Status:
RECRUITING
Long Term Follow-up of the TREOCAPA Study (TREOCAPA-LT)
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Patency of the Ductus Arteriosus Acetaminophen Extreme Prematurity
Eligibility:
All Genders
23-27 years
Brief Summary
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 condit...
Detailed Description
The ductus arteriosus (DA) is a large channel found normally in all mammalian foetuses, connecting the main pulmonary trunk with the left-sided descending aorta. During fetal life, it diverts most of ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 12 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06064825
Start Date
December 12 2023
End Date
June 1 2027
Last Update
April 4 2025
Active Locations (8)
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1
CHU d'Angers
Angers, France
2
Hôpital Femme Mère Enfant
Bron, France
3
CHU de Montpellier
Montpellier, France
4
CHU de Nantes
Nantes, France