Long-term follow-up of premature infants treated for patent ductus arteriosus
Long Term Follow-up of the TREOCAPA (Prophylactic TREatment Of the duCtus Arteriosus in Preterm Infants by Acetaminophen) Study (TREOCAPA-LT)
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 23 Months to 27 Months |
| Sex | All |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France Government |
| Locations | 8 sites (Angers and 7 other locations) |
| Trial ID | NCT06064825 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Angers and 7 other locations
- 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)
Study contacts
- Study coordinator: Gilles Cambonie, MD/PHD
- Email: g-cambonie@chu-montpellier.fr
- Phone: +33467336609
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.