Condition: Patency of the Ductus Arteriosus Acetaminophen Extreme Prematurity · Sponsor: Institut National de la Santé Et de la Recherche Médicale, France
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 trial that assesses prophylactic use of paracetamol to improve survival without severe neonatal morbidity until discharge from hospital in infants of 23-28 weeks of gestational age. As long-term follow-up was not planned by the TREOCAPA protocol, TREOCAPA-LT study will use an existing European research infrastructure, the RECAP Preterm platform (https://recap-preterm.eu/), to follow-up the patients enrolled in the TREOCAPA trial using a parent-report questionnaire at 2 years of corrected age. The TREOCAPA-LT primary hypothesis is that there will be improved cognitive outcome at 2 years of correct…
This description comes directly from the study's public registry record.
Gilles Cambonie, MD/PHD · +33467336609 · g-cambonie@chu-montpellier.fr
Andrei Morgan, FRCPCH, MSc, PhD · +33171722987 · andrei.morgan@inserm.fr
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| CHU d'Angers | Angers, France | Recruiting |
| Hôpital Femme Mère Enfant | Bron, France | Recruiting |
| CHU de Montpellier | Montpellier, France | Recruiting |
| CHU de Nantes | Nantes, France | Recruiting |
| Cochin - APHP | Paris, France | Recruiting |
| Hopital Robert Debré | Paris, France | Recruiting |
| CHU de Strasbourg | Strasbourg, France | Recruiting |
| CHU de Tours | Tours, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06064825