Objective: Gentamicin dosing is highly variable and remains complicated in the neonatal population. Traditional dosing in our unit resulted in an excessive number of elevated trough serum gentamicin levels. We hypothesized that one uniform gentamicin dose for neonates of all gestational ages will reduce the incidence of elevated trough levels from 50 to 10%.
Study design: Our prospective, randomized, controlled trial enrolled eligible neonates into two groups, according to gestational age (⩽34 6/7 (group I) and >35 0/7 weeks (group II)). Patients in the study arm received a dose of gentamicin 5 mg kg(-1) intravenous (i.v.) every 36 h, whereas patients in the control arm received traditional dosage. Patients were monitored for resolution of infection, serum gentamicin levels and adverse effects. We confirmed our findings in a follow-up study. Fisher's exact and Mann-Whitney tests were used for statistical analysis.
Results: We enrolled 96 neonates, 50 in group I (n=25 per arm) and 46 in group II (n=23 per arm). Elevated trough levels were reduced by 66% in group I (P=0.61) and 100% in group II (P=0.0015). In the study arm of both groups, 48/49 neonates had Cmin serum gentamicin concentration (SGC) <2 mg l(-1) and the majority had a trough SGC <1 mg l(-1) (P<0.0001). The study dose resulted in maximum gentamicin levels in the goal range and a 50% reduction in dosage modifications. There were no treatment failures or adverse effects. Our follow-up study phase confirmed these results.
Conclusion: A standardized gentamicin dosage of 5 mg kg(-1) i.v. every 36 h to neonates of all gestational ages was safe and resulted in SGCs in goal therapeutic ranges. The implications of this simplified gentamicin dosage are to reduce health-care costs by less frequent dosing of gentamicin and reducing medication errors in physician prescribing from complicated dosing schemes.