University of Oulu

Juujärvi, S. , Kallankari, H. , Pätsi, P. , Leskinen, M. , Saarela, T. , Hallman, M. and Aikio, O. (2019), Follow‐up study of the early, randomised paracetamol trial to preterm infants, found no adverse reactions at the two‐years corrected age. Acta Paediatr, 108: 452-458. doi:10.1111/apa.14614

Follow-up study of the early, randomised paracetamol trial to preterm infants, found no adverse reactions at the two-years corrected age

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Author: Juujärvi, S.1,2; Kallankari, H.1,2; Pätsi, P.1,2;
Organizations: 1PEDEGO Research Center and MRC Oulu, University of Oulu, Oulu, Finland
2Department of Children and Adolescents, Oulu University Hospital, Oulu, Finland
Format: article
Version: accepted version
Access: embargoed
Persistent link: http://urn.fi/urn:nbn:fi-fe2019070422765
Language: English
Published: John Wiley & Sons, 2019
Publish Date: 2020-03-31
Description:

Abstract

Aim: We examined the long‐term outcomes and safety of early intravenous paracetamol for ductus arteriosus closure at a corrected age of two years.

Methods: This was a follow‐up of the 2013–2014 randomised, double‐blind Preterm Infant’s Paracetamol Study at Oulu University Hospital, Finland, which recruited 48 very preterm infants within 24 hours of birth. They received intravenous paracetamol or a placebo for four days. In 2015–2017, we followed up 44 infants (92%) at two years of corrected age. This included clinical and neurodevelopmental assessments and a parental medical history questionnaire.

Results: The 44 infants (55% boys) were born at 235–316 weeks of gestation. No differences in the cardiac parameters, including blood pressures and ultrasound scan results, were found. Neurodevelopmental stages, as quantified by the Griffiths test, were similar. No signs of autism were reported. Asthma medication was more common in the control group, but the difference was not significant. Atopy scores, numbers of infections and the use of public health services were similar between the two groups.

Conclusion: No long‐term adverse reactions of early intravenous paracetamol were detected two years later. Larger trials are needed on the safety and efficacy of paracetamol prophylaxis for early ductal closure in very preterm infants.

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Series: Acta pædiatrica
ISSN: 0803-5253
ISSN-E: 1651-2227
ISSN-L: 0803-5253
Volume: 108
Issue: 3
Pages: 452 - 458
DOI: 10.1111/apa.14614
OADOI: https://oadoi.org/10.1111/apa.14614
Type of Publication: A1 Journal article – refereed
Field of Science: 3123 Gynaecology and paediatrics
Subjects:
Funding: This work was supported by the grants from Finnish Medical Foundation, Foundation for Pediatric Research, Alma and K.A. Snellman Foundation, and Sigrid Jusélius Foundation.
Copyright information: © 2018 Foundation Acta Pædiatrica. Published by John Wiley & Sons Ltd 2019. This is the peer reviewed version of the following article: Juujärvi, S. , Kallankari, H. , Pätsi, P. , Leskinen, M. , Saarela, T. , Hallman, M. and Aikio, O. (2019), Follow‐up study of the early, randomised paracetamol trial to preterm infants, found no adverse reactions at the two‐years corrected age. Acta Paediatr, 108: 452-458. doi:10.1111/apa.14614, which has been published in final form at https://doi.org/10.1111/apa.14614. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Self-Archiving.