Study procedure

When does the actual intervention start?

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

What further treatments do the babies receive?

During the first 5 days of life, further intravenous infusions (placing fluids into the bloodstream through a vein) will follow at
6-hourly intervals for 15 minutes each (total of 20 doses).

What other medical procedures are involved?

For the safety of the baby, after the 1st and 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.

How will the baby be monitored?

In addition to the intravenous infusions, the baby will be closely monitored during the TREOCAPA trial: the blood pressure of
the baby will be measured at 30, 60, 90 and 120 minutes after each infusion, and an ultrasound of the heart is done every day.
Blood samples will be taken after dose 1, 10 and 20 to analyse paracetamol concentration in the blood. On the 3rd, 5th and on the
7th day of life and what would have been week 36 of pregnancy (postmenstrual age) or at discharge, medical data will be collected.