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Long Term Follow-up of the TREOCAPA Study (TREOCAPA-LT)

Recruitingn/aAges 23 Months - 27 MonthsAllInstitut National de la Santé Et de la Recherche …
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In plain words

What the trial is, and whether it could suit you

The ductus arteriosus (DA) is a large channel connecting the main pulmonary trunk with the descending aorta. In extremely preterm infants, the DA frequently fails to close and this results in a condition called patent ductus arteriosus (PDA). In these patients, PDA has been associated with increased mortality and morbidity in the neonatal period, and neonatal morbidities may in turn be associated with later deficits in cognitive functioning. PDA treatment with COX inhibitors, as ibuprofen or indomethacin, aiming at closing the PDA have been associated with numerous adverse effects and failed to demonstrate significant clinical benefits. Early treatment of PDA with paracetamol (acetaminophen ) has been proposed as an alternative to COX inhibitors. The ongoing pan-European TREOCAPA phase III study (NCT04459117) is a multicentre, double-blind, randomised, placebo-controlled superiority tria

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * were included in the TREOCAPA phase III RCT in participating centres * are aged between 23.5 and 27.5 months corrected age during the study period Exclusion Criteria: * if the local investigator does not have up-to-date contact information allowing contact with parents * if the child's vital status cannot be ascertained * if the child is nearing the end of his life or experiencing a severe medical event as assessed by the local investigator * if the child has become subject to a legal protection measure preventing their ongoing participation in clinical research * if either parent or guardian opts out of participating * language barrier
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What it tests

  • 2 year follow-up of neurodevelopment using a parental questionnaire
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Where

8 sites
CHU d'Angers
Angers, France
Hôpital Femme Mère Enfant
Bron, France
CHU de Montpellier
Montpellier, France
CHU de Nantes
Nantes, France
Cochin - APHP
Paris, France
Hopital Robert Debré
Paris, France
CHU de Strasbourg
Strasbourg, France
CHU de Tours
Tours, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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