Trial name or title | Paracetamol and patent ductus arteriosus (PDA) |
Methods | Randomised controlled trial |
Participants | Preterm infants with a haemodynamically significant PDA |
Interventions | Group 1: paracetamol orally at a dose of 15 mg/kg every 6 h × 3 days. Group 2: indomethacin intravenously 0.2 mg/kg/dose for 3 doses |
Outcomes | Primary outcome: closure of the ductus within 3 days. Secondary outcomes: absence of peripheral vasoconstriction, Doppler flow velocity in the anterior cerebral artery, superior mesenteric artery and renal artery before and after pharmacological treatment, absence of hepatotoxicity |
Starting date | 6 February 2011 |
Contact information | Cathy Hammerman, Shaare Zedek Medical centre, Israel. cathy@cc.huji.ac.il |
Notes | ClinicalTrials.gov identifier: NCT01291654 |