Forlenget intervall-dosering av Gentamicin hos nyfødte
Utvidet intervall-dosering av Gentamicin hos nyfødte for å oppnå målmedikamentkonsentrasjoner
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Sarah H.P. Vo, PharmD
- Telefonnummer: 52162 519-685-8500
- E-post: sarah.vo@lhsc.on.ca
Studiesteder
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Ontario
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London, Ontario, Canada, N6A 5W9
- Rekruttering
- Children's Hospital: London Health Sciences Centre
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Ta kontakt med:
- Venita Harris, BScPharm, PharmD
- Telefonnummer: 52642 519-685-8500
- E-post: venita.harris@lhsc.on.ca
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Nyfødte med gestasjonsalder under 35 uker
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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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Nyfødte med minst 35 uker svangerskapsalder
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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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Trough gentamicin levels
Tidsramme: 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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Peak gentamicin levels
Tidsramme: Day 3 of treatment: following the third gentamicin dose
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Maintain peak gentamicin levels within target range (6-10 mg/L) |
Day 3 of treatment: following the third gentamicin dose
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Incidence of suspected nephrotoxicity
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Venita Harris, PharmD, London Health Sciences Centre
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Hjelpsomme linker
- <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>
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 128253
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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