Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI) (TRIOCAPI)
Primary Purpose
Patent Ductus Arteriosus
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Ibuprofen
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Patent Ductus Arteriosus focused on measuring Prematurity, patent ductus arteriosus, ibuprofen
Eligibility Criteria
Inclusion Criteria:
- Gestational less than 28 weeks
- Postnatal age less than 12 hours
Sites / Locations
- University Hopsital
- University Hopsital
- University Hospital
- University Hospital
- University Hospital
- University Hospital
- Univesity Hospital
- University Hospital
- University Hospital (AP-HP Groupe hospitalier)
- University Hospital
- University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Placebo Comparator
Arm Label
Small ductus
Large ductus ibuprofen
Large ductus placebo
Arm Description
Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life
Outcomes
Primary Outcome Measures
2-year survival without cerebral palsy
Secondary Outcome Measures
ASQ (Ages and Stages Questionnaire) score at 2 years
Incidence of other prematurity-related morbidities (pulmonary, digestive, neurological, renal)
To compare the outcome between the large and the small ductus groups
Comparison of outcome according to the McNamara stage at surgical ligation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01630278
Brief Title
Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)
Acronym
TRIOCAPI
Official Title
Impact of Early Targeted Ibuprofene Treatment of Patent Ductus Arteriosus (PDA) on Long Term Neurodevelopmental Outcome in Very Premature Infants (TRIOCAPI)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patent Ductus Arteriosus
Keywords
Prematurity, patent ductus arteriosus, ibuprofen
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
363 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Small ductus
Arm Type
No Intervention
Arm Title
Large ductus ibuprofen
Arm Type
Experimental
Arm Description
Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
Arm Title
Large ductus placebo
Arm Type
Placebo Comparator
Arm Description
Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life
Primary Outcome Measure Information:
Title
2-year survival without cerebral palsy
Time Frame
2 years
Secondary Outcome Measure Information:
Title
ASQ (Ages and Stages Questionnaire) score at 2 years
Time Frame
2 years
Title
Incidence of other prematurity-related morbidities (pulmonary, digestive, neurological, renal)
Description
To compare the outcome between the large and the small ductus groups
Time Frame
2 years
Title
Comparison of outcome according to the McNamara stage at surgical ligation
Time Frame
2 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
28 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Gestational less than 28 weeks
Postnatal age less than 12 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Christophe ROZE, Professor
Organizational Affiliation
Nantes University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
University Hopsital
City
Angers
Country
France
Facility Name
University Hopsital
City
Bordeaux
Country
France
Facility Name
University Hospital
City
Créteil
Country
France
Facility Name
University Hospital
City
Grenoble
Country
France
Facility Name
University Hospital
City
Lille
Country
France
Facility Name
University Hospital
City
Marseille
Country
France
Facility Name
Univesity Hospital
City
Montpellier
Country
France
Facility Name
University Hospital
City
Nantes
Country
France
Facility Name
University Hospital (AP-HP Groupe hospitalier)
City
Paris
Country
France
Facility Name
University Hospital
City
Rennes
Country
France
Facility Name
University Hospital
City
Tours
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33307111
Citation
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.
Results Reference
derived
PubMed Identifier
33301630
Citation
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.
Results Reference
derived
Learn more about this trial
Early Ibuprofen Treatment of Patent Ductus Arteriosus (PDA) in Premature Infants (TRIOCAPI)
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