What is TREOCAPA?
TREOCAPA is a multicenter trial assessing the effectiveness of paracetamol on the closure of the patent ductus arteriosus in extremely premature babies (23-26 weeks’ gestation), as well as the increase in survival rate without severe morbidity in these babies (for babies born between 23-28 weeks). TREOCAPA will recruit 824 participants acorss 16 European countries.
The study is Sponsored and coordinated by INSERM, a public research organization in Paris, France.
What is a ductus arteriosus?
The ductus arteriosus is a blood vessel in developing babies in the womb, which connects the pulmonary artery to the descending aorta. It allows most of the blood from the right of the heart to by-pass the developing baby’s fluid filled non-functioning lungs. The ductus arteriosus is open in all babies at birth. Its constriction and closure are part of the normal process of a baby’s adaptation to life outside the womb. However, in many extremely premature babies, the ductus arteriosus does not constrict and close after birth. This can lead to the development of patent symptomatic ductus arteriosus (PDA) which is associated with mortality and morbidity. Current medical treatment includes indomethacin, and ibuprofen but several adverse events have been reported with these drugs.
Why is this study needed?
Even though the scientific community is continuing to make progress and new discoveries, premature birth is still a significant cause of infant and child morbidity and mortality. Early treatment with the use of paracetamol is considered by many experts to be an opportunity as an alternative treatment for the closure of PDA to reduce mortality and morbidity in babies and children, without exposure to drugs with more severe adverse effects.
What will the study tell us that is new?
The Phase II of the study will test the use of paracetamol to tell us the minimum dosage in order to close the ductus arteriosus before a baby reaches 7 days old (for babies born between 23-26 weeks of gestational age) and the Phase III of the study will tell us if this increases survival rate without severe morbidity in these babies (for babies born between 23-28 weeks).