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Extended Interval Dosing of Gentamicin in Neonates

Recruitingn/aAges 0 Days - 7 DaysAllLondon Health Sciences Centre Research Institute …
NCT07460349 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 b

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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
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What it tests

  • 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
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Where

1 site
Children's Hospital: London Health Sciences Centre
London, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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