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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.

Field of science

  • /medical and health sciences/clinical medicine/radiology/medical imaging/magnetic resonance imaging
  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmacokinetics
  • /social sciences/sociology/demography/fertility
  • /natural sciences/biological sciences/biochemistry

Call for proposal

H2020-PHC-2015-two-stage
See other projects for this call

Funding Scheme

RIA - Research and Innovation action

Coordinator

EBERHARD KARLS UNIVERSITAET TUEBINGEN
Address
Geschwister-scholl-platz
72074 Tuebingen
Germany
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 2 029 252,61

Participants (15)

TECHNISCHE UNIVERSITAET DRESDEN
Germany
EU contribution
€ 171 756
Address
Helmholtzstrasse 10
01069 Dresden
Activity type
Higher or Secondary Education Establishments
UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Netherlands
EU contribution
€ 637 735,29
Address
Heidelberglaan 100
3584 CX Utrecht
Activity type
Higher or Secondary Education Establishments
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 210 313,25
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
UNIVERSITAT ZURICH
Switzerland
EU contribution
€ 0
Address
Ramistrasse 71
8006 Zurich
Activity type
Higher or Secondary Education Establishments
MEDIZINISCHE UNIVERSITAET WIEN
Austria
EU contribution
€ 136 384,25
Address
Spitalgasse 23
1090 Wien
Activity type
Higher or Secondary Education Establishments
FUNDACION PARA LA INVESTIGACION DEL HOSPITAL UNIVERSITARIO LA FE DE LA COMUNIDAD VALENCIANA
Spain
EU contribution
€ 233 464,38
Address
Av Fernando Abril Martorell 106
46026 Valencia
Activity type
Research Organisations
UNIVERSIDADE DO PORTO
Portugal
EU contribution
€ 143 842,25
Address
Praca Gomes Teixeira
4099 002 Porto
Activity type
Higher or Secondary Education Establishments
OSLO UNIVERSITETSSYKEHUS HF
Norway
EU contribution
€ 207 489
Address
Kirkeveien 166 Tarnbygget
0450 Oslo
Activity type
Higher or Secondary Education Establishments
UNIVERSITA DEGLI STUDI DI UDINE
Italy
EU contribution
€ 196 432,75
Address
Via Palladio 8
33100 Udine
Activity type
Higher or Secondary Education Establishments
HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ
Finland
EU contribution
€ 179 550,50
Address
Stenbackinkatu 9
00029 Helsinki
Activity type
Research Organisations
HELSINGIN YLIOPISTO
Finland
EU contribution
€ 127 875
Address
Yliopistonkatu 3
00014 Helsingin Yliopisto
Activity type
Higher or Secondary Education Establishments
OSTRAVSKA UNIVERZITA

Participation ended

Czechia
EU contribution
€ 395,89
Address
Dvorakova 7
701 03 Ostrava
Activity type
Higher or Secondary Education Establishments
UNIWERSYTET MEDYCZNY IM KAROLA MARCINKOWSKIEGO W POZNANIU
Poland
EU contribution
€ 159 576,33
Address
Ul. Fredry 10
61-701 Poznan
Activity type
Higher or Secondary Education Establishments
TARTU ULIKOOL
Estonia
EU contribution
€ 98 426,25
Address
Ulikooli 18
51005 Tartu
Activity type
Higher or Secondary Education Establishments
ACE PHARMACEUTICALS BV
Netherlands
EU contribution
€ 1 461 536,25
Address
Schepenveld 41
3891 ZK Zeewolde
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)