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ALBINO SIGNED

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

Total Cost €

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EC-Contrib. €

0

Partnership

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Project "ALBINO" data sheet

The following table provides information about the project.

Coordinator
EBERHARD KARLS UNIVERSITAET TUEBINGEN 

Organization address
address: GESCHWISTER-SCHOLL-PLATZ
city: TUEBINGEN
postcode: 72074
website: www.uni-tuebingen.de

contact info
title: n.a.
name: n.a.
surname: n.a.
function: n.a.
email: n.a.
telephone: n.a.
fax: n.a.

 Coordinator Country Germany [DE]
 Project website http://www.albino-study.eu
 Total cost 6˙307˙599 €
 EC max contribution 5˙994˙030 € (95%)
 Programme 1. H2020-EU.3.1.3. (Treating and managing disease)
 Code Call H2020-PHC-2015-two-stage
 Funding Scheme RIA
 Starting year 2016
 Duration (year-month-day) from 2016-01-01   to  2020-12-31

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    EBERHARD KARLS UNIVERSITAET TUEBINGEN DE (TUEBINGEN) coordinator 2˙029˙252.00
2    ACE PHARMACEUTICALS BV NL (ZEEWOLDE) participant 1˙461˙536.00
3    UNIVERSITAIR MEDISCH CENTRUM UTRECHT NL (UTRECHT) participant 637˙735.00
4    FUNDACION PARA LA INVESTIGACION DEL HOSPITAL UNIVERSITARIO LA FE DE LA COMUNIDAD VALENCIANA ES (VALENCIA) participant 233˙464.00
5    KATHOLIEKE UNIVERSITEIT LEUVEN BE (LEUVEN) participant 210˙313.00
6    OSLO UNIVERSITETSSYKEHUS HF NO (OSLO) participant 207˙489.00
7    UNIVERSITA DEGLI STUDI DI UDINE IT (UDINE) participant 196˙432.00
8    HELSINGIN JA UUDENMAAN SAIRAANHOITOPIIRIN KUNTAYHTYMÄ FI (HELSINKI) participant 179˙550.00
9    TECHNISCHE UNIVERSITAET DRESDEN DE (DRESDEN) participant 171˙756.00
10    UNIWERSYTET MEDYCZNY IM KAROLA MARCINKOWSKIEGO W POZNANIU PL (POZNAN) participant 159˙576.00
11    UNIVERSIDADE DO PORTO PT (PORTO) participant 143˙842.00
12    MEDIZINISCHE UNIVERSITAET WIEN AT (WIEN) participant 136˙384.00
13    HELSINGIN YLIOPISTO FI (HELSINGIN YLIOPISTO) participant 127˙875.00
14    TARTU ULIKOOL EE (TARTU) participant 98˙426.00
15    OSTRAVSKA UNIVERZITA CZ (OSTRAVA) participant 395.00
16    UNIVERSITAT ZURICH CH (ZURICH) participant 0.00

Map

 Project 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.

 Deliverables

List of deliverables.
D10.2 ISRCTN or NCT number Documents, reports 2020-04-07 20:18:38

Take a look to the deliverables list in detail:  detailed list of ALBINO deliverables.

 Publications

year authors and title journal last update
List of publications.
2019 Christian A. Maiwald, Kim V. Annink, Mario Rüdiger, Manon J. N. L. Benders, Frank van Bel, Karel Allegaert, Gunnar Naulaers, Dirk Bassler, Katrin Klebermaß-Schrehof, Maximo Vento, Hercilia Guimarães, Tom Stiris, Luigi Cattarossi, Marjo Metsäranta, Sampsa Vanhatalo, Jan Mazela, Tuuli Metsvaht, Yannique Jacobs, Axel R. Franz
Effect of allopurinol in addition to hypothermia treatment in neonates for hypoxic-ischemic brain injury on neurocognitive outcome (ALBINO): study protocol of a blinded randomized placebo-controlled parallel group multicenter trial for superiority (phase III)
published pages: 210, ISSN: 1471-2431, DOI: 10.1186/s12887-019-1566-8
BMC Pediatrics 19/1 2020-04-07
2018 Kim V. Annink, Axel R. Franz, Jan B. Derks, Mario Rüdiger, Frank van Bel, Manon J.N.L. Benders
Allopurinol: Old Drug, New Indication in Neonates?
published pages: 5935-5942, ISSN: 1381-6128, DOI: 10.2174/1381612823666170918123307
Current Pharmaceutical Design 23/38 2020-04-07

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The information about "ALBINO" are provided by the European Opendata Portal: CORDIS opendata.

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