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Life sciences · Observational Study
ClinicalTrials.gov · October 1, 2026
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Observational Study.
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Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07460349). This is a study registration, not published results. Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 42 participants (ESTIMATED). Conditions: Early Onset Sepsis. Interventions: OTHER: Standard of care administration of gentamicin dosed at 3 mg/kg every 24 hours; OTHER: Standard of care administration of gentamicin dosed at 3.5 mg/kg every 24 hours. Primary outcome measures: Trough gentamicin levels , Day 3 of treatment: prior to the third gentamicin dose. Brief summary: 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.