Study procedure

When will the participants be enrolled?

Study enrolment and the first administration of either paracetamol or placebo must be given intravenously within the first 12 hours after birth.

Which interventions are the participants receiving?

During the first 5 days of life, further intravenous infusions will follow at 6-hourly intervals for 15 minutes each (total of 20 doses). For the safety of the baby, after the 1st and after 10th injection of paracetamol, a supplementary blood sample (0.1 to 0.3mL, depending on the local practices) will be taken during routine care to measure the level of markers to determine how well the liver is working.

Which additional interventions are performed?

In addition to the intravenous infusions (placing fluids into the bloodstream through a vein), three time points are particularly important during the TREOCAPA trial: on the 7th day of life, an ultrasound of the heart will be performed. On the 7th and on the 28th day of life and what would have been week 36 of pregnancy (postmenstrual age) or at discharge, medical data will be collected.