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Comparison of Once-Daily Versus Twice-Daily Gentamicin Dosing Regimens in Infants ≥2500 g

Journal of Perinatology volume 22, pages 268–274 (2002)Cite this article

Abstract

OBJECTIVE: There is no uniformity in the current recommendations of dosing regimen of gentamicin for neonates. We conducted a prospective, randomized, controlled trial to compare a once-daily dosing regimen to the twice-daily dosing regimen for neonates ≥2500 g during the first 7 days after birth.

STUDY DESIGN: Infants ≥2500 g admitted to the Neonatal Intensive Care Unit and prescribed gentamicin for suspected bacterial infection were randomized to receive either 4 mg/kg every 24 hours, study group (n=20), or a standard regimen of 2.5 mg/kg every 12 hours, control group (n=21). Serum gentamicin concentrations (SGCs) were followed and gentamicin pharmacokinetics calculated on all infants.

RESULTS: Peak SGC 30 minutes after the first dose was 8.2±1.7 μg/ml in the study group, compared to 6.4±1.5 μg/ml in the control group (p=0.001). Ninety-five percent of study group infants, compared to 81% of the control group, had peak SGCs in therapeutic range after the first dose. Peak SGC at 48 hours (steady state) was 8.9±1.5 in the study group and 6.8±1.1 in the control group (p=0.0001). On further analysis, a significantly higher percentage of infants in the study group, compared to the control group, had peak SGCs in higher therapeutic ranges of 6 to 12 μg/ml as well as 8 to 12μg/ml. None of the study infants, compared to six control infants, had trough SGCs ≥2 μg/ml at steady state. Thus, none of the study group infants, versus six of the control group infants, needed a dosing adjustment at 48 hours (p=0.02, Fisher's exact test).

CONCLUSION: We found that 4 mg/kg gentamicin given every 24 hours achieved significantly higher peak SGCs and safe trough concentrations in all infants, compared to the twice-daily regimen of 2.5 mg/kg. We suggest that SGCs may not need to be followed in term infants prescribed a short course of this once-daily regimen for suspected early-onset sepsis if renal functions are normal.

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Acknowledgements

We are indebted to DF Kimball, PhD, and his staff from Department of Pathology for performing gentamicin concentrations, and the nursing and medical staff of the NICU, Cook County Hospital, for their assistance in data collection.

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Authors and Affiliations

  1. Department of Pediatrics, Division of Neonatology, Cook County Children's Hospital, Chicago, IL, USA

    Ghanshyam Agarwal MD & Angela Wilks MD

  2. Department of Pediatrics, University of Illinois, Chicago, IL, USA

    Alok Rastogi MD, MRCP

  3. Department of Pediatrics, The Finch University of Health Sciences, The Chicago Medical School, Chicago, IL, USA

    Suma Pyati MD & Rosita S Pildes MD

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  1. Ghanshyam Agarwal MD
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  2. Alok Rastogi MD, MRCP
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  3. Suma Pyati MD
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  4. Angela Wilks MD
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  5. Rosita S Pildes MD
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Presented, in part, at the annual meeting of the Society for Pediatric Research, Boston, MA, May 2000.

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Agarwal, G., Rastogi, A., Pyati, S. et al. Comparison of Once-Daily Versus Twice-Daily Gentamicin Dosing Regimens in Infants ≥2500 g. J Perinatol 22, 268–274 (2002). https://doi.org/10.1038/sj.jp.7210704

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