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Once daily gentamicin dosing in full term neonates
1Department of Pediatrics, King Abdul-Aziz University Hospital, PO Box 80215, Jeddah, 21589, Kingdom of Saudi Arabia. salsaedi@hotmail.com
Insights
Once-daily gentamicin (4 mg/kg) is more effective and safer than twice-daily dosing (2.5 mg/kg) in term neonates. This optimized gentamicin regimen may reduce the need for serum drug level monitoring in infants with suspected sepsis.
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.
Objective:
There is no uniformity in the current recommendations of dosing regimen of gentamicin for neonates. We conducted this study to compare once-daily dosing regimen to the twice-daily dosing regimen for neonates with birth weight of >/=2500 g during the first 7 days of life.
Methods:
Fifty full term infants with birth weight of >/=2500 gm admitted to the neonatal intensive care unit of King Abdul-Aziz University Hospital, Jeddah, Kingdom of Saudi Arabia between November 1999 to October 2000 and received gentamicin at a dose of 2.5 mg/kg every 12 hours (control group) were compared with 50 term infants who received gentamicin at dose of 4 mg/kg every 24 hours during the period of November 2000 until October 2002 (protocol group). Trough and peak serum gentamicin levels (SDL) were measured on all infants.
Results:
Peak SDL was 8.4 +/- 1.8 mg/ml in the protocol group, compared to 6.7 +/- 2 mg/ml in the control group (p=0.001). Ninety-eight percent (n=49) of the protocol group, compared to 86% (n=43) of the control group, had peak SDL in therapeutic range. Fifty-eight percent (n=29) of infants in the protocol group, compared to 24% (n=12) of infants in the control group, had peak SDL in higher therapeutic range of 8-12 mg/ml. Six percent (n=3) of the protocol infants, compared to 26% (n=13) of the control infants, had trough SDL >2 mg/ml. Six infants (12%) in the protocol group, versus 20 infants (40%) of the control group, required a dosing adjustment.
Conclusion:
Gentamicin dose of 4 mg/kg given at 24-hour interval achieved significantly higher peak and safe trough serum concentrations in term infants, compared to the twice-daily regimen of 2.5 mg/kg. We suggest that measurement of gentamicin concentration may be not required when once-daily regimen is prescribed for 72 hours to term infants with suspected sepsis.