Outcome measures and sample size estimation
RECRUITMENT
As a feasibility study to test whether the protocol could identify and recruit eligible patients, no primary outcome was selected to compare standard care and intervention groups. Instead, sample size was determined by the number needed to test critical parameters to a necessary degree of precision. Based on available data from the national Paediatric Intensive Care Audit Network (PICANet), it was anticipated that the participating sites would screen approximately 4.5 eligible children per week, therefore the anticipated recruitment rate was 3 children per PICU per week providing a total of approximately 324 children in 18 weeks, of which 90 would receive the intervention.