Does antenatal allopurinol during perinatal asphyxia reduce post-hypoxic-ischemic reperfusion damage in the newborn? A double blind randomised placebo controlled multicenter trial.

Hypoxic-ischaemic encephalopathy is associated with development of cerebral
palsy and cognitive disability later in life, and is therefore one of the
fundamental problems in perinatal medicine. The xanthine-oxidase inhibitor
allopurinol reduces the production of free radical formation, thereby limiting
the amount of hypoxia-reperfusion damage. Animal and human studies suggest that
administration of allopurinol immediately prior to delivery in the case of
suspected intra-uterine asphyxia might reduce hypoxic-ischaemic encephalopathy.

In the present proposal, we aim to answer whether antenatal allopurinol
administration does reduce hypoxic-ischaemic encephalopathy in neonates exposed
to intra-uterine asphyxia.

Randomised double blind placebo controlled multicenter study.

Allopurinol or placebo administration antenatally to the mother.

Up to this day no maternal nor neonatal adverse events are being reported after
using a dose of allopurinol as used in our study (i.e. 500 mg i.v.). The risks
for complications due to treatment with allopurinol is very low whereas the
possible benefits of treatment with allopurinol regarding neuronal damage seem
to be reasonable.
Studied newborns shall only be admitted when clinically indicated. Bloodsamples
will only be obtained during clinically indicated blood withdrawls. Therefore
no extra invasive procedures will be necessary.