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Идёт набор NCT07460349

Extended Interval Dosing of Gentamicin in Neonates

— Наблюдательное Early Onset Sepsis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Standard of care administration of gentamicin dosed at 3 mg/kg every 24 hours, Standard of care administration of gentamicin dosed at 3.5 mg/kg every 24 hours.
Кому может быть актуально
Состояния в реестре: Early Onset Sepsis. Базовые параметры: 0 Days — 7 Days · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Другое 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.
  • Другое 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.

Первичные конечные точки

  • Trough gentamicin levels [Срок оценки: Day 3 of treatment: prior to the third gentamicin dose]
Вторичные конечные точки (3)
  • Peak gentamicin levels [Срок оценки: Day 3 of treatment: following the third gentamicin dose]
  • Incidence of suspected nephrotoxicity [Срок оценки: Seven days after discontinuation of gentamicin]
  • Incidence of suspected ototoxicity [Срок оценки: Up to 7 days following gentamicin discontinuation while infant is still admitted in hospital]

Критерии участия

Критерии включения

  • 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.

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • Children's Hospital: London Health Sciences Centre — London

Публикации

  • Core Lab [Phone correspondence]. London; 2025 October 10. Analytical range of gentamicin concentrations.
  • van Maarseveen EM, Sprij A, Touw DJ. Extended-Interval Dosing of Gentamicin Aiming for a Drug-Free Period in Neonates: A Prospective Cohort Study. Ther Drug Monit. 2016 Jun;38(3):402-6. doi: 10.1097/FTD.0000000000000283. PMID 26836810
  • Konig K, Lim A, Miller A, Saker S, Guy KJ, Barfield CP. Gentamicin trough levels using a simplified extended-interval dosing regimen in preterm and term newborns. Eur J Pediatr. 2015 May;174(5):669-73. doi: 10.1007/s00431-014-2450-z. Epub 2014 Nov 12. PMID 25388408
  • The Hospital for Sick Children Electronic Formulary [Internet]. c2025 [cited 2025 November 24]. Gentamicin.
  • El-Chaar GM, Supaswud-Franks T, Venugopalan L, Kohn N, Castro-Alcaraz S. Extended-interval gentamicin administration in neonates: a simplified approach. J Perinatol. 2016 Aug;36(8):660-5. doi: 10.1038/jp.2016.37. Epub 2016 Mar 17. PMID 26986995
  • Fullas F, Padomek MT, Thieman CJ, Van Gorp AE. Comparative evaluation of six extended-interval gentamicin dosing regimens in premature and full-term neonates. Am J Health Syst Pharm. 2011 Jan 1;68(1):52-6. doi: 10.2146/ajhp100114. PMID 21164066
  • Rao SC, Srinivasjois R, Moon K. One dose per day compared to multiple doses per day of gentamicin for treatment of suspected or proven sepsis in neonates. Cochrane Database Syst Rev. 2016 Dec 6;12(12):CD005091. doi: 10.1002/14651858.CD005091.pub4. PMID 27921299
  • LexiDrug (Pediatric & Neonatal Lexi-Drugs) [Internet]. c2025 [cited 2025 November 24]. Gentamicin (Systemic).

Идентификаторы

NCT: NCT07460349 · 128253

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