Does antenatal allopurinol during asphyxia reduce post-hypoxic-ischemic reperfusion damage in the newborn?

INTERVENTION: Trade Name: Acepurin Pharmaceutical Form: Intravenous infusion INN or Proposed INN: ALLOPURINOL CAS Number: 315300 Other descriptive name: Acepurin Concentration unit: g gram(s) Concentration type: equal Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous use CONDITION: Perinatal asphyxia ; MedDRA version: 9.1 Level: LLT Classification code 10004943 Term: Birth asphyxia ; MedDRA version: 9.1 Level: LLT Classification code 10014633 Term: Encephalopathy neonatal PRIMARY OUTCOME: Main Objective: Fetuses with hypoxic‐ischemia whose mothers are subsequently prenatally treated with 500 mg (iv) allopurinol will have a reduction in free radical‐induced post‐asphyxial reperfusion damage of brain and heart. Furthermore, they will have a better neurological outcome as compared to placebo‐treated neonates. Primary end point(s): Allopurinol treated infants will have less free radical production and lower values of markers of neuronal damage compared to placebo treated infants. Secondary Objective: INCLUSION CRITERIA: INCLUSION CRITERIA: • Gestational age of 36 weeks or more, determined by maternal dates and/or Ballard score. • Objective fetal hypoxia registered by: ? Abnormalities on STAN S21 fetal electrocardiography monitor (Neoventa Medical, Gothenborg, Sweden). OR ? Two or more suboptimal CTG recordings (according to CTG‐classification) OR ? An abnormal / preterminal CTG recording (according to CTG‐classification, see page 10) OR ? Fetal blood sampling: pH<7.20 Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range