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).
Study Update – November 2023 – Click Here
Study Update – May 2024
“Working on the NI-PoV study TREOCAPA was a challenge, sometimes difficult but very enjoyable. We were very pleased to work in a European Network, overcome our differences and sometimes some obstacles and achieve our goal to all: recruit more than 800 preterm infants in the allotted time. We, as the TREOCAPA coordination team, are very happy with this success. We appreciate the efforts of everyone, many thanks to our big brilliant team composed of more than 500 collaborators, including all the investigators from 14 countries, the INSERM Pedstart and c4c coordination team, the data management team “UPCET France”, the Safety team from “INSERM and ANRS France”, all the c4c National Hubs , the CTUs, ECRIN ….. Without everyone, we would not have been able to reach this height.”
Parent Video on experiences with the TREOCAPA study:
How does it feel like for parents to take part in a clinical trial with their newborn baby? Thanks to four families who took part in the TREOCAPA study and have shared their experiences with us, we can now gain an insight into this challenging situation. In this video, you can learn more about:
- the experiences of the participating families with the TREOCAPA study
- if the parents would recommend other families and their babies to take part in a neonatal clinical trial, and if so, why?
- the scientific value of the TREOCAPA study according to the participating families
- next steps or follow-up actions that participating families would like to see once the TREOCAPA results are published and the trial is completed
We thank all the parents and families who shared their very valuable experiences with us in these videos! Together we can improve neonatal care and advance medicine in the field of neonatology.
Watch the video here: TREOCAPA’s Interview: Some experiences of parents’ participants – TREOCAPA
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