Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome
Status:
Recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
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.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital Tuebingen
Collaborators:
ACE Pharmaceuticals BV Fundación para la Investigación del Hospital Clínico de Valencia Helsingin Ja Uudenmaan Sairaanhoitopiirin Helsinki University Katholieke Universiteit Leuven KU Leuven Oslo University Hospital Poznan University of Medical Sciences Tartu University Hospital Technische Universität Dresden UMC Utrecht Universidade do Porto Università degli Studi di Udine University Hospital Ostrava University of Helsinki University of Vienna University of Zurich