NCT01630278

Trial name or title	Early ibuprofen treatment of patent ductus arteriosus (PDA) in premature infants (TRIOCAPI)
Methods	Randomised controlled trial
Participants	385 very premature (PMA ≤ 28 weeks) infants with a large ductus, selected by an early ECHO
Interventions	Ibuprofen or placebo before 12 hours of life. Follow‐up will include repeated ECHO and cranial ultrasound at 36 hours, 14 days and 36 weeks of postconceptional age
Outcomes	Primary outcome: 2‐year survival without cerebral palsy Secondary outcomes: 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 and outcomes according to the McNamara stage at surgical ligation
Starting date	March 2012
Contact information	Prof. Véronique Gournay, Nantes University Hospital Phone +33 2 40 08 77 84; veronique.gournay@chu‐nantes.fr
Notes	ClinicalTrials.gov identifier: NCT01630278 As of October 13, 2017, the study was active but not recruiting