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Effect of ALlopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome

Objective

Neonatal hypoxic-ischemic encephalopathy (HIE) is a major cause of death or long-term disability in infants born at term in the western world, affecting about 1-4 per 1.000 life births and consequently about 5-20.000 infants per year in Europe.
Hypothermic treatment became the only established therapy to improve outcome after perinatal hypoxic-ischemic insults. Despite hypothermia and neonatal intensive care, 45-50% of affected children die or suffer from long-term neurodevelopmental impairment. Additional neuroprotective interventions, beside hypothermia, are warranted to further improve their outcome.
Allopurinol is a xanthine oxidase inhibitor and reduces the production of oxygen radicals and brain damage in experimental, animal, and early human studies of ischemia and reperfusion.
This project aims to evaluate the efficacy and safety of allopurinol administered immediately after birth to near-term infants with HIE in addition to hypothermic treatment.
Beyond this primary objective, the project will provide information on the effect of hypothermia on pharmacokinetics of drugs with a similar metabolism as allopurinol in neonates. Furthermore it will give the opportunity to further develop and validate biomarkers for neonatal brain injury using advanced magnetic resonance imaging, biochemistry, and electroencephalogramms, which will then be available for future studies testing neuroprotective interventions. Finally, this trial will extend our knowledge about incidence of and risk factors for perinatal asphyxia and HIE possibly enabling generation of more preventive strategies for the future.

Call for proposal

H2020-PHC-2014-2015

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Sub call

H2020-PHC-2015-two-stage

Coordinator

EBERHARD KARLS UNIVERSITAET TUEBINGEN
Net EU contribution
€ 1 946 061,11
Address
Geschwister-scholl-platz
72074 Tuebingen
Germany

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Region
Baden-Württemberg Tübingen Tübingen, Landkreis
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,14

Participants (17)

Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

Universitaetsklinikum Tuebingen
Germany
Net EU contribution
€ 11 004,00
Address
Geissweg 3
72076 Tuebingen

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Region
Baden-Württemberg Tübingen Tübingen, Landkreis
Activity type
Research Organisations
Non-EU contribution
€ 0,00
TECHNISCHE UNIVERSITAET DRESDEN
Germany
Net EU contribution
€ 171 756,00
Address
Helmholtzstrasse 10
01069 Dresden

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Region
Sachsen Dresden Dresden, Kreisfreie Stadt
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Netherlands
Net EU contribution
€ 666 360,29
Address
Heidelberglaan 100
3584 CX Utrecht

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Region
West-Nederland Utrecht Utrecht
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
Net EU contribution
€ 210 313,25
Address
Oude Markt 13
3000 Leuven

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Region
Vlaams Gewest Prov. Vlaams-Brabant Arr. Leuven
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
UNIVERSITAT ZURICH
Switzerland
Net EU contribution
€ 0,00
Address
Ramistrasse 71
8006 Zurich

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Region
Schweiz/Suisse/Svizzera Zürich Zürich
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 313 569,25
MEDIZINISCHE UNIVERSITAET WIEN
Austria
Net EU contribution
€ 136 384,25
Address
Spitalgasse 23
1090 Wien

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Region
Wien Wien
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
FUNDACION PARA LA INVESTIGACION DEL HOSPITAL UNIVERSITARIO LA FE DE LA COMUNIDAD VALENCIANA
Spain
Net EU contribution
€ 270 026,88
Address
Av Fernando Abril Martorell 106
46026 Valencia

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Region
Este Comunitat Valenciana Valencia/València
Activity type
Research Organisations
Non-EU contribution
€ 0,00
UNIVERSIDADE DO PORTO
Portugal
Net EU contribution
€ 143 842,25
Address
Praca Gomes Teixeira
4099-002 Porto

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Region
Continente Norte Área Metropolitana do Porto
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
OSLO UNIVERSITETSSYKEHUS HF
Norway
Net EU contribution
€ 207 489,00
Address
Kirkeveien 166 Tarnbygget
0450 Oslo

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Region
Norge Oslo og Viken Oslo
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
UNIVERSITA DEGLI STUDI DI UDINE
Italy
Net EU contribution
€ 180 769,00
Address
Via Palladio 8
33100 Udine

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Region
Nord-Est Friuli-Venezia Giulia Udine
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
Third-party

Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.

AZIENDA SANITARIA UNIVERSITARIA FRIULI CENTRALE
Italy
Net EU contribution
€ 22 663,75
Address
Via Pozzuolo 330
33100 Udine

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Region
Nord-Est Friuli-Venezia Giulia Udine
Activity type
Research Organisations
Non-EU contribution
€ 0,00
HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ
Finland
Net EU contribution
€ 179 550,50
Address
Stenbackinkatu 9
00029 Helsinki

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Region
Manner-Suomi Helsinki-Uusimaa Helsinki-Uusimaa
Activity type
Research Organisations
Non-EU contribution
€ 0,00
HELSINGIN YLIOPISTO
Finland
Net EU contribution
€ 127 875,00
Address
Yliopistonkatu 3
00014 Helsingin Yliopisto

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Region
Manner-Suomi Helsinki-Uusimaa Helsinki-Uusimaa
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
OSTRAVSKA UNIVERZITA

Participation ended

Czechia
Net EU contribution
€ 395,89
Address
Dvorakova 7
701 03 Ostrava

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Region
Moravskoslezsko Moravskoslezský kraj
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
UNIWERSYTET MEDYCZNY IM KAROLA MARCINKOWSKIEGO W POZNANIU
Poland
Net EU contribution
€ 159 576,33
Address
Ul. Fredry 10
61-701 Poznan

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Region
Makroregion północno-zachodni Wielkopolskie Miasto Poznań
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,11
TARTU ULIKOOL
Estonia
Net EU contribution
€ 98 426,25
Address
Ulikooli 18
51005 Tartu

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Eesti Eesti Lõuna-Eesti
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
ACE PHARMACEUTICALS BV
Netherlands
Net EU contribution
€ 1 461 536,25
Address
Schepenveld 41
3891 ZK Zeewolde

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SME

The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.

Yes
Region
Oost-Nederland Flevoland Flevoland
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00