EUCTR2016‐002974‐11‐ES

Trial name or title	Phase III, randomised, multi centre, double‐blind clinical trial to evaluate two echo‐guided administration regimens of ibuprofen in the treatment of patent ductus arteriosus: impact on intestinal prognosis
Methods	Randomised controlled trial
Participants	Preterm infants less than 33 weeks' PMA with a PDA ≥ 1.5 mm and medical decision to start drug treatment
Interventions	Two ECHO‐guided administration regimens of ibuprofen in the treatment of patent ductus arteriosus
Outcomes	Primary outcome: Incidence of NEC or API, defined as the presence of intestinal pneumatosis, pneumoperitoneum, or air in portal vein at time of discharge of Neonatology Department or at completed 40 weeks' PMA (whichever comes first). Secondary outcomes: numerous clinical and laboratory findings
Starting date	September 2016
Contact information	Mara Carmen Bravo Laguna, Hospital Universitario La Paz, Paseo de la Castellana 261, Madrid, 28046, Spain. Email: herranz.estelles@gmail.com
Notes	As of February 4, 2018, the trial was ongoing