Visit | Screening | Baseline | 1. dose | 2. dose | If the patient has a cubital intravenous access |
Timeframe | Before treatment start | See individualised timing of saliva samples | See individualised timing of saliva samples | Same sampling times as the saliva samples | |
Eligibility | |||||
Informed consent | x | ||||
Inclusion and exclusion criteria | x | x | |||
Information to parents | x | x | |||
Other measurements | |||||
Other medicine | X* | X* | x | ||
MPIS/PEWS | X* | X* | x | ||
Assessment of adverse events | x | x | x | ||
Weight | X* | X* | X* | ||
Effect parameters | |||||
Prednisolone concentrations measured in saliva samples | x | x | x | x† | |
Secondary parameters | |||||
Tolerability | x | x |
*Will share the same value or registration.
†Blood samples in addition to saliva samples.
MPIS, Modified Pulmonary Index Score; PEWS, Paediatric Early Warning Score.