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ALLO-trial

 

 

Antenatal allopurinol trial for reduction of birth asphyxia induced brain damage

Go to the ALLO-trial website


Objective
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 (ALLO) reduces the production of free radical formation, thereby limiting the amount of hypoxia-reperfusion damage. Animal and human studies suggest that administration of ALLO 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.


Study design
Randomized double blind placebo controlled multicenter study

Study population
W
omen at term in whom the fetus is suspected of intra-uterine asphyxia


Intervention
Allopurinol or placebo administration antenatally to the mother.

 

Outcome measures
Primary outcome measure is severity of oxidative stress and markers of brain damage (S100B) as measured in umbilical cord blood. Secondary outcomes are neonatal mortality and serious composite morbidity.


Power/data analysis
110 patients per group are needed (a total of 220 patients) if based on a reduction in clinical levels of oxidative stress and markers of brain damage of 10%, using a two sided test (alpha 0,05, power of 0.95).


Economic evaluation
As the costs of ALLO and its administration are relatively low, a small treatment effect will already make the intervention cost-effective. We will perform economic modelling, in which we assess at what prevalence of encephalopathy administration of ALLO is cost-effective.

Time schedule
24 months

Projectleaders
Dr.
J.B. Derks, gynaecologist, UMC Utrecht

Dr. M.J.L.N. Benders, neonatologist, UMC Utrecht

 

Projectmembers

Drs. J.J. Kaandorp, PhD student, UMC Utrecht

Dr. C. Rademaker, farmacist, UMC Utrecht

Dr. H.L. Torrance, resident in gynaecology, UMC Utrecht

Prof. Dr. F. van Bel, neonatologist, UMC Utrecht

Prof. Dr, G.H.A. Visser, gynaecologist, UMC Utrecht

 

Subsidy
ZonMW www.ZonMw.nl