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

Periodic Reporting for period 6 - ALBINO (Effect of ALlopurinol in addition to hypothermia for hypoxic-ischemic Brain Injury on Neurocognitive Outcome)

Reporting period: 2023-01-01 to 2024-06-30

Neonatal hypoxic-ischemic encephalopathy (HIE), i.e. brain injury following insufficient oxygen supply during delivery, 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.
Temporary cooling of the baby’s body to 33.5°C (“therapeutic hypothermia”) became the only established therapy to improve outcome after perinatal brain injury caused by oxygen deficiency. Despite cooling and neonatal intensive care, 40-50% of affected children still die or suffer from long-term neurodevelopmental impairment (i.e. cerebral palsy (severe movement difficulties which are caused when the parts of the brain which control such movements do not work properly), cognitive deficits, and seizures). Additional neuroprotective interventions, i.e. interventions seeking to protect the brain from this injury, besides temporary cooling, are warranted to further improve their outcome.

The ALBINO project seeks to test such an additional neuroprotective intervention. The overall objective is to evaluate whether early postnatal administration of allopurinol in newborns with biochemical and clinical signs of insufficient oxygen supply during delivery, in addition to standard of care (including therapeutic cooling if indicated) reduces the rate of death or severe neurodevelopmental impairment.
If tested successfully, the project also seeks to develop a medication for newborn babies and to make allopurinol available for intravenous administration in children for the European market. Eventually, the project can make an important contribution to alleviate the burden of cerebral palsy and cognitive disability for children, parents and society.
Up to the end of reporting period 6 (ending on 30 June, 2024) both the ALBINO clinical trial and the project as a whole made further progress. Ongoing activities in overall project man-agement (Work Package 1) and study medication logistics (Work Package 2) ran as accompa-nying measures for a smooth conduct of the clinical study and the project in general. Being a large multi-country, multi-centre study, trial coordination efforts remained high, both at cen-tral and national levels (Work Package 3), as crucial study documents, including the Study Protocol and the Investigator’s Brochure (IB) had to be updated and submitted for approvals in all countries that have been active in recruitment. Monitoring activities (Work Package 4) were still dedicated to day-to-day business and to train new national monitors, but also gradu-ally shifted towards study closure activities during reporting period 6 (with one year of project duration remaining). The number of recruited patients enrolled in the clinical study increased from 396 to 504 (Work Package 5). Work on assessment of MRI and EEG imaging data (Work Packages 6 and 7) continued with increased intensity during period 6, with constantly growing datasets of scored MRI and EEG files. The core tasks of WP8 (Pharmacokinetics) were completed during the previous report, but further scientific research was done during this reporting period. Activities in WP9 (Pharmacovigilance) focused on obligatory safety report-ing to regulatory authorities. One highlight in WP10 (Dissemination and Communication) dur-ing the reporting period was the presentation of the ALBINO-Project at a multi-stakeholder event on perinatal asphyxia hosted by another EU-funded action.
If the recruitment goals of the clinical trial can be achieved and the outcomes confirm the hypothesis that Allopurinol proves a viable additional treatment option in addition to hypothermia, the project has the potential to:

- establish safety and efficacy of a novel treatment for infants with brain injury caused by oxygen deficiency complementing current standard of care and (potentially) rendering it more effective
- reduce the burden of brain injury caused by oxygen deficiency for affected children, families and society
- test and validate early indicators (so-called ‘biomarkers’) of later disability, including advanced imaging techniques in a large population of exposed infants
- provide data on the metabolism and excretion allopurinol and mannitol under normal body temperature and during cooling.
- enable a small/medium-size enterprise to grow and eventually to secure jobs or even create new jobs in Europe
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