EUCTR2019-004297-26-PTActive, not recruitingPhase 1
Prophylactic treatment of the ductus arteriosus in preterm infants by acetaminophen - TREOCAPA
Institut National de la Santé et de la Recherche Médicale (INSERM)0 sites824 target enrollmentStarted: June 4, 2020Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 824
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •? 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)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 824
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •? Birth defect / Congenital anomaly
- •? Twin-to-twin transfusion syndrome
- •? 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
Investigators
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