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

Abstract

Introduction: 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.

Patients and methods: A five-year follow-up study of a placebo-controlled paracetamol trial on very preterm infants (PreParaS) was conducted (n = 48). Using a web-based parental questionnaire, parents answered questions about their children's cardiac and respiratory symptoms, allergies, neurodevelopment, infections, medications and hospitalizations.

Results: 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.

Conclusions: 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.

Keywords: Acetaminophen; child development; long-term adverse effects; outcome assessment; questionnaire.