SPIRIT-Children and Adolescents (SPIRIT-C) 2026 extension statement: enhancing the reporting and usefulness of paediatric randomised trial protocols

Randomised controlled trial (RCT) protocols contain essential details needed to understand and evaluate the trial’s planned aims, design, data collection methods, monitoring, data analysis, and participants’ safety. However, key information is often omitted from paediatric RCT protocols, including details on dose adjustments of interventions based on age, body surface area, or weight, developmental appropriateness of trial outcome measures and processes, or strategies to minimise participants’ anxiety and pain. These deficiencies impair the planning and implementation of potentially impactful trials for children and adolescents. Appropriate guidance is needed to support harmonised, comprehensive reporting of…