Brief Title
Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)
Official Title
Impact of Early Targeted Ibuprofene Treatment of Patent Ductus Arteriosus (PDA) on Long Term Neurodevelopmental Outcome in Very Premature Infants (TRIOCAPI)
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
2-year survival without cerebral palsy
Secondary Outcome
ASQ (Ages and Stages Questionnaire) score at 2 years
Condition
Patent Ductus Arteriosus
Intervention
Ibuprofen
Study Arms / Comparison Groups
Small ductus
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
363
Start Date
March 2012
Completion Date
June 2019
Primary Completion Date
June 2019
Eligibility Criteria
Inclusion Criteria: - Gestational less than 28 weeks - Postnatal age less than 12 hours
Gender
All
Ages
N/A - 28 Weeks
Accepts Healthy Volunteers
No
Contacts
Jean-Christophe ROZE, Professor, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01630278
Organization ID
BRD/10/06-O
Responsible Party
Sponsor
Study Sponsor
Nantes University Hospital
Study Sponsor
Jean-Christophe ROZE, Professor, Study Chair, Nantes University Hospital
Verification Date
July 2019