Frequently asked questions by parents for recruitment in the TREOCAPA study
In the course of the study, your baby will receive several infusions with Paracetamol through a central venous line that is already set up for the routine care of your baby. The set-up of the central venous line may cause a slight pain at the site of the puncture. Your baby will not have additional pain by participating in the study.
In undertaking a clinical trial, researchers do not want to leave anything to chance. They want to be as certain as possible that the results of the testing show if a treatment is safe and effective. Comparing results from two groups – treatment and placebo group – suggests whether changes in the test group result from the treatment or occur by chance or if indeed the treatment, in this case, paracetamol, is effective. Thereby, the treatment and placebo groups are equally important.
Neither you nor the study team will know which treatment your baby receives (this is called double-blind). This is to make sure the results of each group being studied are handled in the same way. The benefit of enrolling your child in the study is that the very controlled environment of a clinical study leads to additional, more intensive check-ups for your baby. In addition, preventive strategies for the closure of the ductus arteriosus may be improved and may help other babies in the future.
3. I do not want that my child receives a placebo. Can I influence in which group my child is participating?
You cannot decide or influence in which group your child is participating. A computer will be used to assign study participants into treatment groups by chance. This is called randomisation and can be compared to drawing lots. Your baby has a 1 in 2 chance of being placed in either group. Neither you nor the study team will know which treatment your baby receives (this is called double-blind) to make sure the results of each group being studied are handled in the same way.