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Abstract
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.
- cardiology
- circulatory
- imaging
- intensive care
- neonatology
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Footnotes
Contributors AsK assisted in designing and planning the study and wrote the first draft of the protocol. VS conceived the idea, designed the trial and critically edited and approved the manuscript. TPO assisted in planning the study and critically edited and approved the manuscript. SM assisted in designing and planning the study and critically edited and approved the manuscript. ArK assisted in planning the study and wrote the first draft of the protocol. MS assisted in designing and planning the study and critically edited and approved the manuscript. SSS assisted in planning the study and critically edited and approved the manuscript. SD assisted in designing and planning the study and critically edited and approved the manuscript.
Funding This study and the manuscript did not attract funding from any source.
Competing interests None declared.
Patient consent This is a study protocol and hence consent form is not applicable at this stage.
Ethics approval Institute Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement No additional unpublished data are available in this case as this is a protocol. Data that are being collected can be accessed by one of the site investigators (VS, SM and MS), and they should be preferably contacted through the corresponding author to obtain the data.