NCT01630278

Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)

Impact of Early Targeted Ibuprofene Treatment of Patent Ductus Arteriosus (PDA) on Long Term Neurodevelopmental Outcome in Very Premature Infants (TRIOCAPI)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 28 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Patent Ductus Arteriosus

Interventions

Type	Name	Description
DRUG	Ibuprofen	Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
DRUG	Placebo	Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life

Timeline

• Start date: 2012-03-01
• Primary completion: 2019-06-01
• Completion: 2019-06-01
• First posted: 2012-06-28
• Last updated: 2019-07-08

Locations

11 sites across 1 country: France