Table 3

Time schedule for participants in the PARASHUTE study 

VisitScreeningBaseline
(first liver biomarkers)
Steady stateOpportunistic samplingMeasurements after treatment stopIf the patient receives intravenous or oral phenobarbital
TimeframeBefore treatment start or within 24 hours18–36 hours after treatment start or as close to as possible24 hoursMaximum 24 hours after phenobarbital is administered
EligibilityInformed consentx
Inclusion and exclusion criteriaxx
Information to parentsxx
Other measurementsOther medicinex*x*xx
Assessment of serious adverse eventsxxx
Weight and lengthx*x*xx
Effect parametersHepatic biomarkers (ALT, coagulation factors†, bilirubin)x‡xx
P-paracetamol and metabolitesxxx
Secondary parametersP-ethanolx
COMFORT neo scores
  • *Joint values.

  • †In case of ALT increase ≥three times UNL according to age, coagulation factors are measured.

  • ‡Not necessary if liver biomarkers have been measured within 24 hours before inclusion. The biomarkers should preferably be taken before treatment start, if this is not possible a 24 hours delay is accepted, and they are then classified as ‘first liver biomarkers’.

  • §Measured at normal routines timepoints at the two sites.

  • ALT, alanine aminotransferase.