SaVeBRAIN.Kids-study protocol for a cluster-randomized stepped-wedge trial to reduce hospitalizations for mild traumatic brain injury in children in Germany.

BACKGROUND: Traumatic brain injury (TBI) is one of the most important pediatric conditions worldwide. In Germany, hospitalization rates for mild TBI drastically exceed hospitalization rates from similar healthcare systems. METHODS: The SaVeBRAIN.Kids trial will implement and test a novel care pathway (nCP) for evidence-based standardized risk assessment, structured observation in the emergency department (ED) for several hours, and technology-supported home monitoring with the aim to reduce hospitalizations. This non-inferiority multicenter study will be carried out using a cluster-randomized stepped-wedge design, with all centers starting in the control phase and sequentially transitioning to the intervention. Eligible participants (age ≥ 3 months and < 18 years) must present within 48 h of head injury, have minimal symptoms (Glasgow coma scale ≥ 14), and no risk factors for intracranial complications. The co-primary outcomes are the relative risk of hospitalization and the proportion of unplanned re-visits within 72 h of presentation to the ED for ambulatory cases. Secondary outcomes include clinical safety measures, cost-effectiveness, and process evaluation. Based on power calculations (α = 0.05, power = 0.9), 1390 patients will be recruited over 12 months. DISCUSSION: The SaVeBRAIN.Kids trial addresses a relevant healthcare challenge by testing a new approach to pediatric mild TBI management in Germany. It aligns with current evidence while accounting for the country's specific healthcare context. If successful, the intervention could substantially reduce unnecessary hospitalizations and free inpatient capacities while preserving patient safety. TRIAL REGISTRATION: German Clinical Trials Registry (DRKS00035623). Registered on January 21, 2025.