Randomized controlled trial of once vs. twice daily gentamicin therapy in newborn.

ABSTRACT

OBJECTIVE: To compare the efficacy of once daily gentamicin administration to the conventional twice daily dosage schedule by estimation of serum gentamicin concentrations (SGC) in neonates. DESIGN: Randomized controlled trial. SETTING: Medical college hospital. SUBJECTS: Seventy three neonates of gestational age>32 weeks at risk or with clinical features of sepsis. METHODS: The subjects were divided into preterm and term groups. Babies in each of these groups were randomized to receive a single daily dose (4 mg/kg) or a twice daily dose (2.5 mg/kg) of injection gentamicin intravenously. Trough and peak SGC were estimated half an hour prior and one hour after the second dose. Statistical analysis was done using the equivalence method. RESULTS: In preterm as well as term babies, the mean peak and trough gentamicin levels were comparable in the two regimens. There is statistically significant evidence to show that the effect of once daily and twice daily dosage is similar. CONCLUSION: Once daily gentamicin administration is as effective as twice daily therapy and would be more cost effective.