Administração de Gentamicina em Intervalos Prolongados em Neonatos
Dosagem em Intervalo Alargado de Gentamicina em Recém-nascidos para Alcançar Concentrações Alvo do Fármaco
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.
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Contactos e Locais
Contato de estudo
- Nome: Sarah H.P. Vo, PharmD
- Número de telefone: 52162 519-685-8500
- E-mail: sarah.vo@lhsc.on.ca
Locais de estudo
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Ontario
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London, Ontario, Canadá, N6A 5W9
- Recrutamento
- Children's Hospital: London Health Sciences Centre
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Contato:
- Venita Harris, BScPharm, PharmD
- Número de telefone: 52642 519-685-8500
- E-mail: venita.harris@lhsc.on.ca
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
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
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: COHORT
- Perspectivas de Tempo: PROSPECTIVE
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Neonatos com menos de 35 semanas de idade gestacional
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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. |
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Recém-nascidos com pelo menos 35 semanas de idade gestacional
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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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Trough gentamicin levels
Prazo: Day 3 of treatment: prior to the third gentamicin dose
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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. |
Day 3 of treatment: prior to the third gentamicin dose
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Peak gentamicin levels
Prazo: 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
Prazo: Seven days after discontinuation of gentamicin
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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
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|
Incidence of suspected ototoxicity
Prazo: Up to 7 days following gentamicin discontinuation while infant is still admitted in hospital
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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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Venita Harris, PharmD, London Health Sciences Centre
Publicações e links úteis
Publicações Gerais
- Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE. Developmental pharmacology--drug disposition, action, and therapy in infants and children. N Engl J Med. 2003 Sep 18;349(12):1157-67. doi: 10.1056/NEJMra035092. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
- LexiDrug (Pediatric & Neonatal Lexi-Drugs) [Internet]. c2025 [cited 2025 November 24]. Gentamicin (Systemic).
- LexiDrug [Internet]. c2025 [cited 2025 November 24]. Gentamicin (Systemic).
- Hodiamont CJ, van den Broek AK, de Vroom SL, Prins JM, Mathot RAA, van Hest RM. Clinical Pharmacokinetics of Gentamicin in Various Patient Populations and Consequences for Optimal Dosing for Gram-Negative Infections: An Updated Review. Clin Pharmacokinet. 2022 Aug;61(8):1075-1094. doi: 10.1007/s40262-022-01143-0. Epub 2022 Jun 27.
- Yun A. Extended Interval Dosing of Gentamicin in Neonates. Pharmacy Residency Manuscript 2005-2006.
Links úteis
- <p>Stanford Health Care Aminoglycoside Dosing Guideline</p>
- <p>CHEO Outreach - Gentamicin</p>
- <p>Children's Hospital London Health Sciences Centre - Neonatal Intensive Care Unit - Gentamicin</p>
- <p>London Health Sciences Centre Pathology and Laboratory Medicine - Gentamicin</p>
- <p>PROTOCOL FOR UNIVERSAL NEWBORN HEARING SCREENING IN ONTARIO</p>
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Outros números de identificação do estudo
- 128253
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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.
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