A previous pharmacy residency project was done 20 years ago looking at the best dosing for the antibiotic gentamicin for babies up to 7 days old. This study showed that giving the dose less often leads to better drug concentrations than giving the dose more often. Our gentamicin dosing at the Children's Hospital at London Health Sciences Centre is based on the better dosing from the study. This dosing is gentamicin 3 mg/kg every 24 hours for babies less than 35 weeks gestational age and 3.5 mg/kg every 24 hours for babies at least 35 weeks gestational age. These results were never published. Different dosing is used at different hospitals. It is important that we check that our gentamicin dosing is still reaching safe and effective drug concentrations in the current study. The study will look at the gentamicin drug concentrations of babies up to 7 days old, including premature and term babies. We will also confirm if the babies have kidney or hearing damage from gentamicin. We will compare the gentamicin drug concentrations from this study to the past data to see if the dosing is still the best. The results can help form a guideline for the Children's Hospital and surrounding hospitals.
Neonates up to 7 days of age,
Neonate must be on gentamicin, and
Gentamicin trough and peak levels must be available for the third dose of gentamicin.
Incorrect dose for weight (+/- 10% allowed to account for dose rounding)
Multiple levels from the same patient; only the first set of levels will be collected
Baseline renal dysfunction (e.g. congenital kidney disease)
On other nephrotoxic or ototoxic drugs concurrently with the first 3 days of gentamicin
Neonates admitted to the Neonatal Intensive Care Unit, Paediatric Critical Care Unit (PCCU), or Paediatrics Unit (B6) at the Children's Hospital, London Health Sciences Centre
Cohort
Prospective
Standard of care administration of gentamicin dosed at 3 mg/kg every 24 hours
Other interventionNo interventions will be made to the neonates. Standard of care will be followed with empiric gentamicin and levels ordered for the neonates at the discretion of the medical team.
Standard of care administration of gentamicin dosed at 3.5 mg/kg every 24 hours
Other interventionNo interventions will be made to the neonates. Standard of care will be followed with empiric gentamicin and levels ordered for the neonates at the discretion of the medical team.
Trough gentamicin levels
The primary objective is to measure and monitor the number of trough gentamicin levels within target range \< 2 mg/L with the current extended interval dosing regimen compared to traditional dosing in neonates ≤ 7 days of age.
Peak gentamicin levels
Maintain peak gentamicin levels within target range (6-10 mg/L)
Incidence of suspected nephrotoxicity
Monitor the incidence of suspected nephrotoxicity (serum creatinine \> 53 umol/L, Blood Urea Nitrogen (BUN) \> 10 mmol/L, and urine output \< 1 mL/kg/h)
Incidence of suspected ototoxicity
Monitor the incidence of suspected ototoxicity (failed on newborn hearing screening) in different dosing regimens. Newborn hearing screening tests follow electrophysiological methods with automated distortion product otoacoustic emissions and automated auditory brainstem response
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