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 2000–2249 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 μg/mL. Overall, 5 (10%) and 17 (29%) infants had a peak SGC level ≥12 μg/mL from CMC and DSH, respectively, and 10 (20%) and 4 (7%) cases from CMC and DSH, respectively, had a trough SGC level ≥2 μg/mL. However, no infant <2000 g had a trough SGC level ≥2 μg/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.
From the *Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD; Departments of †Neonatology and §Microbiology, Institute of Child Health, Dhaka Shishu Hospital, Dhaka, Bangladesh; Department of ‡Neonatology, Christian Medical College and Hospital, Vellore, India; ∥Department of Pharmacology, Duke University, Durham, NC; ¶Department of Pharmacy Practice, Wayne State University; #NIH/NICHD Pediatric Pharmacology Research Unit Network, Children's Hospital of Michigan, Wayne State University, Detroit, MI; and **PATH, Seattle, WA.
Accepted for publication March 9, 2007.
Address for correspondence: Gary L. Darmstadt, MD, MS, Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD. E-mail: email@example.com.