Once daily gentamicin dosing in full term neonates

Area of Science:

• Neonatal pharmacology
• Pediatric infectious diseases
• Clinical pharmacokinetics

Background:

• Current gentamicin dosing recommendations for neonates lack uniformity.
• Gentamicin is a critical antibiotic for treating neonatal sepsis.

Purpose of the Study:

• To compare the efficacy and safety of a once-daily gentamicin dosing regimen versus a twice-daily regimen in term neonates.
• To evaluate serum gentamicin levels (SDL) and the need for dosing adjustments.

Main Methods:

• A comparative study involving 100 term neonates (birth weight >/=2500 g) divided into two groups.
• Control group (n=50): received gentamicin 2.5 mg/kg every 12 hours.
• Protocol group (n=50): received gentamicin 4 mg/kg every 24 hours.
• Trough and peak serum gentamicin levels were measured for all infants.

Main Results:

• The once-daily regimen (4 mg/kg) achieved significantly higher peak SDL (8.4 mg/ml vs. 6.7 mg/ml) compared to the twice-daily regimen (2.5 mg/kg).
• A higher percentage of infants in the once-daily group achieved therapeutic peak SDL (98% vs. 86%) and higher therapeutic range SDL (58% vs. 24%).
• The once-daily regimen resulted in fewer infants with potentially toxic trough SDL (>2 mg/ml) (6% vs. 26%) and required fewer dosing adjustments (12% vs. 40%).

Conclusions:

• A once-daily gentamicin dose of 4 mg/kg is superior to a twice-daily 2.5 mg/kg regimen in term neonates, achieving higher peak and safer trough serum concentrations.
• Serum gentamicin concentration monitoring may not be necessary for once-daily dosing in term infants with suspected sepsis treated for 72 hours.
• This optimized dosing strategy enhances therapeutic outcomes and potentially reduces healthcare resource utilization.