Table 1

Objectives and outcomes measures in the PARASHUTE study

Primary objectivePrimary outcome
To explore if long-term (>72 hours) treatment with intravenous or oral paracetamol administered to neonates leads to risk of hepatotoxicity assessed by ALT, bilirubin, paracetamol metabolites and paracetamol concentration.Concentration-time data on plasma paracetamol, paracetamol-sulfate, paracetamol-glucuronide, oxidative metabolites and hepatic biomarkers (ALT, bilirubin) in neonates before, during and after multiple administrations of intravenous or oral paracetamol with focus on long-term (>72 hours) treatment.
Secondary objectiveSecondary outcome
COMFORT neo pain scores
To examine if ethanol-containing drugs (phenobarbital) causes a measurable rise in p-ethanol and if the presence of ethanol interact with paracetamol in neonates.
COMFORT neo pain scores
Levels of paracetamol metabolites and levels of p-ethanol in patients receiving an ethanol-containing drug compared with the patients not receiving an ethanol-containing drug.
  • ALT, alanine aminotransferase.