NCT02884219

Trial name or title	Multicenter, randomised non‐inferiority trial of early treatment versus expectative management of patent ductus arteriosus in preterm infants (BeNeDuctus Trial ‐ Belgium Netherlands Ductus Trial)
Methods	Randomised controlled trial
Participants	Preterm infants < 28 weeks' PMA with a PDA (PDA diameter > 1.5 mm) and ductal (predominantly) left‐to‐right shunt
Interventions	Active comparator: early treatment with cyclooxygenase inhibitors: treatment of PDA that starts within the first 3 days of life using cyclooxygenase‐inhibitors (Ibuprofen or Indomethacin) Sham comparator: expectative treatment: expectative PDA management is characterised as 'watchful waiting'. No intervention is initiated with the intention to close a PDA
Outcomes	Primary outcome: composite of mortality, and/or NEC, and/or BPD Secondary outcomes: short‐term sequelae of cardiovascular failure (time frame: day 1 up to 3 months); at the time of discharge, the incidence of cardiovascular failure is calculated short‐term sequelae of adverse events (time frame: day 1 up to 3 months); at the time of discharge, the number of all adverse events are calculated long‐term neurodevelopmental consequences assessed with BSID‐III‐NL (time frame: assessed at a corrected age of 2 years). All patients in this study will be included in the National Neonatal Follow Up Program and are therefore seen at a corrected age of 24 months. Their neurodevelopment is assessed with the Bayley Scales of Infant and Toddler Development, Third Dutch Edition (BSID‐III‐NL).
Starting date	December 2016
Contact information	Contact: Willem P de Boode, MD PhD; +31 24 361 44 30; email: willem.deboode@radboudumc.nl
Notes	Expected end date: July 2019

API: Defined as the presence of intestinal pneumatosis, pneumoperitoneum, or air in the portal vein ASQ: Acoustic structure quantification BSID‐III‐NL: Bayley Scales of Infant Development III (Nl ‐ Netherlands) ECHO: echocardiographically/echocardiography IV: intravenous mm: millimetre NEC: Necrotizing enterocolitis NSAID: non‐steroidal anti‐inflammatory drug PDA: patent ductus arteriosus PMA: postmenstrual age.