NCT07460349

Extended Interval Dosing of Gentamicin in Neonates

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 42 (estimated)
• Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · Academic / Other
• Sex: All
• Age: 0 Days – 7 Days
• Healthy volunteers: Not accepted

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.

Detailed description

Current gentamicin dosing at the Children's Hospital is based on the previous projects completed at LHSC. Different gentamicin dosing recommendations exist depending on the reference used. This study would help validate if the current extended interval dosing in neonates is still achieving target gentamicin concentration levels. We will compare the results of the current study to our historic data. The results will help determine if infants are receiving effective and safe treatment with gentamicin. Depending on the results of the study, further evaluation on changes to gentamicin dosing may be needed or an official guideline may be published if gentamicin levels are being adequately achieved with the current dosing. This official guideline will help prescribers at the Children's Hospital and hospitals in the surrounding region that will adopt our dosing when treating infants. There will be an overall benefit to prescribers and patients ensuring safe and effective of gentamicin dosing is followed. An exemption for consent is being requested. No interventions will be made on the infants with standard procedures followed for gentamicin initiation and ordering of levels. All study data will be de-identified. Thus, minimal to no risks are present outside of standard care of infants with personal information safeguarded.

Conditions

• Early Onset Sepsis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: Canada