Objective To evaluate the long-term adverse reactions of paracetamol in children who required intensive care shortly after birth. Paracetamol is a widely used analgesic in neonates, but the long-term studies are lacking. Previous epidemiological studies have reported associations between early paracetamol intake and diseases in childhood.
Design Five-year follow-up cohort of children who required intensive care shortly after birth.
Setting Single tertiary care hospital; neonatal and paediatric intensive care units.
Interventions Intravenous paracetamol was administered for pain and discomfort to the neonates during their intensive care, while for the control infants, it was not available.
Main outcome measures The primary outcome was the incidence of asthma; secondary outcomes were neonatal diseases and long-term morbidities (atopic dermatitis, inflammatory bowel disease, autism, speech disorders, cerebral palsy). Long-term morbidities were adjusted based on antenatal and neonatal risk factors.
Results We screened all neonates admitted to the intensive care units soon after birth in Oulu University Hospital, Oulu, Finland, during 1 October 2007 to 31 December 2013. Altogether, 1552 infants needed intensive care. Of them, 735 (47%) were treated with intravenous paracetamol. We obtained their long-term data from the Finnish National Institute for Health and Welfare, including all physician-made diagnoses from all primary healthcare units and hospitals in Finland. We found no difference in the asthma incidence or in other long-term morbidities between paracetamol-treated and non-exposed infants.
Conclusions Intravenous paracetamol given to neonates did not associate with childhood disorders compared with the non-exposed infants during the 5-year follow-up. The previous hypothesis that early paracetamol use causes childhood morbidities was not confirmed.
- intensive care
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Contributors SJ wrote the first draft of the manuscript and collected all the study data. TP supervised the data collection and analysis. OA is the overall corresponding investigator of the project. TS, MH and OA supervised the project and provided the facilities and personnel for the trial. SJ, TP, TS, MH and OA took part in the intellectual content and data analyses. All authors contributed by modifying and editing the manuscript and all approved the final version.
Funding The present study was supported by grants from the Alma and KA Snellman Foundation, Oulu, Finland (OA, SJ), Finnish Medical Foundation (SJ, OA), Foundation for Paediatric Research (OA) and the Sigrid Jusélius Foundation (MH).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The hospital administration, the Office of the Data Protection Ombudsman, Helsinki, Finland, and the National Institute for Health and Welfare, Helsinki, Finland, approved the research plan of this cohort study.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement No data are available. All data relevant to the study are included in the article or uploaded as supplementary information. N/A.