University of Oulu

Sanna Juujärvi, Timo Saarela, Mikko Hallman & Outi Aikio (2021) Trial of paracetamol for premature newborns: five-year follow-up, The Journal of Maternal-Fetal & Neonatal Medicine, DOI: 10.1080/14767058.2021.1875444

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

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Author: Juujärvi, Sanna1,2; Saarela, Timo1,2; Hallman, Mikko1,2;
Organizations: 1PEDEGO Research Unit and MRC Oulu, University of Oulu, Oulu, Finland
2Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland
Format: article
Version: published version
Access: open
Online Access: PDF Full Text (PDF, 0.8 MB)
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Language: English
Published: Informa, 2021
Publish Date: 2022-03-16


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.

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Series: Journal of maternal-fetal & neonatal medicine
ISSN: 1476-7058
ISSN-E: 1476-4954
ISSN-L: 1476-7058
Volume: In press
DOI: 10.1080/14767058.2021.1875444
Type of Publication: A1 Journal article – refereed
Field of Science: 3123 Gynaecology and paediatrics
Funding: The present study was supported by the grants from the Alma and K.A. Snellman Foundation, Oulu, Finland (OA, SJ), the Finnish Medical Foundation (SJ, OA), the Foundation for Pediatric Research (OA, SJ), and the Sigrid Jusélius Foundation (MH).
Copyright information: © 2021 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License (, which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited, and is not altered, transformed, or built upon in any way.