RT Journal Article SR Electronic T1 Oral paracetamol versus oral ibuprofen for closure of haemodynamically significant patent ductus arteriosus in preterm neonates (<32 weeks): a blinded, randomised, active-controlled, non-inferiority trial JF BMJ Paediatrics Open FD BMJ Publishing Group Ltd SP e000143 DO 10.1136/bmjpo-2017-000143 VO 1 IS 1 A1 Ashutosh Kumar A1 Venkataseshan Sundaram A1 Rahul Yadav A1 Tejo Pratap Oleti A1 Srinivas Murki A1 Arun Krishna A1 Mangalabharathi Sundaram A1 Shiv Sajan Saini A1 Sourabh Dutta YR 2017 UL http://bmjpaedsopen.bmj.com/content/1/1/e000143.abstract AB Introduction Haemodynamically significant patent ductus arteriosus (hsPDA) is a common cause of mortality and morbidity in preterm infants. Existing medical therapies with ibuprofen or indomethacin have multiple adverse effects. Hence, an alternative drug like paracetamol given through oral route with less side effects need to be tested in an appropriate study design with least risk of bias to arrive at a conclusion.Methods and analysis Multisite, randomised, active-controlled, non-inferiority design. The primary objective is to study the efficacy of oral paracetamol for closure of hsPDA in comparison to oral ibuprofen in preterm neonates of <32 weeks’ gestation. Randomisation web-based and allocation concealment would be done; the treating team, investigators, outcome assessors and laboratory personnel would be blinded from the intervention. Echocardiography images would be coded for independent review. Closure of PDA by the end of last dose of study drug or earlier would be the study endpoint. A sample size of 196 neonates would be enrolled with a non-inferiority margin of 15%. Both intention-to-treat and per-protocol analysis will be done to assess the effect of contamination and protocol violations in the primary outcome.Ethics and dissemination The trial would follow international code of ethics for clinical trial. The trial protocol was approved by the Institute Ethics Committee of all three centres. All serious adverse events would be reported in detail to the Institute Ethics Committee. A written informed consent would be obtained from one of the parents. No plan has been made for dissemination.Trial registration number CTRI/2014/08/004805.