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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Nantes University Hospital

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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 ]

Original Secondary Outcome:

• ASQ 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 ]

Information By: Nantes University Hospital

Dates:
Date Received: June 11, 2012
Date Started: March 2012
Date Completion: March 2019
Last Updated: March 7, 2016
Last Verified: March 2016