NCT02819414

Trial name or title	Time to re‐evaluate the kinder gentler approach to patent ductus arteriosus (PDA) in the preterm neonate
Methods	Randomised quadruple‐masked trial (participant, care provider, investigator, outcomes assessor)
Participants	Preterm neonates < 30 weeks' PMA with a PDA of borderline significance
Interventions	Paracetamol drops 15 mg/kg/dose × 4/day diluted 1:15 yielding dose of 2.25 mL/kg/dose to be given for 3 days
Outcomes	Primary outcomes: to demonstrate a decrease in the composite outcome of death or severe morbidity chronic lung disease (CLD), as shown by decreased time on supplemental oxygen and assisted ventilation. Secondary outcomes: to demonstrate a decrease in subsequently diagnosed haemodynamically significant PDA, including decrease in the need for subsequent therapy for PDA closure, decrease in surgical PDA ligations; to demonstrate a decrease in necrotizing enterocolitis (NEC) and/or ROP with treatment and to demonstrate no adverse effect on blood flow in anterior cerebral, superior mesenteric and renal arteries.
Starting date	June 2016
Contact information	Cathy Hammerman, Shaare Zedek Medical Center, Jerusalem, Israel
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