NCT07460349 Extended Interval Dosing of Gentamicin in Neonates
| NCT ID | NCT07460349 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Early Onset Sepsis |
| Study Type | OBSERVATIONAL |
| Enrollment | 42 participants |
| Start Date | 2026-06-17 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 42 participants in total. It began in 2026-06-17 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Venita Harris, PharmD
PRINCIPAL INVESTIGATOR
London Health Sciences Centre
Frequently Asked Questions
Who can join the NCT07460349 clinical trial?
This trial is open to participants of all sexes, aged 0 Days or older, up to 7 Days, studying Early Onset Sepsis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07460349 currently recruiting?
Yes, NCT07460349 is actively recruiting participants. Contact the research team at sarah.vo@lhsc.on.ca for enrollment information.
Where is the NCT07460349 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT07460349 clinical trial?
NCT07460349 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Venita Harris, PharmD at London Health Sciences Centre. The trial plans to enroll 42 participants.