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A comparison of different dosing regimen of intravenous paracetamol for hemodynamically significant patent ductus arteriosus closure in premature neonates <32 weeks: a prospective observational study

Journal of Perinatology (2024)Cite this article

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Abstract

Objective

To compare the efficacy of low vs conventional dose intravenous paracetamol in early closure of haemodynamically significant patent ductus arteriosus within 7 days of life.

Methods

Preterm infants (<32 weeks of gestation) having echocardiographic evidence of hsPDA were given low dose (15 mg/kg initially followed by 7.5 mg/kg every 6 hourly) vs conventional dose (15 mg/kg every 6 hourly) for 5–7 days.

Results

In total, 56 infants (28 in each group) were enrolled. Ductal closure was achieved in 96% infants in the low-dose group and 100% infants in the conventional group (P = 1.00). Secondary outcomes, including ductal reopening and need for the second course of medical treatment (21% vs 3.5%, P = 0.1), median duration of hospital stay [30 (15, 43.5) vs 27 (18.5,45), P = 0.64], cumulative oxygen requirement [17.5 (7, 25) vs 14 (8.5, 25), P = 0.89], mortality (10.7% vs 25%, P = 0.29) and other morbidities, were comparable in both the groups. Median paracetamol levels were comparable in both the groups [53.4 μg/L (47, 2,70) vs 62.5 (55.6, 81.2), P = 0.67].

Conclusion

Low-dose paracetamol was non-inferior to conventional dose paracetamol for early ductal closure in preterm infants.

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Data availability

Data are presented in this paper and in the online supplementary material. Correspondence and requests for data should be addressed to Anitha Haribalakrishna.

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Acknowledgements

The authors thank the Dean, Dr Sangeeta Ravat for permitting to publish the manuscript.

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Authors and Affiliations

  1. Department of Neonatology, Seth GS Medical College and King Edward Memorial Hospital, Mumbai, India

    Nikita Goyal & Anitha Haribalakrishna

  2. Department of Clinical Pharmacology, Seth GS Medical College and King Edward Memorial Hospital, Mumbai, India

    Bhaskar Krishnamurthy

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  1. Nikita Goyal
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  2. Anitha Haribalakrishna
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  3. Bhaskar Krishnamurthy
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Contributions

AH conceptualized and designed the work, did the statistical analysis, edited the manuscript, and gave final approval. NG drafted the initial manuscript, did statistical analysis and edited the final version. BK edited the manuscript, gave inputs, and approved the final version.

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Correspondence to Anitha Haribalakrishna.

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The authors declare no competing interests.

Ethics approval and consent to participate

The study was approved by the Institutional Ethics Committee and participants were enrolled after obtaining written informed consent. The study was conducted as per the Declaration of Helsinki.

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Goyal, N., Haribalakrishna, A. & Krishnamurthy, B. A comparison of different dosing regimen of intravenous paracetamol for hemodynamically significant patent ductus arteriosus closure in premature neonates <32 weeks: a prospective observational study. J Perinatol (2024). https://doi.org/10.1038/s41372-024-01966-8

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