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A pilot randomised blinded placebo-controlled trial of paracetamol for later treatment of a patent ductus arteriosus

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A Correction to this article was published on 14 November 2018

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Abstract

Objective

To explore the efficacy and risks of oral paracetamol in later (>2 weeks old) treatment of patent ductus arteriosus (PDA).

Study design

A multicentre double-blind placebo-controlled randomised pilot trial in three neonatal intensive care units in Australia. Infants born <33 weeks with haemodynamically significant PDA were treated with a 5-day course of oral paracetamol or placebo. Cardiac ultrasounds were used to document haemodynamic parameters. The primary outcome analysed was ductal closure by 48 h after treatment completion. Secondary outcomes included reduction in ductal diameter >25% and safety.

Results

Fifty-five infants were enrolled, of whom 27 received paracetamol and 28 placebo. Eighty percent had received previous non-steroidal anti-inflammatory drug. Mean postnatal age was 25 days. Four of the 27 ducts treated with paracetamol closed vs. 0/28 treated with placebo (p = 0.05). An additional 13/27 given  paracetamol vs. 7/28 given placebo showed significant constriction (p = 0.008). No adverse effects were observed .

Conclusions

There was some evidence of increased closure with oral paracetamol at postnatal age >2 weeks; however, the overall efficacy was not high.

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Change history

  • 14 November 2018

    In the published version of this paper the author Yan Chen was missed out of the author list. This has now been corrected in the HTML and PDF versions of the paper.

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Acknowledgements

This work was supported in part by the Mill House Foundation and Heart Research Australia.

Author information

Author notes

  1. Australian New Zealand Clinical Trials Registry (ACTRN12611000741987).

Authors and Affiliations

  1. Department of Neonatology, Royal North Shore Hospital and University of Sydney, Sydney, NSW, Australia

    Martin Kluckow, Michele Jeffery, Deepa Desai & Yan Chen

  2. The Canberra Hospital, Canberra, ACT, Australia

    Hazel Carlisle & Margaret Broom

  3. Royal Prince Alfred Women and Babies Hospital and University of Sydney, Sydney, NSW, Australia

    Patricia Woods & Nick Evans

Authors
  1. Martin Kluckow
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  2. Hazel Carlisle
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  3. Margaret Broom
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  4. Patricia Woods
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  5. Michele Jeffery
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  6. Deepa Desai
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  7. Yan Chen
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  8. Nick Evans
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Corresponding author

Correspondence to Martin Kluckow.

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The authors declare that they have no conflict of interest.

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Kluckow, M., Carlisle, H., Broom, M. et al. A pilot randomised blinded placebo-controlled trial of paracetamol for later treatment of a patent ductus arteriosus. J Perinatol 39, 102–107 (2019). https://doi.org/10.1038/s41372-018-0247-z

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  • DOI: https://doi.org/10.1038/s41372-018-0247-z

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