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Original research
Low dose paracetamol for management of patent ductus arteriosus in very preterm infants: a randomised non-inferiority trial
  1. Haribalakrishna Balasubramanian1,
  2. Vaibhav Jain1,
  3. Parag Bhalgat1,
  4. Shalin Parikh1,
  5. Nandkishore Kabra1,
  6. Diwakar Mohan2,
  7. Kshitij Sheth1
  1. 1 Department of Neonatology, Surya Hospitals, Mumbai, Maharashtra, India
  2. 2 Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
  1. Correspondence to Dr Haribalakrishna Balasubramanian, Neonatology, Surya Hospitals, Mumbai, Maharashtra, India; drhari{at}suryahospitals.com

Abstract

Objective To compare the efficacy of low dose-short course intravenous paracetamol with a conventional dose regimen for early targeted closure of patent ductus arteriosus (PDA).

Design Single-centre, double-blinded, active controlled, randomised non-inferiority trial.

Setting Level III neonatal intensive care unit in Western India.

Patients Preterm infants <30 weeks of gestation requiring mechanical ventilation, or continuous positive airway pressure with FiO2 ≥0.35 and diagnosed with a haemodynamically significant PDA (hsPDA) at 18–24 hours of postnatal age.

Interventions Low dose (10 mg/kg/dose 6 hourly for 72 hours) versus conventional dose (15 mg/kg/dose 6 hourly for 120 hours) intravenous paracetamol treatment.

Main outcome measures Comparison of the rates of ductal closure at completion of sixth postnatal day, using a prespecified non-inferiority margin of 20%.

Results A total of 102 infants were enrolled. The median gestational age and birth weight of the included infants were 26.4 weeks and 830 g. At completion of the sixth postnatal day, closure of PDA was achieved in 92% of infants in the low dose group as compared with 94% of those in the standard dose group (risk difference: −1.6%, 95% CI: −11.6% to 8.5%, p=0.38). The rates of rescue therapies, adverse effects and other neonatal morbidities were comparable in both groups.

Conclusion In very preterm infants on significant respiratory support, low dose-short course intravenous paracetamol treatment was non-inferior to a conventional dosing regime of paracetamol for closure of hsPDA in the first week of postnatal age. Larger studies with narrow margins of non-inferiority are required to confirm our findings.

Trial registration number CTRI/2017/10/010012.

  • cardiology
  • neonatology

Data availability statement

Data are available on reasonable request.

https://doi.org/10.1136/archdischild-2022-323781

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    Data availability statement

    Data are available on reasonable request.

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    Footnotes

    • Twitter @drparagbhalgat, @Shalin Parikh

    • Contributors HB accepts full responsibility for the conduct of the study, had access to the data, and controlled the decision to publish.HB conceptualised the study and drafted the initial manuscript. VJ SP and HB collected the data and carried out the initial analysis. PB performed echocardiography of the study infants. NK conducted literature search, supervised the study conduct and critically reviewed the manuscript. DM provided statistical expertise, assisted in data analysis and critically reviewed the manuscript. VJ and KS were involved in patient screening and enrolment and contributed to data analysis.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.