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

Sanna Juujärvi1,2, Timo Saarela1,2, Mikko Hallman1,2

  • 1PEDEGO Research Unit and MRC Oulu, University of Oulu, Oulu, Finland.

The Journal of Maternal-Fetal & Neonatal Medicine : the Official Journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians
|January 22, 2021
PubMed

Insights

Paracetamol use in very preterm infants appears safe long-term. A five-year follow-up found no increased risks for common adverse effects in infants treated with paracetamol (acetaminophen) shortly after birth.

Area of Science:

  • Neonatal pharmacology and developmental pediatrics.

Background:

  • Paracetamol (acetaminophen) is increasingly used for pain and patent ductus arteriosus in very preterm infants.
  • Limited long-term data exists on the safety of paracetamol exposure in neonates, with some concerns regarding prenatal exposure.

Purpose of the Study:

  • To evaluate the long-term safety of paracetamol administration in very preterm infants.
  • To assess potential adverse consequences up to five years of age following neonatal paracetamol exposure.

Main Methods:

  • A five-year follow-up of a placebo-controlled trial (PreParaS) involving 48 very preterm infants.
  • Utilized a web-based parental questionnaire to gather data on cardiac, respiratory, allergic, neurodevelopmental, and infectious outcomes.
  • Collected information on hospitalizations and medication use.

Main Results:

  • The majority of children in both paracetamol and placebo groups exhibited normal development (79% vs. 65%).
  • Physician-diagnosed asthma, allergies, and respiratory-related hospitalizations were infrequent and not significantly higher in the paracetamol group.
  • Neurological or neuro-psychiatric symptoms were rare in both groups.

Conclusions:

  • Current five-year follow-up data suggests that paracetamol administration shortly after birth is not associated with common adverse outcomes in very preterm infants.
  • The findings may alleviate concerns regarding the short-term use of paracetamol in this vulnerable population.
Abstract

Keywords:
Acetaminophenchild developmentlong-term adverse effectsoutcome assessmentquestionnaire

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