Kim Annink

178 Chapter 8 requiring neonatal surgery or affecting long-term outcome. Furthermore, infants will be excluded if their postnatal age is > 30 minutes at the end of the screening phase, the neonate is considered “moribund” or “non-viable”, there is a decision of ‘comfort care only’ before study drug administration or if parents decline study participation. Randomization and allocation concealment Randomization will be performed with randomization software (Randlist Version 1.2) in blocks of four and stratified per center. Randomization will be performed by allocation of the next consecutive study medication box (including first and second vial of study medication and two vials with sterile water for reconstitution) to an infant. Study Intervention Infants included in the ALBINO trial will receive either allopurinol or placebo (mannitol). Study medication will be administered by intravenous infusion in one or two doses (see Figure 1). The first dose (20 mg/kg body mass reconstituted in 2 ml/ kg sterile water for infusion) will be given as soon as possible after birth. The start of infusion of study medication should preferably be within 30 minutes after birth, but no later than 45 min after birth. The second dose (10mg/kg body mass reconstituted in 1 ml/kg sterile water for infusion) will be administered 12 hours after the first dose. This second dose will only be administered to infants treated with therapeutic hypothermia. Infants who recover quickly and do not qualify for and hence do not undergo hypothermia will not receive a second dose. Placebo (mannitol) will be given in the same dose, volume and intervals as allopurinol. Concomitant interventions and medication: Any concomitant medication that is medically necessary for the patients will be allowed in the study, except open-label allopurinol in any dosage and any application mode. Where indicated according to respective national standards or treatment protocols, hypothermia treatment (whole body cooling to 33.5°C for 72 hours) should be started as soon as possible according to local protocols (3,27).