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Comparison of once-daily versus twice-daily gentamicin dosing regimens in infants > or = 2500 g

Ghanshyam Agarwal1, Alok Rastogi, Suma Pyati

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

Journal of Perinatology : Official Journal of the California Perinatal Association
|May 29, 2002
PubMed

Insights

A once-daily gentamicin regimen of 4 mg/kg demonstrated superior peak serum gentamicin concentrations (SGCs) and safe trough levels in neonates compared to a twice-daily regimen. This suggests SGC monitoring may not be necessary for term infants receiving this once-daily dosing for early-onset sepsis.

Area of Science:

  • Neonatal pharmacology
  • Pediatric infectious diseases
  • Clinical pharmacokinetics

Background:

  • Gentamicin dosing regimens for neonates lack standardization.
  • Optimizing gentamicin therapy is crucial for treating bacterial infections in newborns.

Purpose of the Study:

  • To compare the efficacy and safety of a once-daily gentamicin dosing regimen versus a twice-daily regimen in neonates weighing >= 2500 g.
  • To evaluate serum gentamicin concentrations (SGCs) and pharmacokinetic profiles of both dosing regimens.

Main Methods:

  • A prospective, randomized controlled trial involving neonates >= 2500 g treated for suspected bacterial infection.
  • Infants were randomized to receive either 4 mg/kg every 24 hours (study group, n=20) or 2.5 mg/kg every 12 hours (control group, n=21).
  • Serum gentamicin concentrations were monitored, and pharmacokinetic parameters were calculated.

Main Results:

  • The once-daily regimen achieved significantly higher peak SGCs at 30 minutes and steady state (48 hours) compared to the twice-daily regimen (p<0.001).
  • A higher percentage of infants in the once-daily group achieved therapeutic peak SGCs (95% vs. 81% after first dose; higher therapeutic ranges also favored study group).
  • No infants in the once-daily group had elevated trough SGCs requiring dose adjustment, unlike six infants in the control group (p=0.02).

Conclusions:

  • The once-daily gentamicin regimen of 4 mg/kg is effective in achieving higher peak SGCs and safe trough concentrations in neonates compared to the standard twice-daily regimen.
  • Monitoring of SGCs may not be required for term infants with normal renal function receiving a short course of once-daily gentamicin for suspected early-onset sepsis.
Abstract

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