Potential risks & benefits

Benefits of taking part in the study

The very controlled environment of a clinical study leads to additional, more intensive check-ups for the babies. In addition, preventive strategies for the ductus arteriosus may be improved and may help other babies in the future.

Potential side effetcs

Paracetamol has been approved by many European health authorities for use in preterm babies.
Very rarely, paracetamol may cause harmful side effects, just like any other medication. No side effects have been observed in preterm infants with the specific doses used in the study.

Potential risks

In the course of the study, the baby will receive several infusions with paracetamol through a central venous line that is already set up for the routine care of the baby. The set-up of the central venous line may cause a slight pain at the site of puncture. Several blood samples will be taken from the child throughout the study. Blood collection is always associated with a very low risk. A slight pain may occur at the site of puncture or a bruise may develop, which will disappear after a few days. In very rare cases, a blood clot (thrombosis) may form, there might be localized inflammation or infection at the site of puncture. In extremely rare cases, damage to blood vessels or nerves may occur.