Additional consent provisions for collection and use of participant data and biological specimens {26b}
Parents/legal guardians give consent for the collection and analysis of data to study the safety and efficacy of prophylactic LISA treatment. This includes the use of data for regulatory purposes and ancillary analyses (e.g. meta-analyses). All sites of the pro.LISA trial are part of the German Neonatal Network (GNN). In the GNN, deoxyribonucleic acid samples of participating children are collected. Parents are asked for separate consent for enrolment in the GNN.