35 neonates (mean gestational age: 34.9 +/- (SD) 3.5 weeks; mean birth weight: 2,180 +/- 890 g) treated with amikacin were examined for possible ototoxicity and nephrotoxicity. Audiometric tests were performed at 14.2-30.0 months postconceptional age by cross-checking behavioural with brain stem-evoked response audiometry. Only 1 infant was found with a mild hearing loss with brain stem audiometry, which, however, could not be attributed to amikacin with certainty. The effect of the aminoglycoside on the kidney was studied both by monitoring serum creatinine and the urinary elimination of the lysosomal enzyme N-acetylglucosaminidase (NAG). No significant difference was found in serum creatinine between the group under investigation and a control group of untreated premature neonates. A transient elevation was found in NAG urinary excretion in the neonates treated with amikacin. These results lead to the conclusion that amikacin at the recommended dosages (7.5 mg/kg every 12 h) causes a subclinical and reversible tubular damage in the neonate despite the high serum concentrations of the drug. The clinical relevance of this finding is discussed.

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