Extended Interval Dosing of Gentamicin in Neonates
Recruiting now
Conditions studied: Early Onset Sepsis
In brief
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.
Key facts
- Study ID
- NCT07460349
- Run by
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- People needed
- 42
- Starts
- 2026-06-01
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-06-09
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Children's Hospital: London Health Sciences Centre — London, Ontario, Canada (enrolling)
Full record on ClinicalTrials.gov
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