Enrolment into neonatal trials: Points to consider during protocol development

This PedCRIN guidance provides practical recommendations for incorporating participant enrolment considerations into the design of neonatal clinical trial protocols. It highlights the importance of planning recruitment strategies at an early stage of protocol development and presents practical approaches to improving enrolment while maintaining ethical standards and participant-centred research practices. The guidance addresses topics such as recruitment planning, identification of eligible participants, communication with parents and families, informed consent procedures, investigator and site preparation, staff training, and organisational factors that may influence recruitment success.

Although developed for neonatal clinical trials, the guidance is highly relevant to paediatric and rare disease research. Many rare disease trials face similar recruitment challenges, including small and geographically dispersed patient populations, limited numbers of specialised centres, complex eligibility criteria and the need to engage patients and families under challenging circumstances. The recommendations provided can therefore be adapted to a wide range of rare disease studies where successful enrolment depends on careful planning, effective communication and close collaboration between investigators, clinical teams and participants.

For trial management, this guidance supports researchers in anticipating recruitment challenges before study initiation and implementing practical strategies that improve enrolment, participant engagement and study feasibility. By encouraging participant-centred recruitment processes and well-prepared study sites, the resource helps strengthen trial implementation and contributes to more efficient delivery of paediatric and rare disease clinical trials. Although developed within the European PedCRIN project, the principles described are broadly applicable to international clinical research and reflect good practice that can be implemented across different healthcare and regulatory settings.