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

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ClinicalTrials.gov Identifier: NCT01630278
Recruitment Status : Active, not recruiting
First Posted : June 28, 2012
Last Update Posted : October 13, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Patent Ductus Arteriosus Drug: Ibuprofen Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Early Targeted Ibuprofene Treatment of Patent Ductus Arteriosus (PDA) on Long Term Neurodevelopmental Outcome in Very Premature Infants (TRIOCAPI)
Study Start Date : March 2012
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019


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



Primary Outcome Measures :
  1. 2-year survival without cerebral palsy [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. ASQ (Ages and Stages Questionnaire) score at 2 years [ Time Frame: 2 years ]
  2. 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

  3. Comparison of outcome according to the McNamara stage at surgical ligation [ Time Frame: 2 years ]


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Ages Eligible for Study:   up to 28 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01630278


Locations
France
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
Sponsors and Collaborators
Nantes University Hospital
Investigators
Study Chair: Jean-Christophe ROZE, Professor Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01630278     History of Changes
Other Study ID Numbers: BRD/10/06-O
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Nantes University Hospital:
Prematurity
patent ductus arteriosus
ibuprofen

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action