Status:
COMPLETED
Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Collaborating Sponsors:
UPCET
PARTNERS for International clinical Research
Conditions:
Patency of the Ductus Arteriosus
Acetaminophen
Eligibility:
All Genders
23-28 years
Phase:
PHASE2
PHASE3
Brief Summary
TREOCAPA is a Phase II/III European Multicentre study concerning the prophylactic treatment by Acetaminophen of extremely preterm infant during the first five days after birth. The Phase II is a dose...
Detailed Description
The Phase II will be conducted in 11 NICUs, in 4 countries (France, UK, Finland and Denmark). The estimated recruitment period is 6 months to enroll 30 preterm infants of 23-26 weeks of gestation. Fou...
Eligibility Criteria
Inclusion
- Birth between 23-26 W for Phase II, between 23-28 W for Phase III
- Post natal age \< 12 hours
- Parental or Legal Authority Consent
- Parents with a social security or health insurance (if applicable according to the local regulation)
Exclusion
- Birth defect / Congenital anomaly
- Twin-to-twin transfusion syndrome not cured
- Suspicion of pulmonary hypoplasia
- Suspicion of hepatic impairment (hemorrhagic syndrome and/or severe hypoglycemia)
- Clinical instability that can lead to rapid death
- Impossibility to start treatment before 12 hours of life
- Parents placed under judicial protection
- Participation in other clinical trial using acetaminophen during the first 5 days of life, indomethacin or ibuprofen during the first 3 days of life or using rescue treatment of PDA not recommended in the TREOCAPA trial
Key Trial Info
Start Date :
October 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2024
Estimated Enrollment :
804 Patients enrolled
Trial Details
Trial ID
NCT04459117
Start Date
October 29 2020
End Date
June 20 2024
Last Update
April 2 2025
Active Locations (36)
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1
Centre Hospitalier Universitaire de Liège
Liège, Belgium
2
The Juliane Marie Centre, Rigshospitalet, Copenhagen University hospital
Copenhagen, Denmark, 2100
3
East Tallinn Central Hospital
Tallinn, Estonia
4
Tallinn Children's Hospital
Tallinn, Estonia