Extended Interval Dosing of Gentamicin in Neonates

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-7
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Standard of care administration of gentamicin dosed at 3 mg/kg every 24 hours
  • Standard of care administration of gentamicin dosed at 3.5 mg/kg every 24 hours

Treatment groups

42 Participants
are divided into 2 treatment groups