Use of Higher Dose Extended Interval Aminoglycosides in a Neonatal Intensive Care Unit

Abstract

The objective of this study is to determine the safety and efficacy of an extended interval aminoglycoside dosing guideline implemented in our neonatal intensive care unit (NICU). A retrospective review of pharmacokinetic data on 44 patients led to the development of an extended interval aminoglycoside guideline utilizing a 5-mg/kg dose given at an interval based on postconceptional age and risk factors that may alter aminoglycoside clearance. After implementation of the new clinical guideline, a retrospective review of patient records was performed. Thirty-six of 43 peak levels were within the goal range. Trough levels were <1 microg/mL in 41 of 46 patients, with no trough >2 microg/mL. Thirty-three patients had clinical or culture proven sepsis and were successfully treated with the new regimen. No difference between pre- and post-treatment blood urea nitrogen (BUN) and serum creatinine values was observed. Hearing evaluations were performed in 32 patients with one failure. The patient who failed the hearing screen, passed a follow-up hearing test. Three deaths, none attributed to infection or the drug, occurred during the evaluation period. The dosing guidelines developed for our NICU patients are safe and effective, although evaluation of the longterm potential for ototoxicity should be performed.

Gentamicin extended interval regimen and ototoxicity in neonates

“…Our results are in agreement with different previous studies which showed that hearing loss is a rare complication of gentamicin therapy [23][24][25][26] even when infants were followed up to 3 and 5 years of age [27].…”

A simple, weight-based, extended-interval gentamicin dosage protocol for neonates

“…All the comparative studies did show EID protocols to be superior to MDD protocols in providing fewer elevated troughs, fewer subtarget peaks, and fewer dosage adjustments when these were reported. [15][16][17][18][19][20][21][22]24 With respect to these three elements, our protocol produced similar results. The percentage of patients requiring dosage adjustments in these studies ranged from 0% to 13%, compared with 7% in our evaluation.…”

“…Since the 1998 survey, 14 several viable options have been evaluated; however, no clear consensus exists as to the optimal dosage regimen for neonates. [15][16][17][18][19][20][21][22] With only a few clinical trials directly comparing these protocols, 23 clinicians must decide which protocols might best fit the needs of their patient population and institution.…”

Vestibular system in infants after systemic aminoglycoside therapy

“…Aminoglycosides are, nevertheless, routinely used for treatment of vital infections of in neonatologic departments. Chief indications are sepsis and severe respiratory tract infection with blood urea nitrogen and serum creatinine values monitored and hearing evaluations performed in order to lower the risk of side effects [5,[9][10][11][12].…”