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Excipient exposure in very low birth weight preterm neonates

Journal of Perinatology volume 38, pages 169–174 (2018)Cite this article

Subjects

Abstract

Objective:

The excipients benzyl alcohol, propylene glycol and ethanol are present in medications used in the neonatal intensive care unit. Exposure to high levels can have adverse effects in a neonatal population. The objective was to quantify excipient exposure in very low birth weight (VLBW) neonates and identify risk factors associated with greater exposure.

Study design:

A retrospective record review of VLBW infants admitted over 1 year. Excipient exposures were calculated and multivariable regression analyses identified risk factors for increasing exposure.

Results:

In total, 98% of subjects were exposed to at least one excipient. A total of 5 to 9% received doses higher than recommended for adults. Necrotizing enterocolitis, seizure, bronchopulmonary dysplasia and longer stay predicted higher excipient exposure.

Conclusion:

The excipients examined are in medications commonly prescribed for VLBW neonates, and cumulative doses may exceed recommended exposures for adults. Although safety profiles have not been established, judicious use of medication containing these excipients is warranted for this population.

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Acknowledgements

We gratefully acknowledge the assistance of Dr Nakia Eldridge Pharm. D. and Dr Omayma Kish Pharm. D. who helped with determining excipient concentrations, and Dr. Elizabeth Powell PhD and Dr Rose Viscardi M.D. who gave advice throughout this study. SMM receives funding from NIH: NIAAA AA022413, AA018693, AA006916 and AA017823. CFB receives funding from NIH: NICHD HD085928, HD085061 and the Gerber Foundation. Funding organizations had no role the design of the study, collection and analysis of data or decision to publish.

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Author notes

  1. T O Akinmboni and N L Davis: Co-first author.

Authors and Affiliations

  1. Division of Neonatology, Department of Pediatrics, University of Maryland School of Medicine, Baltimore, MD, USA

    T O Akinmboni, N L Davis, A J Falck, C F Bearer & S M Mooney

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  1. T O Akinmboni
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  2. N L Davis
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  3. A J Falck
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Corresponding author

Correspondence to S M Mooney.

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The authors declare no conflicts of interest.

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Cite this article

Akinmboni, T., Davis, N., Falck, A. et al. Excipient exposure in very low birth weight preterm neonates. J Perinatol 38, 169–174 (2018). https://doi.org/10.1038/jp.2017.165

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