Overview of the Fluids in Shock (FiSh) and Fever feasibility study designs
| FiSh | Fever study | |
| Aims | To establish the feasibility of conducting a randomised controlled trial comparing restrictive fluid bolus therapy (10 mL/kg) with the current UK recommended practice (20 mL/kg). | To establish the feasibility of conducting a definitive trial comparing temperature thresholds at which staff deliver antipyretic intervention in critically ill children with fever due to infection (intervention treat at ≥39.5°C, standard care treat at >37.5°C). |
| Feasibility study elements | (1) Qualitative study exploring parent views. (2) Nine-month pilot trial with integrated parent and staff perspectives study. | (1) Qualitative study exploring parent and clinician views. (2) Observational study of the epidemiology of fever in children with infection in paediatric intensive care unit. (3) Four-month pilot trial with integrated parent and staff perspectives study. |
| Pilot trial participants | Children (age >37 weeks (corrected gestational age) and <16 years) admitted to an emergency department with clinical suspicion of infection and signs of shock after receipt of 20 mL/kg of bolus fluid. | Children (age >29 days and <16 years) admitted to intensive care with a fever (≥37.5°C) in the first 48 hours and suspected infection who require mechanical ventilation. |