Kim Annink

180 Chapter 8 Further important secondary outcome parameters are brain injury assessed by MRI of the brain, cerebral ultrasound, amplitude-integrated EEG, full scale multichannel EEG, heart function assessed by echocardiography, concentrations of peroxidation products and S100B which are markers for brain injury in the blood. Furthermore, pharmacokinetics of allopurinol will be investigated in 48 to 52 patients. Finally, the opinions of parents experiencing two different consent procedures will be evaluated. Parental perspectives Following study participation, parents will be approached again and asked for their opinion on and satisfaction with the consent procedure to inform future investigators in the field of HIE therapy. Ethical Considerations Because allopurinol has to be administered as early as possible after birth to reduce formation of oxygen radicals during reperfusion and because the emergency situation of perinatal asphyxia is very stressful for the parents, the usual procedure of provision of comprehensive oral and written information, time for consideration and full written informed parental consent before study entry is not feasible in the setting of ALBINO. This problem and the various alternative approaches (antenatal consent, short information and oral consent and later full information and written confirmation, waiver of consent for first dose and deferred information and consent), have been discussed with external experts on perinatal HIE as well as medical ethicists and a balance between the need to inform the parents and the feasibility of the study was sought in collaboration with the relevant ethics committees in each participating country. Community Engagement Information material, such as posters and flyers, that provides short information for parents, will be available in prenatal clinics and delivery areas and will direct interested parents to the study home page (www.albino-study.eu) . The homepage will grant access to nationally approved full parent information material. A press release will inform the community around study sites about the ALBINO trial. Parents, who do not want to participate in the ALBINO trial, will have the option to deny participation even before delivery verbally or on a ‘declaration of intent’-form