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COMPLETED
NCT01630278
PHASE3

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

Sponsor: Nantes University Hospital

View on ClinicalTrials.gov

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

Interventions

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

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