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NCT01630278 Clinical Trial

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

Patent Ductus Arteriosus Clinical Trial

— TRIOCAPI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01630278
Other study ID # BRD/10/06-O
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date March 2012
Est. completion date June 2019

Study information
Verified date July 2019
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 363
Est. completion date June 2019
Est. primary completion date June 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Weeks
Eligibility Inclusion Criteria:

- Gestational less than 28 weeks

- Postnatal age less than 12 hours

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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

Locations
Country Name City State
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

Sponsors (1)
Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 2-year survival without cerebral palsy 2 years
Secondary ASQ (Ages and Stages Questionnaire) score at 2 years 2 years
Secondary Incidence of other prematurity-related morbidities (pulmonary, digestive, neurological, renal) To compare the outcome between the large and the small ductus groups 2 years
Secondary Comparison of outcome according to the McNamara stage at surgical ligation 2 years
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