Prophylactic treatment of the ductus arteriosus in preterm infants by paracetamol
- Conditions
- Patent ductus arteriosusTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2019-004297-26-FI
- Lead Sponsor
- Institut National de la Santé et de la Recherche Médicale (INSERM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 824
? 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
? 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method