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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.
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Coordinator

EBERHARD KARLS UNIVERSITAET TUEBINGEN

Address

Geschwister-Scholl-Platz
72074 Tuebingen

Germany

Activity type

Higher or Secondary Education Establishments

EU Contribution

€ 2 032 277,61

Participants (15)

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TECHNISCHE UNIVERSITAET DRESDEN

Germany

EU Contribution

€ 171 756

UNIVERSITAIR MEDISCH CENTRUM UTRECHT

Netherlands

EU Contribution

€ 634 710,29

KATHOLIEKE UNIVERSITEIT LEUVEN

Belgium

EU Contribution

€ 210 313,25

UNIVERSITAT ZURICH

Switzerland

MEDIZINISCHE UNIVERSITAET WIEN

Austria

EU Contribution

€ 136 384,25

FUNDACION PARA LA INVESTIGACION DEL HOSPITAL UNIVERSITARIO LA FE DE LA COMUNIDAD VALENCIANA

Spain

EU Contribution

€ 233 464,38

UNIVERSIDADE DO PORTO

Portugal

EU Contribution

€ 143 842,25

OSLO UNIVERSITETSSYKEHUS HF

Norway

EU Contribution

€ 207 489

UNIVERSITA DEGLI STUDI DI UDINE

Italy

EU Contribution

€ 196 432,75

HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ

Finland

EU Contribution

€ 179 550,50

HELSINGIN YLIOPISTO

Finland

EU Contribution

€ 127 875

OSTRAVSKA UNIVERZITA

Czechia

EU Contribution

€ 395,89

UNIWERSYTET MEDYCZNY IM KAROLA MARCINKOWSKIEGO W POZNANIU

Poland

EU Contribution

€ 159 576,33

TARTU ULIKOOL

Estonia

EU Contribution

€ 98 426,25

ACE PHARMACEUTICALS BV

Netherlands

EU Contribution

€ 1 461 536,25

Project information

Grant agreement ID: 667224

Status

Ongoing project

  • Start date

    1 January 2016

  • End date

    31 December 2020

Funded under:

H2020-EU.3.1.3.

  • Overall budget:

    € 6 307 599,50

  • EU contribution

    € 5 994 030

Coordinated by:

EBERHARD KARLS UNIVERSITAET TUEBINGEN

Germany