Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)
NCT ID: NCT01630278
Last Updated: 2019-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
363 participants
INTERVENTIONAL
2012-03-31
2019-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Small ductus
No interventions assigned to this group
Large ductus ibuprofen
Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
Ibuprofen
Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
Large ductus placebo
Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life
Placebo
Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life
Interventions
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Ibuprofen
Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
Placebo
Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life
Eligibility Criteria
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Inclusion Criteria
* Postnatal age less than 12 hours
28 Weeks
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Jean-Christophe ROZE, Professor
Role: STUDY_CHAIR
Nantes University Hospital
Locations
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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
Countries
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References
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Roze JC, Cambonie G, Le Thuaut A, Debillon T, Ligi I, Gascoin G, Patkai J, Beuchee A, Favrais G, Flamant C, Durrmeyer X, Clyman R. Effect of Early Targeted Treatment of Ductus Arteriosus with Ibuprofen on Survival Without Cerebral Palsy at 2 Years in Infants with Extreme Prematurity: A Randomized Clinical Trial. J Pediatr. 2021 Jun;233:33-42.e2. doi: 10.1016/j.jpeds.2020.12.008. Epub 2020 Dec 9.
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(12):CD013278. doi: 10.1002/14651858.CD013278.pub2.
Other Identifiers
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BRD/10/06-O
Identifier Type: -
Identifier Source: org_study_id
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