Subgroup analysis of the early paracetamol trial to preterm infants found haemodynamic changes and improved

Antti Härmä1, Outi Aikio1, Pia Härkin1

  • 1PEDEGO Research Unit and Medical Research Center Oulu, University of Oulu, Oulu, Finland; Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland.

Insights

Early intravenous paracetamol in preterm infants improved oxygenation and closed the ductus arteriosus. This treatment had minor effects on blood pressure but enhanced brain tissue oxygenation.

Area of Science:

  • Neonatalogy
  • Pharmacology
  • Pediatric Critical Care

Background:

  • Previous randomized trials indicated early intravenous paracetamol accelerates ductus arteriosus contraction in very preterm infants (<32 weeks gestation).

Purpose of the Study:

  • To sequentially monitor the effects of paracetamol on blood pressure and brain tissue oxygenation in very preterm infants participating in a randomized trial.

Main Methods:

  • A double-blind trial involving 48 very premature infants receiving intravenous paracetamol or placebo within 24 hours of birth for four days.
  • Systematic measurements included blood pressure, peripheral oxygen saturation (SpO2), regional cerebral oxygen saturation (rcSO2), and cerebral fractional tissue oxygen extraction (cFTOE).

Main Results:

  • Paracetamol loading dose transiently decreased arterial blood pressure.
  • Paracetamol-treated infants showed higher SpO2 and rcSO2 compared to placebo.
  • Lower cFTOE was observed in the paracetamol group, though not statistically significant. Infants with a closed ductus arteriosus exhibited higher tissue oxygenation and lower cFTOE.

Conclusions:

  • Paracetamol demonstrated modest hemodynamic effects and increased cerebral oxygenation, primarily attributed to early ductus arteriosus contraction.
  • Potential direct drug effects on the brain cannot be excluded.
Abstract