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Long-term safety of prenatal and neonatal exposure to paracetamol: a protocol for a systematic review
Samira Samiee-Zafarghandy1, Katelyn Sushko2, John Van Den Anker3,4
1Department of Pediatrics, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.
Insights
This systematic review examines the long-term safety of paracetamol (acetaminophen) in newborns following prenatal and neonatal exposure. It aims to consolidate evidence on potential adverse events for better clinical guidance.
Area of Science:
- Neonatal pharmacology and toxicology
- Evidence synthesis and systematic reviews
- Pediatric long-term health outcomes
Background:
- Increasing use of paracetamol in neonates raises safety concerns.
- Potential for long-term adverse events from prenatal and neonatal paracetamol exposure.
- Need for a comprehensive review of existing evidence.
Approach:
- Systematic review following Joanna Briggs Institute and PRISMA guidelines.
- Comprehensive literature search across Embase, MEDLINE, Web of Science, and Google Scholar.
- Inclusion of studies regardless of language or design, with rigorous risk of bias assessment.
Key Points:
- Focus on long-term adverse events in infants exposed to paracetamol.
- Systematic synthesis of data from diverse study designs.
- Quality assessment to ensure reliability of findings.
Conclusions:
- This review will provide critical insights into the long-term safety profile of neonatal paracetamol exposure.
- Findings will inform clinical practice and future research directions.
- Dissemination through peer-reviewed publications and scientific conferences.
Introduction:
A surge in the use of paracetamol in neonates has resulted in growing concerns about its potential long-term adverse events. In this study, we conduct a systematic review of the long-term safety of prenatal and neonatal exposure to paracetamol in newborn infants.
Methods And Analysis:
We will follow the Joanna Briggs Institute Manual for Evidence Synthesis and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statements to conduct and report this review. We will conduct a systematic search of Embase, MEDLINE, Web of Science and Google Scholar for studies with data on long-term adverse events in neonates that were exposed to paracetamol in the prenatal and/or neonatal period. We will not apply language or design limitations. We will use standardised risk of bias assessment tools to perform a quality assessment of each included article.
Ethics And Dissemination:
This systematic review will only involve access to publicly available data, and therefore ethical approval will not be required. The results of this study will be communicated to the target audience through peer-reviewed publication as well as other knowledge exchange platforms, such as conferences, congresses or symposia.
Trial Registration:
The protocol for this systematic review is submitted for registration to international database of prospectively registered systematic reviews (PROSPERO, awaiting registration number).
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