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

Recruiting now · Has a placebo group

Conditions studied: Patency of the Ductus Arteriosus Acetaminophen Extreme Prematurity

In brief

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 corrected age in children born at less than 29 weeks of gestational age who were treated with paracetamol during the first 5 days of life in the TREOCAPA phase III trial.

Key facts

Study ID

NCT06064825

Run by

Institut National de la Santé Et de la Recherche Médicale, France

People needed

500

Starts

2023-12-12

Expected to finish

2027-06-01

Last updated by the study team

2026-04-16

Who can join

Age: 2 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CHU d'Angers — Angers, France (enrolling)
• Hôpital Femme Mère Enfant — Bron, France (enrolling)
• CHU de Montpellier — Montpellier, France (enrolling)
• CHU de Nantes — Nantes, France (enrolling)
• Cochin - APHP — Paris, France (enrolling)
• Hopital Robert Debré — Paris, France (enrolling)
• CHU de Strasbourg — Strasbourg, France (enrolling)
• CHU de Tours — Tours, France (enrolling)

Full record on ClinicalTrials.gov

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