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

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ClinicalTrials.gov Identifier: NCT01630278

Recruitment Status : Completed

First Posted : June 28, 2012

Last Update Posted : July 8, 2019

Sponsor:

Information provided by (Responsible Party):

Nantes University Hospital

Study Description

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 Design

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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)
Actual Study Start Date :	March 2012
Actual Primary Completion Date :	June 2019
Actual Study Completion Date :	June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ibuprofen Ibuprofen sodium Ibuprofen lysine Midol

Genetic and Rare Diseases Information Center resources: Patent Ductus Arteriosus

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

2-year survival without cerebral palsy [ Time Frame: 2 years ]

Secondary Outcome Measures :

ASQ (Ages and Stages Questionnaire) score at 2 years [ Time Frame: 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
Comparison of outcome according to the McNamara stage at surgical ligation [ Time Frame: 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Contacts and Locations

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

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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

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mitra S, Scrivens A, von Kursell AM, Disher T. Early treatment versus expectant management of hemodynamically significant patent ductus arteriosus for preterm infants. Cochrane Database Syst Rev. 2020 Dec 10;12:CD013278. doi: 10.1002/14651858.CD013278.pub2. Review.

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Responsible Party:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT01630278
Other Study ID Numbers:	BRD/10/06-O
First Posted:	June 28, 2012 Key Record Dates
Last Update Posted:	July 8, 2019
Last Verified:	July 2019

Keywords provided by Nantes University Hospital:


Prematurity patent ductus arteriosus ibuprofen

Additional relevant MeSH terms:

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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

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