GENT-le Dosing: Evaluating the Safety of Gentamicin at Higher Doses for Late Preterm and Term Neonates
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Publication Date
4-29-2026
Keywords
oregon, psvmc, psvmc gme, psvmc gme pharmacy
Disciplines
Medical Education
Abstract
Abstract: In June 2024, Providence St Joseph Health updated the standard gentamicin dose in the Pediatric and Neonatal Aminoglycoside protocol from 4 mg/kg to 5 mg/kg every 24 hours for late preterm and term neonates. This project aims to evaluate late preterm and term neonatal patients who received gentamicin for empiric sepsis coverage within the first seven days of life, at 4 mg/kg/dose or 5 mg/kg/dose, to assess the safety of the standardized 5 mg/kg dosing for late preterm and term neonates after the protocol change. This study is a multicenter retrospective pre-/post-intervention analysis at a multistate health system spanning 51 hospitals. Term neonatal patients who received either 4 mg/kg/dose every 24 hours or 5 mg/kg/dose every 24 hours for empiric sepsis will be included. Further inclusion criteria include receipt of at least one dose of gentamicin, gestational age of at least 35 weeks, and delivery at a hospital within the Providence St Joseph Health system. The pre-intervention group will include patients who meet inclusion criteria that were born from October 1, 2022, through September 30, 2023, while the post-intervention group will include qualifying patients born from October 1, 2024 to September 30, 2025. Primary endpoints include urine output and urine occurrences per 24 hours for a 4-day period following the first dose of gentamicin. Secondly, endpoints include daily serum creatinine values when available and duration of gentamicin dosing. Serum gentamicin levels are not routinely collected in this patient population, as duration of therapy is often limited, and standard practice is to avoid drawing blood when not entirely necessary. For patients who received gentamicin long enough to warrant drawing a trough and/or peak, a subgroup analysis will be performed to evaluate if the higher dosing regimen resulted in significantly higher levels. This will be evaluated not only based on numeric serum concentration values reported but also based on the incidence of sub- and supra-therapeutic levels. Descriptive statistics will be used to describe the baseline characteristics of the study population. A p-value of less than 0.05 will be considered statistically significant. Results and Conclusions will be reported and shared when the project is complete. (IRB approved) Learning Objectives: Describe the difficulties of gentamicin dosing in late preterm and term neonates. Evaluate the safety of gentamicin when dosed at 4 mg/kg/dose vs 5 mg/kg/dose for late preterm and term neonates. Presentation Category: Pediatrics and Neonates
Specialty/Research Institute
Graduate Medical Education
Specialty/Research Institute
Pharmacy
