Kumar Ashutosh, Sundaram Venkataseshan, Yadav Rahul, Oleti Tejo Pratap, Murki Srinivas, Krishna Arun, Sundaram Mangalabharathi, Saini Shiv Sajan, Dutta Sourabh
Division of Neonatology, Department of Pediatrics, Advanced Pediatrics Centre, Postgraduate Institute of Medical Education and Research, Chandigarh, India.
Department of Neonatology, Fernandez Hospital, Bogulkunta, Hyderabad, Telangana, India.
BMJ Paediatr Open. 2017 Aug 11;1(1):e000143. doi: 10.1136/bmjpo-2017-000143. eCollection 2017.
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.
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.
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.
CTRI/2014/08/004805.
血流动力学显著的动脉导管未闭（hsPDA）是早产儿死亡和发病的常见原因。现有的布洛芬或吲哚美辛药物治疗有多种不良反应。因此，需要通过适当的研究设计来测试像对乙酰氨基酚这种口服途径且副作用较小的替代药物，同时将偏倚风险降至最低，以便得出结论。
多中心、随机、活性对照、非劣效性设计。主要目的是研究与口服布洛芬相比，口服对乙酰氨基酚对孕周小于32周的早产儿hsPDA闭合的疗效。将通过基于网络的随机化和分配隐藏进行操作；治疗团队、研究人员、结果评估者和实验室人员将对干预措施不知情。超声心动图图像将进行编码以便独立审查。在研究药物最后一剂结束时或更早实现动脉导管未闭闭合将作为研究终点。将纳入196例新生儿，非劣效界值为15%。将进行意向性分析和符合方案分析，以评估主要结局中沾染和违反方案情况的影响。
该试验将遵循国际临床试验伦理准则。试验方案已获得所有三个中心的机构伦理委员会批准。所有严重不良事件将详细报告给机构伦理委员会。将从父母一方获得书面知情同意书。目前尚未制定传播计划。
CTRI/2014/08/004805。
