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2% aqueous vs alcohol-based chlorhexidine for skin antisepsis in VLBW neonates undergoing peripheral venipuncture: a non-inferiority trial

Journal of Perinatology volume 42, pages 636–641 (2022)Cite this article

Subjects

Abstract

Objective

To compare 2% aqueous chlorhexidine gluconate (AQC) vs. 2% chlorhexidine gluconate in 70% isopropyl alcohol (ALC) for pre-venipuncture skin antisepsis in very-low-birth-weight neonates (VLBW, birth-weight <1500 grams).

Study design

Double-blind, non-inferiority trial randomized 199 VLBW neonates, age 2–28 days, to receive pre-venipuncture skin preparation using single application of swabstick impregnated with AQC (n = 99) or ALC (n = 100). Skin clearance rate (percentage post-cleansing skin swabs with <15 bacterial colony forming units) with a 10% non-inferiority margin for AQC was primary outcome. Absolute and relative CFU reduction and adverse skin reactions were compared.

Results

AQC’s clearance was non-inferior to ALC (91% vs. 88%; 95% CI −6.6%, +12.4%). Median (interquartile range) absolute [61 (16, 110) vs. 63 (18, 100); p = 0.65] and relative [100% (97%, 100%) vs. 100% (99.7%, 100%); p = 0.20] CFU reductions were similar. Neither group experienced any adverse reactions.

Conclusion

AQC may provide non-inferior skin disinfection to ALC in VLBW neonates.

Clinical Trial registration

ClinicalTrials.gov NCT01270776.

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Fig. 1: Patient trial flowchart.

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Data availability

Individual de-identified participant data that underlie the results reported in this manuscript and the study protocol will be available, pending approval by the institutional research ethics board, immediately following publication, for investigators who provide a methodologically sound proposal approved by an independent review committee, to achieve aims cited in the approved proposal. Data request and proposals should be directed to the corresponding author. Requestors will need to sign a data sharing agreement.

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Funding

The authors (AJ, VS) received peer-reviewed operating grant from the Physicians’ Services Incorporated (PSI) Foundation, Ontario, Canada, which supported all phases of this study. The funding agency had no role in study design, collection, analysis or interpretation of data, writing this manuscript or the decision to submit it for publication.

Author information

Authors and Affiliations

  1. Department of Paediatrics, University of Toronto, Toronto, Canada

    Amish Jain, Poorva Deshpande & Vibhuti Shah

  2. Maternal and Infant Care Research Center (MiCare), University of Toronto, Toronto, Canada

    Eugene W. Yoon

  3. Division of Neonatology, the Hospital for Sick Children, Department of Paediatrics, University of Toronto, Toronto, Canada

    Kyong-Soon Lee

  4. Microbiology, Mount Sinai Hospital, University of Toronto, Toronto, Canada

    Allison McGeer

Authors
  1. Amish Jain
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  2. Poorva Deshpande
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  4. Kyong-Soon Lee
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  5. Allison McGeer
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  6. Vibhuti Shah
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Contributions

AJ designed and conceptualized the study, obtained the operating grant to support the study, carried out study procedures, coordinated and assisted in patient recruitment, supervised data collection, prepared the initial draft of the manuscript, and reviewed and revised the final manuscript. PD contributed in designing the study, carried out study procedures, coordinated and assisted in patient recruitment and data collection, and reviewed and revised the final manuscript. WY assisted by designing the statistical section of the study proposal, contributed in the successful grant proposal to obtain operating funds, conducted the interim as well as the final analysis for the study, and reviewed and revised the final manuscript. KSL was the site investigator for the secondary study site. KSL was directly responsible for obtaining local approvals, and coordinating and supervising recruitment and data collection at secondary study site, and reviewed and revised the final manuscript. AM contributed by designing the microbiology methodology for the study proposal as well as for the successful grant proposal to obtain operating funds, supervised microbiology staff in analyzing and reporting study specimens, and reviewed and revised the final manuscript. VS designed and conceptualized the study, obtained the operating grant to support the study, provided overall senior supervision in the day-to-day conduct of the study, and reviewed and revised the final manuscript. All authors approved the final manuscript as submitted and agree to be accountable for all aspects of the work.

Corresponding author

Correspondence to Amish Jain.

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Competing interests

The authors declare no competing interests.

Ethics approval

The study was approved by institutional research ethics board at both study sites and informed consent was obtained from all participants before inclusion.

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Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

The study was presented at an abstract at the Pediatric Academic Society’s (PAS) annual conference, 2014.

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Jain, A., Deshpande, P., Yoon, E.W. et al. 2% aqueous vs alcohol-based chlorhexidine for skin antisepsis in VLBW neonates undergoing peripheral venipuncture: a non-inferiority trial. J Perinatol 42, 636–641 (2022). https://doi.org/10.1038/s41372-022-01337-1

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  • DOI: https://doi.org/10.1038/s41372-022-01337-1

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