Dissemination plans {31a}
COMPLICATIONS
In general, results from the study will only be published after the database has been closed. Exceptions are publications concerning the design of the study and descriptive results of safety analysis after discharge from the hospital of all enrolled infants. The latter is planned, since the primary endpoint will be measured 5 years after discharge of the last enrolled patient. Since short-term complications might be different between the groups, we are planning descriptive outcome analyses of these data after enrolment is completed.The final report of the trial will be published within a period of 360 days upon completion of the study.