Kim Annink

179 ALBINO trial: study protocol Figure 1: Study interventions in ALBINO. Primary outcome The primary endpoint will be death or severe NDI versus survival without severe NDI at the age of two years. Severe NDI is hereby defined as any of the following: cognitive or language delay defined as a cognitive-composite-score or a language- composite-score on the Bayley Scales of Infant and Toddler Development (3rd edition) < 85 and/or cerebral palsy (CP) according to the Surveillance of Cerebral Palsy in Europe (SCPE) criteria. Secondary and further outcomes The primary endpoint will be reconstituted as dichotomized composite secondary endpoint (survival without NDI versus death or language-composite-score < 85 or cognitive-composite-score <85 or CP present). Furthermore, the incidences of death and CP and the composite scores derived from the Bayley test (continuous and dichotomized) as well as the Gross Motor Function Classification Score will be analyzed as secondary outcome variables. 8