Trial of paracetamol for premature newborns : five-year follow-up

Abstract

<div lang="en" class="abs"><p class="abs_header">Abstract</p><p><em>Introduction:</em> Paracetamol is a commonly used pain medication for the very-high risk neonates and it is increasingly being used for patent ductus arteriosus treatment in preterm infants. However, randomized trial data on long-term consequences are not yet available, but there is some evidence of serious adverse effects on children exposed to paracetamol during pregnancy.</p><p><em>Patients and methods:</em> A five-year follow-up study of a placebo-controlled paracetamol trial on very preterm infants (PreParaS) was conducted (<em>n</em> = 48). Using a web-based parental questionnaire, parents answered questions about their children’s cardiac and respiratory symptoms, allergies, neurodevelopment, infections, medications and hospitalizations.</p><p><em>Results:</em> Most parents reported that their child had normal development (paracetamol 79% vs. placebo 65%). Physician-diagnosed asthma or allergy (paracetamol 10.5% vs. placebo 25.0%), or hospitalization due to respiratory symptoms (0 vs. 15%) were uncommon and neurological or neuro-psychiatric symptoms were rare.</p><p><em>Conclusions:</em> Current follow-up results on paracetamol-exposed very preterm infants may not be alarming suggesting that paracetamol administration shortly after birth is not associated with common adverse consequences.</p></div>