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Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)
Sponsor: Nantes University Hospital
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.
Official title: Impact of Early Targeted Ibuprofene Treatment of Patent Ductus Arteriosus (PDA) on Long Term Neurodevelopmental Outcome in Very Premature Infants (TRIOCAPI)
Key Details
Gender
All
Age Range
Any - 28 Weeks
Study Type
INTERVENTIONAL
Enrollment
363
Start Date
2012-03
Completion Date
2019-06
Last Updated
2026-09-14
Healthy Volunteers
No
Conditions
Interventions
Ibuprofen
Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
Placebo
Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life
Locations (11)
University Hopsital
Angers, France
University Hopsital
Bordeaux, France
University Hospital
Créteil, France
University Hospital
Grenoble, France
University Hospital
Lille, France
University Hospital
Marseille, France
Univesity Hospital
Montpellier, France
University Hospital
Nantes, France
University Hospital (AP-HP Groupe hospitalier)
Paris, France
University Hospital
Rennes, France
University Hospital
Tours, France