION. H...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10047065 - Vascular disorders 10063837 Reperfusion injury PT
    20.0 10042613 - Surgical and medical procedures 10024714 Liver transplant PT
    20.1 10022117 - Injury, poisoning and procedural complications 10058060 Graft complication PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003113-15 Sponsor Protocol Number: QRK209 Start Date*: 2016-08-02
    Sponsor Name:Quark Pharmaceuticals, Inc.
    Full Title: A Randomized, Double-Blind, Placebo Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Acute Kidney Injury in Subjects at High Risk for AKI following Ca...
    Medical condition: QPI-1002 is being developed for prevention of acute kidney injury (AKI) in patients at risk for AKI following cardiac surgery and for reduction in the incidence and severity of delayed graft functi...
    Disease: Version SOC Term Classification Code Term Level
    19.1 10038359 - Renal and urinary disorders 10069339 Acute kidney injury PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-000222-19 Sponsor Protocol Number: H2020-PHC-18-2015-667224 Start Date*: 2017-08-02
    Sponsor Name:University Hospital Tuebingen
    Full Title: Effect of ALlopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome – a blinded randomized placebo-controlled parallel group multicenter trial for superiori...
    Medical condition: Perinatal Asphyxia, hypoxic-ischemic brain injury
    Disease: Version SOC Term Classification Code Term Level
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    20.0 10029205 - Nervous system disorders 10014633 Encephalopathy neonatal PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) NL (Trial now transitioned) NO (Trial now transitioned) ES (Ongoing) FI (Trial now transitioned) EE (Trial now transitioned) AT (Trial now transitioned) BE (Trial now transitioned) PT (Prematurely Ended) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-000612-34 Sponsor Protocol Number: EpoRepair Start Date*: 2015-12-15
    Sponsor Name:UniversitätsSpital Zürich
    Full Title: Erythropoietin for the repair of cerebral injury in very preterm infants, a randomized, double-blind, placebo-controlled, prospective, and multicenter clinical study
    Medical condition: 1 out of 100 children born extremely early, or more than 8 weeks before the expected date. 20% of these extremely preterm children shows a cerebral hemorrhage at birth, leading to a significantly i...
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-003728-39 Sponsor Protocol Number: Euro SPK 003 Start Date*: 2010-12-07
    Sponsor Name:Centre Hospitalier Universitaire de Liège
    Full Title: A EUROPEAN MULTICENTER OPEN-LABEL RANDOMIZED TRIAL TO EVALUATE THE REDUCTION OF ISCHEMIA / REPERFUSION INJURY AFTER DE NOVO SIMULTANEOUS PANCREAS/KIDNEY TRANSPLANTATION IN TYPE 1-DIABETIC PATIENTS ...
    Medical condition: End-stage, C-peptide-negative, type 1-diabetic patients undergoing a first combined pancreas/kidney transplantation from a cadaver donor only will be enrolled in the study
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2018-003640-23 Sponsor Protocol Number: IRRB/05/18 Start Date*: 2019-05-29
    Sponsor Name:ISTITUTO MEDITERRANEO PER I TRAPIANTI E TERAPIE AD ALTA SPECIALIZZAZIONE - ISMETT
    Full Title: USE OF HEPATITIS C+ DONORS FOR SOLID ORGAN TRANSPLANTATION IN A GEOGRAPHICAL AREA WITH HCV+ ENDEMIC INFECTION AND WITH A LOW-RATE CADAVERIC ORGAN DONOR AVAILABILITY. A PHASE II OPEN, MONOCENTRIC CL...
    Medical condition: USE OF POSITIVE DONORS FOR INFECTION OF THE HEPATITIS VIRUS FOR THE TRANSPLANTATION OF SOLID ORGANS IN AN ENDEMIC AREA FOR HEPATITIS C WITH LOW RATE OF DONATIONS FROM CADAVERS: OPEN PHASE II CLINI...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10042613 - Surgical and medical procedures 10024714 Liver transplant PT
    21.1 10047065 - Vascular disorders 10063837 Reperfusion injury PT
    20.1 10022117 - Injury, poisoning and procedural complications 10058060 Graft complication PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2013-004478-80 Sponsor Protocol Number: Issue1 Start Date*: 2014-01-08
    Sponsor Name:University Hospital Bristol NHS Foundation Trust
    Full Title: XENON AND COOLING THERAPY IN BABIES AT HIGH RISK OF BRAIN INJURY FOLLOWING POOR CONDITION AT BIRTH: A RANDOMISED OUTCOME STUDY (COOLXENON3 STUDY)
    Medical condition: Neonatal hypoxia-ischaemia (HI). There is no exact MedDRA term for this. The closest MedDRA terms matching this are neonatal asphyxia and neonatal hypoxia.
