Gentamicin dosing in neonates: checking if extended-interval dosing still works

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects current gentamicin trough and peak levels from neonates up to 7 days old who are treated with either 3 mg/kg every 24 hours or 3.5 mg/kg every 24 hours. It compares these results with historic dosing data from the same center to see if target drug concentrations are being reached. The study also screens for kidney or hearing effects that could be related to gentamicin exposure. Enrollment relies on standard care administration and uses a letter of information with parental consent where appropriate. Findings could inform whether the current dosing guidelines remain appropriate and whether formal updates or guidelines are needed for local practice.

Why it matters

Who can join: the full rules

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

Where it's running

• Children's Hospital: London Health Sciences Centre
  London, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Venita Harris, PharmD — London Health Sciences Centre
• Study coordinator: Sarah H.P. Vo, PharmD
• Email: sarah.vo@lhsc.on.ca
• Phone: 519-685-8500

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Shorter ampicillin course for preterm infants with early onset sepsis

  This study tests whether stopping ampicillin at 24–36 hours is safe and provides enough drug exposure in preterm babies who are already getting the medicine.

  Recruiting Phase 1/2 Duke University · Durham, North Carolina · NCT07610486

• Optimizing antibiotic choices for newborns with suspected early-onset sepsis

  This project will try three proven hospital approaches—the EOS calculator, procalcitonin-guided therapy, and switching from IV to oral antibiotics—to reduce unnecessary antibiotic use in newborns born at 34+ weeks who are 0–3 days old with suspected early-onset sepsis.

  Recruiting at 11 sites Franciscus Gasthuis · Alkmaar and 10 other locations · NCT06845332

• Renal Nerve Stimulation to Help Blood Pressure in AF and HFpEF

  This study tests whether stimulating the kidneys with a catheter can safely lower blood pressure in adults with atrial fibrillation and HFpEF who also have hypertension.

  Recruiting London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario · NCT07893821

• Intraoperative diuretics during deceased-donor kidney transplants

  This trial tests whether using furosemide or mannitol during kidney transplant surgery affects delayed graft function in adults receiving a deceased-donor kidney.

  Recruiting London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario and 1 other locations · NCT07726134

• Faster brain stimulation for PTSD and depression

  This pilot study tests a quicker brain stimulation schedule (accelerated iTBS) to see if it’s doable, safe, and tolerable for adults with PTSD and major depression.

  Recruiting London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario · NCT07682207

• Bladder Management and Quality of Life in Young Adults with Spina Bifida

  This study asks teens and young adults with spina bifida how different bladder care methods affect their daily life and happiness.

  Recruiting London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario · NCT07642466

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.