Article Text

Download PDFPDF

Long-term safety of prenatal and neonatal exposure to paracetamol: a protocol for a systematic review
  1. Samira Samiee-Zafarghandy1,
  2. Katelyn Sushko2,
  3. John Van Den Anker3,4
  1. 1Department of Pediatrics, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
  2. 2School of Nursing, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada
  3. 3Division of Clinical Pharmacology, Children's National Hospital, Washington, DC, USA
  4. 4Division of Paediatric Pharmacology and Pharmacometrics, University Children’s Hospital Basel, University of Basel, Basel, Switzerland
  1. Correspondence to Dr Samira Samiee-Zafarghandy; samiees{at}


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).

  • neonatology
  • pharmacology

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:

Statistics from


  • Contributors SS-Z and JVDA contributed to the conception and design of the protocol and its scientific writing. All authors contributed to the critical review of the protocol and review of its scientific content. All authors give final approval on the version to be submitted.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study will be included in the article or will be uploaded as supplementary information.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.