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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 48 participants or records.
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