The trial is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Sixty neonatal intensive care units across 16 countries will be randomising 3000 newborns in total. The trial protocol is in agreement with the SPIRIT guidelines (Table ) (Additional file 1) [12].
Schedule for enrolment, intervention and assessment, based on the SPIRIT 2013 guidance for protocols of clinical trials. Asterisk symbol (*) indicates the following: if approved by the local ethics committee, deferred informed consent or prior informed assent may be sought. Time to ask parents for deferred consent will be decided individually by clinical staff members
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