Trial design and oversight
The PICnIC trial was an open-label multicentre RCT in infants and children admitted to one of six participating PICUs (Birmingham, Bristol, Cambridge, John Radcliffe Hospital Oxford, Southampton and St George’s University Hospital London) and an integrated mixed methods study. Sites were selected for geographical spread across England with common configurations for UK PICUs, including a mix of general and cardiac critical care cases within academic, general and standalone children’s hospital settings.The trial was co-ordinated by the Intensive Care National Audit & Research Centre (ICNARC) Clinical Trials Unit (CTU), and the overall study sponsored by the University of Cambridge and Cambridge University Hospital Biomedical Research Centre.The study was approved by the Health Research Authority (IRAS number: 239324) and registered on the ClinicalTrials.gov database (ISRCTN40310490) and all methods were performed in accordance with the approved study protocol. The full study protocol has been previously published, see also Supplementary data