Long-term follow-up of premature infants treated for patent ductus arteriosus
Official title: Long Term Follow-up of the TREOCAPA (Prophylactic TREatment Of the duCtus Arteriosus in Preterm Infants by Acetaminophen) Study (TREOCAPA-LT)
Run by Institut National de la Santé Et de la Recherche Médicale, France · NCT06064825 · Data updated 2026-11-12
This study looks at how well paracetamol worked to treat a heart condition in premature babies and how it affects their development as they grow older.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 23 Months to 27 Months |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 8 sites (Angers and 7 other locations) |
| Status | Recruiting |
| Started | December 12, 2023 |
| Main results expected | December 2026 |
| Study ends | June 2027 |
| Registry record updated | April 16, 2026 |
| Trial ID | NCT06064825 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are infants who were part of the TREOCAPA phase III trial and are currently between 23.5 and 27.5 months corrected age.
✕Probably not a fit
Patients who are nearing the end of life or experiencing severe medical events, as well as those whose parents opt out of participation, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to follow up on infants who participated in the TREOCAPA phase III trial, focusing on the long-term outcomes of those treated for patent ductus arteriosus (PDA) using paracetamol. The study will assess neurodevelopmental outcomes at 23.5 to 27.5 months corrected age through parental questionnaires. By evaluating the effectiveness of paracetamol as a treatment for PDA, the study seeks to provide insights into its impact on survival and cognitive functioning in extremely preterm infants.
Why it matters
Potential benefit: If successful, this study could provide valuable information on the long-term neurodevelopmental outcomes of premature infants treated with paracetamol for PDA.
How similar studies have gone: While the TREOCAPA phase III trial is ongoing, previous studies have shown that traditional treatments for PDA have significant limitations, making this approach with paracetamol a novel consideration.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
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
Show 2 more locations
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CHU de Strasbourg
Strasbourg, France Recruiting -
CHU de Tours
Tours, France Recruiting
Study contacts
- Study coordinator: Gilles Cambonie, MD/PHD
- Email: g-cambonie@chu-montpellier.fr
- Phone: +33467336609
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.