Table 3

The table illustrates the different trial activities.

VisitScreeningBaseline1. dose2. doseIf the patient has a cubital intravenous access
TimeframeBefore treatment startSee individualised timing of saliva samplesSee individualised timing of saliva samplesSame sampling times as the saliva samples
Eligibility
 Informed consentx
 Inclusion and exclusion criteriaxx
 Information to parentsxx
Other measurements
 Other medicineX*X*x
 MPIS/PEWSX*X*x
 Assessment of adverse eventsxxx
 WeightX*X*X*
Effect parameters
 Prednisolone concentrations measured in saliva samplesxxxx†
Secondary parameters
 Tolerabilityxx
  • *Will share the same value or registration.

  • †Blood samples in addition to saliva samples.

  • MPIS, Modified Pulmonary Index Score; PEWS, Paediatric Early Warning Score.