Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)
- Registration Number
- NCT01630278
- Lead Sponsor
- Nantes University Hospital
- Brief Summary
Very premature infants with a large ductus, selected by an early echocardiogram, will receive either ibuprofen or placebo before 12 hours of life. Follow-up will include repeated echocardiograms and cranial ultrasound at 36 hours, 14 days and 36 weeks of postconceptional age. The primary outcome will be survival without cerebral palsy at years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 363
Inclusion Criteria
- Gestational less than 28 weeks
- Postnatal age less than 12 hours
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Large ductus placebo Placebo Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life Large ductus ibuprofen Ibuprofen Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
- Primary Outcome Measures
Name Time Method 2-year survival without cerebral palsy 2 years
- Secondary Outcome Measures
Name Time Method ASQ (Ages and Stages Questionnaire) score at 2 years 2 years Incidence of other prematurity-related morbidities (pulmonary, digestive, neurological, renal) 2 years To compare the outcome between the large and the small ductus groups
Comparison of outcome according to the McNamara stage at surgical ligation 2 years
Trial Locations
- Locations (4)
University Hopsital
🇫🇷Bordeaux, France
Univesity Hospital
🇫🇷Montpellier, France
University Hospital
🇫🇷Tours, France
University Hospital (AP-HP Groupe hospitalier)
🇫🇷Paris, France