The ALBINO Clinical Trial

Main Goals and Objectives

With this clinical trial, we the ALBINO-Consortium, seek…

to evaluate whether in newborns with asphyxia and early clinical signs of hypoxic ischemic encephalopathy, early postnatal allopurinol compared to placebo administered in addition to standard of care (including therapeutic hypothermia if indicated) reduces the incidence of death or severe neurodevelopmental impairment at 24 months of age;
to evaluate the effect of early postnatal allopurinol (in addition to hypothermia if indicated) on brain injury assessed by magnetic resonance imaging;
to evaluate the safety of allopurinol in neonates treated with hypothermia;
to increase the number of medications appropriately tested and licensed in the newborn population.
to enable preparation of a marketing authorisation application (MAA) of a special allopurinol dosage form for newborns, if allopurinol is proven efficacious to prevent brain injury in newborns with HIE. This will facilitate availability of an allopurinol dosage form for neonates on the European market.

Trial Range and Participation

The ALBINO Clicial Trial will be conducted in 13 European countries. Recruitment in each country will be led by a national coordinating centre which is a partner in the ALBINO-Consortium. Further hospitals will be included as study sites in each participating country. 846 infants are supposed to be included into the trial within a recruitment phase of 48 months.

Expected Impacts

The results of this study should attain and foster impacts towards…

decreasing treatment-related risks in the paediatric population
establishing novel and/or more effective treatment schemes for healthcare in the paediatric population
validating benefits of novel and/or frequently used health interventions in the paediatric population
improving innovation capacity and the integration of new knowledge and strengthening the competitiveness and growth of European companies by developing innovations meeting the needs of European and global markets