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NOT YET RECRUITING
NCT07460349

Extended Interval Dosing of Gentamicin in Neonates

Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

View on ClinicalTrials.gov

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.

Official title: Extended Interval Dosing of Gentamicin in Neonates to Achieve Target Drug Concentrations

Key Details

Gender

All

Age Range

0 Days - 7 Days

Study Type

OBSERVATIONAL

Enrollment

42

Start Date

2026-03

Completion Date

2026-05

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

OTHER

Standard of care administration of gentamicin dosed at 3 mg/kg every 24 hours

No 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.

OTHER

Standard of care administration of gentamicin dosed at 3.5 mg/kg every 24 hours

No 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.

Locations (1)

Children's Hospital: London Health Sciences Centre

London, Ontario, Canada