Prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen.

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). The study is Sponsored and coordinated by INSERM, a public research organization in Paris, France.

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.

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).

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• Link to official website: https://www.clinicaltrialsregister.eu/ctr-search/search?query=treocapa

• Link to Trial website: https://treocapa.inserm.fr/