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Clinical trials for Neonatal Hypoxic Ischemic Encephalopathy

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   44334   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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    12 result(s) found for: Neonatal Hypoxic Ischemic Encephalopathy. 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: 2011-005696-17 Sponsor Protocol Number: 1645-CI-058 Start Date*: 2013-06-18
    Sponsor Name:Instituto de Investigacion Sanitaria La Fe
    Full Title: Multicenter, randomized, blinded clinical study comparing early use of total body moderate hypothermia plus topiramate or placebo in asphyxiated newborn infants evolving to moderate-to-severe hypox...
    Medical condition: Asphyxiated newborn infants evolving to moderate-to-severe hypoxic ischemic encephalopathy
    Disease:
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    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: 2016-000936-17 Sponsor Protocol Number: GWEP1560 Start Date*: 2019-07-23
    Sponsor Name:GW Research Ltd
    Full Title: A Randomized, Double-Blind, Placebo-Controlled Single-Ascending Dose Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of GWP42003-P in Conjunction with Hypothermia in Neonates with ...
    Medical condition: Neonatal Hypoxic-Ischemic Encephalopathy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10070512 Hypoxic-ischemic encephalopathy LLT
    20.0 10038738 - Respiratory, thoracic and mediastinal disorders 10050081 Neonatal hypoxia PT
    Population Age: Preterm newborn infants, Newborns, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-020797-41 Sponsor Protocol Number: NEMO1-08NR26 Start Date*: 2010-11-16
    Sponsor Name:Only for Children Pharmaceuticals
    Full Title: NEMO-1: An open label exploratory dose finding and pharmacokinetic clinical trial of bumetanide for the treatment of NEonatal seizure using Medication Off-patent.
    Medical condition: Neonatal Seizures in Hypoxic Ischemic Encephalopathy
    Disease: Version SOC Term Classification Code Term Level
    15.0 10029205 - Nervous system disorders 10061197 Neonatal seizures LLT
    Population Age: Newborns, Under 18 Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) FI (Prematurely Ended) GB (Prematurely Ended) SE (Prematurely Ended) FR (Ongoing) NL (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2014-001826-13 Sponsor Protocol Number: 200721 Start Date*: 2015-02-16
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Randomized, Double-blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban Therapy for Women in Spontaneous Preterm Labor
    Medical condition: preterm labor
    Disease: Version SOC Term Classification Code Term Level
    19.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036595 Premature delivery PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: BE (Completed) GB (Completed) SE (Completed) ES (Completed) DE (Completed) IT (Prematurely Ended) FR (Completed)
    Trial results: View results
    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: 2018-000770-29 Sponsor Protocol Number: Ireland-RctV8 Start Date*: 2018-06-18
    Sponsor Name:The Rotunda Hospital
    Full Title: Investigating the role of early low-dose aspirin in diabetes: A phase III multicentre double-blinded placebo-controlled randomised trial of low-dose aspirin initiated in the first trimester of diab...
    Medical condition: Pregestational type I or type II diabetes
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004861 10045228 Type I diabetes mellitus LLT
    21.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults Gender: Female
    Trial protocol: IE (Prematurely Ended)
    Trial results: View results
    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: 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: 2014-003326-41 Sponsor Protocol Number: 200719 Start Date*: 2016-01-13
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Randomized, Double-Blind, Multicenter, Phase III Study Comparing the Efficacy and Safety of Retosiban Versus Placebo for Women in Spontaneous Preterm Labor
    Medical condition: Preterm Labour
    Disease: Version SOC Term Classification Code Term Level
    19.1 10036585 - Pregnancy, puerperium and perinatal conditions 10036600 Premature labour PT
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: GB (Completed) IT (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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