Children's Hospital: London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Location status: Recruiting
NCT Number: NCT07460349
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.
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All sexes
Observational
London, Ontario, N6A 5W9, Canada
Location status: Recruiting
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. If the infant meets the study inclusion criteria, a letter of information will be provided to the parent(s)/guardian(s) if agreeable using REDCap. Consent must be obtained prior to enrollment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Day 3 of treatment: prior to the third gentamicin dose
The primary objective is to measure and monitor the 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.
Time frame: Day 3 of treatment: following the third gentamicin dose
Maintain peak gentamicin levels within target range (6-10 mg/L)
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)
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
Contact information is provided by the study sponsor or research team.
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Other
Extended Interval Dosing of Gentamicin in Neonates to Achieve Target Drug Concentrations
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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