Determination of extended-interval gentamicin dosing for neonatal patients in developing countries

Background: Infectious diseases account for an estimated 36% of neonatal deaths globally. The purpose of this study was to determine safe, effective, simplified dosing regimens of gentamicin for treatment of neonatal sepsis in developing countries. Methods: Neonates with suspected sepsis in the neonatal intensive care unit (NICU) at Christian Medical College and Hospital (CMC), Vellore, India (n = 49), and Dhaka Shishu Hospital (DSH), Bangladesh (n = 59), were administered gentamicin intravenously according to the following regimens: (1) 10 mg every 48 hours for neonates < 2000 g; (2) 10 mg every 24 hours for neonates 20002249 g; and (3) 13.5 mg every 24 hours for neonates >= 2500 g. Serum gentamicin concentration (SGC) at steady state and pharmacokinetic indices were determined. Renal function was followed while under treatment and hearing was examined 6 weeks to 3 months after discharge. Results: All neonates, except 1 weighing 2000-2249 g at DSH, had a peak SGC >4 mu g/mL. Overall, 5 (10%) and 17 (29%) infants had a peak SGC level >= 12 mu g/mL from CMC and DSH, respectively, and 10 (20%) and 4 (7%) cases from CMC and DSH, respectively, had a trough SGC level >= 2 mu g/mL. However, no infant < 2000 g had a trough SGC level >= 2 mu g/mL. We found no evidence of gentamicin nephrotoxicity or ototoxicity. Conclusion: Safe, therapeutic gentamicin dosing regimens were identified for treatment of neonatal sepsis in developing country settings. Administration of these doses could be simplified through use of Uniject, a prefilled, single injection device designed to make injections safe and easy to deliver in developing country settings.