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

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.