Extended Interval Dosing of Gentamicin in Neonates

March 3, 2026 updated by: Venita Harris, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Children's Hospital: London Health Sciences Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Neonates admitted to the Neonatal Intensive Care Unit, Paediatric Critical Care Unit (PCCU), or Paediatrics Unit (B6) at the Children's Hospital, London Health Sciences Centre

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Neonates less than 35 weeks gestational age
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.
Neonates at least 35 weeks gestational age
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trough gentamicin levels
Time Frame: Day 3 of treatment: prior to the third gentamicin dose
The primary objective is to achieve a greater number of trough gentamicin levels within target range < 2 mg/L with the current extended interval dosing regimen compared to traditional dosing in neonates ≤ 7 days of age.
Day 3 of treatment: prior to the third gentamicin dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak gentamicin levels
Time Frame: Day 3 of treatment: following the third gentamicin dose
Maintain peak gentamicin levels within target range (6-10 mg/L)
Day 3 of treatment: following the third gentamicin dose
Incidence of suspected nephrotoxicity
Time Frame: Seven days after discontinuation of gentamicin
Monitor the incidence of suspected nephrotoxicity (serum creatinine > 53 umol/L, Blood Urea Nitrogen (BUN) > 10 mmol/L, and urine output < 1 mL/kg/h)
Seven days after discontinuation of gentamicin
Incidence of suspected ototoxicity
Time Frame: Up to 7 days following gentamicin discontinuation while infant is still admitted in hospital
Monitor the incidence of suspected ototoxicity (failed on newborn hearing screening) in different dosing regimens. Newborn hearing screening tests follow electrophysiological methods with automated distortion product otoacoustic emissions and automated auditory brainstem response
Up to 7 days following gentamicin discontinuation while infant is still admitted in hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Investigators

  • Principal Investigator: Venita Harris, PharmD, London Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

February 26, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 10, 2026

Study Record Updates

Last Update Posted (Actual)

March 10, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 128253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a small scale cohort study that is less likely to be useful for a wider population. Our ethics submission did not include a plan to share the study database.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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