Extended Interval Dosing of Gentamicin in Neonates

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.

NCT Number	NCT07460349
Lead Sponsor	London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Conditions	Early Onset Sepsis
Enrollment	42 participants
Start Date	2026-06
Primary Completion	2026-12 (estimated)
Study Completion	2027-04 (estimated)
Updated on ClinicalTrials.gov	2026-06-09