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

July 5, 2019 updated by: Nantes University Hospital

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

363

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • University Hopsital
      • Bordeaux, France
        • University Hopsital
      • Créteil, France
        • University Hospital
      • Grenoble, France
        • University Hospital
      • Lille, France
        • University Hospital
      • Marseille, France
        • University Hospital
      • Montpellier, France
        • Univesity Hospital
      • Nantes, France
        • University Hospital
      • Paris, France
        • University Hospital (AP-HP Groupe hospitalier)
      • Rennes, France
        • University Hospital
      • Tours, France
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Gestational less than 28 weeks
  • Postnatal age less than 12 hours

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Small ductus
EXPERIMENTAL: Large ductus ibuprofen
Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
Drug: Ibuprofen
Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
PLACEBO_COMPARATOR: Large ductus placebo
Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
2-year survival without cerebral palsy
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ASQ (Ages and Stages Questionnaire) score at 2 years
Time Frame: 2 years
2 years
Incidence of other prematurity-related morbidities (pulmonary, digestive, neurological, renal)
Time Frame: 2 years
To compare the outcome between the large and the small ductus groups
2 years
Comparison of outcome according to the McNamara stage at surgical ligation
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Study Chair: Jean-Christophe ROZE, Professor, Nantes University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2012

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

June 11, 2012

First Submitted That Met QC Criteria

June 26, 2012

First Posted (ESTIMATE)

June 28, 2012

Study Record Updates

Last Update Posted (ACTUAL)

July 8, 2019

Last Update Submitted That Met QC Criteria

July 5, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD/10/06-O

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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