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. 2017 Aug 11;1(1):e000143.
doi: 10.1136/bmjpo-2017-000143. eCollection 2017.

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

Ashutosh Kumar  1 , Venkataseshan Sundaram  1 , Rahul Yadav  2 , Tejo Pratap Oleti  2 , Srinivas Murki  2 , Arun Krishna  3 , Mangalabharathi Sundaram  3 , Shiv Sajan Saini  1 , Sourabh Dutta  1
Affiliations

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

Ashutosh Kumar et al. BMJ Paediatr Open. .

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.

Keywords: cardiology; circulatory; imaging; intensive care; neonatology.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Study flow as per the Consolidated Standards of Reporting Trials (CONSORT) recommendations.
Figure 2
Figure 2
Operational flow and timeline of the study. hsPDA, haemodynamically significant patent ductus arteriosus.
Figure 3
Figure 3
Timeline of assessments by bedside echocardiography. hsPDA, haemodynamically significant patent ductus arteriosus.
See this image and copyright information in PMC

References

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