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Clinical trials for Asphyxia Neonatorum

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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    • 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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    8 result(s) found for: Asphyxia Neonatorum. Displaying page 1 of 1.
    EudraCT Number: 2015-003063-12 Sponsor Protocol Number: NEU-01-02-1A Start Date*: 2016-09-14
    Sponsor Name:Neurophyxia B.V.
    Full Title: TIBC study: A multiple-centre Phase 2 trial comparing the efficacy of 2-Iminobiotin (2-IB) treatment to standard care in neonates with gestational age of ≥36 weeks with moderate to severe perinatal...
    Medical condition: Perinatal asphyxia
    Disease: Version SOC Term Classification Code Term Level
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10003500 Asphyxia neonatal LLT
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10028923 Neonatal asphyxia PT
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10004943 Birth asphyxia LLT
    19.0 100000004868 10028946 Neonatal hypoxia and asphyxia HLT
    19.0 100000004852 10021147 Hypoxic encephalopathy LLT
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10022820 Intrauterine hypoxia and birth asphyxia LLT
    19.0 10038738 - Respiratory, thoracic and mediastinal disorders 10040441 Severe birth asphyxia LLT
    19.0 100000004852 10070512 Hypoxic-ischemic encephalopathy LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: (No results available)
    EudraCT Number: 2006-005796-18 Sponsor Protocol Number: 03-217 Start Date*: 2009-07-21
    Sponsor Name:WKZ / UMC Utrecht
    Full Title: Does antenatal allopurinol during asphyxia reduce post-hypoxic-ischemic reperfusion damage in the newborn?
    Medical condition: Perinatal asphyxia
    Disease: Version SOC Term Classification Code Term Level
    9.1 10004943 Birth asphyxia LLT
    9.1 10014633 Encephalopathy neonatal LLT
    Population Age: In utero, Preterm newborn infants, Newborns, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-004265-25 Sponsor Protocol Number: 2-STEP Start Date*: 2015-04-15
    Sponsor Name:University Medical Centre Utrecht
    Full Title: 2-STEP: A single-centre, phase II study to evaluate the safety, tolerability and pharmacokinetics of 2-Iminobiotin (2-IB) in neonates with gestational age of ≥36 weeks with moderate to severe perin...
    Medical condition: Perinatal asphyxia
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004855 10003500 Asphyxia neonatal LLT
    19.0 100000004855 10004943 Birth asphyxia LLT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-014260-19 Sponsor Protocol Number: CH/2009/3187 Start Date*: 2010-01-29
    Sponsor Name:University Hospital Bristol NHS Foundation Trust
    Full Title: A feasibility study of adding xenon to cooling therapy in babies at high risk of brain injury following poor condition at birth
    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
    12 10028923 Neonatal asphyxia LLT
    12 10028923 Neonatal asphyxia PT
    12 10028946 Neonatal hypoxia and asphyxia HLT
    12 10050081 Neonatal hypoxia LLT
    12 10050081 Neonatal hypoxia PT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    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: 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: 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: 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
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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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