Kim Annink

181 ALBINO trial: study protocol printed on the flyers informing about the study. This can be completed and kept in the maternal health passport to inform the staff in the delivery room. Form of Consent According to the relevant ethics committee’s decisions, either a deferred consent or an initial short oral consent approach will be used for obtaining parental consent. The deferred consent procedure has previously been used in emergency research in adults and is in compliance with §30 of the Declaration of Helsinki (28). In the case that a child fulfills the inclusion criteria and meets no exclusion criterion, physicians will administer the first dose of study medication in the delivery room without prior consent (i.e., a ‘consent waiver’ was granted for the first dose of study medication). Parents will receive detailed information later and will be asked for written informed consent for continued participation in the study (as soon as possible, at the latest before the second dose of study medication if indicated). The deferred consent procedure has been approved in Austria, Belgium, Estonia, Finland and Norway. In Germany, the Netherlands, Italy, Switzerland and Spain, the ethical committees did not agree on the deferred consent procedure, so in these countries the short oral consent procedure will apply: short oral information (duration <5min) on the indication and the potential benefits and risks of the study medication must be provided to at least one parent and oral (or written) consent of this parent must be obtained before the first dose of study medication can be administered. Again, both parents will receive more detailed information and will be asked for full written consent as soon as possible and at the latest before the second dose of study medication will be administered (if indicated). Statistical analysis Sample size, power and study duration The primary assessment for efficacy will compare the proportions of infants surviving without severe NDI versus those of infants who died or survived with severe NDI at the age of two years. Based on the above referenced (preliminary) clinical studies from the pre- therapeutic hypothermia era and clinical studies on hypothermic treatment, it is estimated that the combined incidence of death and severe NDI in the control group 8