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

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Patent ductus arteriosus
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Safety and Effectiveness Study With a New PDA Occluder for Closure of Patent Ductus Arteriosus

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