Aim of the study

What is the ductus arteriosus?

The Ductus Arteriosus is present in all babies before birth and normally closes in the days following birth. However, in about 60% of preterm born babies (born before the completion of 37 weeks of pregnancy), this blood vessel remains open. This is most often the case in the more premature ones. If this vessel does not close, babies often experience more complications of prematurity with the lungs, brain, and gut than babies, in which this vessel does close.

Why is paracetamol the drug of choice?

Certain drugs (indomethacin or ibuprofen) that can be used to close
the ductus arteriosus have many adverse effects. Recently, it has been shown that prophylactic (preventative) use of paracetamol, a drug with far fewer side effects, can also close the ductus arteriosus. This drug is widely used in neonatology (the care of newborns, especially preterm and ill babies) against pain.

How is the study structured an where does it take place?

The TREOCAPA study has two parts: Phase II and Phase III.

The aim of Phase II of this study is to find the minimum dose of paracetamol that closes the ductus arteriosus before or at day 7
after birth in preterm infants born at a gestational age of 23 to 26 weeks. Phase II of this study will be conducted in 10 centres of
4 European countries. A total of 30 preterm babies will be included over a period of 6 months.

The Phase III of this trial will investigate whether the prophylactic use of paracetamol in preterm babies during their first five days of life is safe and effective in reducing risk of death or severe complications of prematurity, like brain bleedings, pulmonary lesions or eye problems, by preventing a persistent ductus arteriosus. Additionally, the influence of paracetamol on pain and on the use of pain killers as well as long-term effects of paracetamol are currently being investigated. The trial will be conducted in more than 60 centres of 17 European countries. A total of 794 preterm babies will be included over a period of 28 months.

How long will the study last?

The entire TREOCAPA trial (Phase II and III) will last 38 months in total.