    Disease: Version SOC Term Classification Code Term Level
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    16.1 100000004868 10028946 Neonatal hypoxia and asphyxia HLT
    16.1 10038738 - Respiratory, thoracic and mediastinal disorders 10050081 Neonatal hypoxia PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2018-004792-13 Sponsor Protocol Number: NFX88-2A-2018 Start Date*: 2019-05-23
    Sponsor Name:Neurofix S.L.
    Full Title: A randomized, double-blind, placebo controlled, parallel group, multicentric, phase IIa clinical trial to evaluate the safety, tolerability and therapeutic efficacy of daily oral treatment with NF...
    Medical condition: Neuropathic pain in spinal cord injury patients.
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2021-004040-19 Sponsor Protocol Number: 21-ROS-05 Start Date*: 2022-02-09
    Sponsor Name:Guard Therapeutics International AB
    Full Title: A Phase 2, Randomized, Placebo-Controlled, Double-Blind, Adaptive, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Foll...
    Medical condition: Cardiac surgery associated acute kidney injury
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10069339 Acute kidney injury PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-000975-10 Sponsor Protocol Number: CME-LEM5 Start Date*: 2017-09-25
    Sponsor Name:Fundación Investigación Biomédica Hospital Universitario Puerta de Hierro Majadahonda
    Full Title: Intrathecal administration of bone marrow adult autologous stem mesenchymal cells expanded in chronically established low injuries of the spinal cord
    Medical condition: Traumatic or ischemic spinal cord injury, chronically established and considered irreversible
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-000757-49 Sponsor Protocol Number: QRK309 Start Date*: 2018-12-05
    Sponsor Name:Quark Pharmaceuticals, Inc.
    Full Title: A Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of QPI-1002 for the Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for A...
    Medical condition: QPI-1002 is being developed for prevention of acute kidney injury (AKI) in patients at risk for AKI following cardiac surgery and for reduction in the incidence and severity of delayed graft functi...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10069339 Acute kidney injury PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) ES (Prematurely Ended) GB (GB - no longer in EU/EEA) BE (Completed) CZ (Completed) AT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-000909-22 Sponsor Protocol Number: MDS-KET-2004-01 Start Date*: 2004-08-27
    Sponsor Name:MDS Pharma Services
    Full Title: Comparative efficacy and tolerability of a topical ketoprofen TDS patch vs ketoprofen gel in the treatment of acute pain in soft-tissue injuries
    Medical condition: Acute pain in soft-tissue injuries of lower limbs, except toes
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-002502-74 Sponsor Protocol Number: NEU-01-02-01 Start Date*: 2012-02-14
    Sponsor Name:Neurophyxia B.V.
    Full Title: A multi-centre, randomised, double-blind, placebo-controlled Phase II study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of 2-iminobiotin (2-IB) in neonates with gestational...
    Medical condition: Perinatal asphyxia
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10004943 Birth asphyxia LLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10003500 Asphyxia neonatal LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: LT (Prematurely Ended) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2011-001303-13 Sponsor Protocol Number: TMC114IFD3004 Start Date*: 2011-07-26
    Sponsor Name:Janssen Cilag
    Full Title: HIV postexposure prophylaxis with Darunavir/r (PEPDar)
    Medical condition: HIV postexposure prophylaxis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10042613 - Surgical and medical procedures 10054925 Prophylaxis against HIV infection PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-005397-34 Sponsor Protocol Number: Issue1 Start Date*: 2012-02-24
    Sponsor Name:University Hospital Bristol NHS Foundation Trust
    Full Title: Xenon and cooling therapy in babies at high risk of brain injury following poor condition at birth: Randomised pilot study. (CoolXenon2 study)
    Medical condition: Neonatal hypoxia-ischaemia (HI). There is no exact MedDRA term for this. The closest MedDRA terms matching this are neonatal asphyxia and neonatal hypoxia.
    Disease: Version SOC Term Classification Code Term Level
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10050081 Neonatal hypoxia PT
    14.1 10036585 - Pregnancy, puerperium and perinatal conditions 10028946 Neonatal hypoxia and asphyxia HLT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-004740-36 Sponsor Protocol Number: MINT (CRO1834) Start Date*: 2011-08-04
    Sponsor Name:Imperial College, London
    Full Title: Melatonin As A Novel Neuroprotectant In Preterm Infants−Trial Study
    Medical condition: Brain injury from prematurity
    Disease: Version SOC Term Classification Code Term Level
    14.0 10036585 - Pregnancy, puerperium and perinatal conditions 10013384 Disorders relating to short gestation and unspecified low birthweight LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: GB (Prematurely Ended)
    Trial results: View results
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