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Objective <p>To evaluate whether paracetamol serum concentration monitoring is associated with ductal closure, hepatic or renal toxicity, and to assess the cost-effectiveness of routine serum monitoring in preterm infants treated for haemodynamically significant patent ductus arteriosus (hsPDA).</p> Study design <p>A multi-centre retrospective cohort study of 172 preterm infants treated with paracetamol for hsPDA (2018–2024). Associations between paracetamol&#xa0;serum concentrations, clinical outcomes, and monitoring costs were examined using multivariable mixed-effects modelling and micro-costing analysis.</p> Results <p>PDA closure after the first course occurred in 40.7%. On multivariate analysis, paracetamol concentration monitoring was not associated with PDA closure (OR 0.98, 95% CI:0.92–1.03, <i>p</i> = 0.68), ALT elevation (<i>p</i> = 0.443) or creatinine rise (<i>p</i> = 0.88). Across 222 assays, routine monitoring cost £6036 (£120.72 per actionable result) and remained non-cost effective across all sensitivity analyses.</p> Conclusion <p>Routine monitoring of paracetamol serum concentrations offers minimal clinical value and is not cost-effective. Selective, indication-based monitoring should replace universal testing.</p>

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The clinical utility of paracetamol serum concentration monitoring for patent ductus arteriosus treatment in preterm infants

  • 期刊论文

  • 发表日期：

    2026年6月22日

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  • Amira Ali,
  • Mahmoud Koritena,
  • Javeria Ahmed,
  • Mudasir Nazir,
  • David Mcnulty,
  • Sherif Dabbour,
  • Mona Noureldein

摘要

Objective

To evaluate whether paracetamol serum concentration monitoring is associated with ductal closure, hepatic or renal toxicity, and to assess the cost-effectiveness of routine serum monitoring in preterm infants treated for haemodynamically significant patent ductus arteriosus (hsPDA).

Study design

A multi-centre retrospective cohort study of 172 preterm infants treated with paracetamol for hsPDA (2018–2024). Associations between paracetamol serum concentrations, clinical outcomes, and monitoring costs were examined using multivariable mixed-effects modelling and micro-costing analysis.

Results

PDA closure after the first course occurred in 40.7%. On multivariate analysis, paracetamol concentration monitoring was not associated with PDA closure (OR 0.98, 95% CI:0.92–1.03, p = 0.68), ALT elevation (p = 0.443) or creatinine rise (p = 0.88). Across 222 assays, routine monitoring cost £6036 (£120.72 per actionable result) and remained non-cost effective across all sensitivity analyses.

Conclusion

Routine monitoring of paracetamol serum concentrations offers minimal clinical value and is not cost-effective. Selective, indication-based monitoring should replace universal testing.