Extended Interval Dosing of Gentamicin in Neonates

NCT07460349 | Recruiting

• 1 other identifier: 128253
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Early Onset Sepsis

Keywords

gentamicin; extended interval dosing; neonates

Outcome Measures

Primary Outcomes (1)

• Trough gentamicin levels

  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

Secondary Outcomes (3)

• Peak gentamicin levels

  Day 3 of treatment: following the third gentamicin dose

• Incidence of suspected nephrotoxicity

  Seven days after discontinuation of gentamicin

• Incidence of suspected ototoxicity

  Up to 7 days following gentamicin discontinuation while infant is still admitted in hospital

Study Arms (2)

Neonates less than 35 weeks gestational age

Other: Standard of care administration of gentamicin dosed at 3 mg/kg every 24 hours

Neonates at least 35 weeks gestational age

Other: Standard of care administration of gentamicin dosed at 3.5 mg/kg every 24 hours

Interventions

Standard of care administration of gentamicin dosed at 3 mg/kg every 24 hours OTHER

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 less than 35 weeks gestational age

Standard of care administration of gentamicin dosed at 3.5 mg/kg every 24 hours OTHER

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

Eligibility Criteria

• Age: 0 Days - 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Children's Hospital: London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

RECRUITING

Related Publications (12)

• Core Lab [Phone correspondence]. London; 2025 October 10. Analytical range of gentamicin concentrations.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• The Hospital for Sick Children Electronic Formulary [Internet]. c2025 [cited 2025 November 24]. Gentamicin.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• LexiDrug (Pediatric & Neonatal Lexi-Drugs) [Internet]. c2025 [cited 2025 November 24]. Gentamicin (Systemic).

  BACKGROUND

• LexiDrug [Internet]. c2025 [cited 2025 November 24]. Gentamicin (Systemic).

  BACKGROUND

• 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.

  PMID: 13679531 BACKGROUND

• 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.

  PMID: 35754071 BACKGROUND

• Yun A. Extended Interval Dosing of Gentamicin in Neonates. Pharmacy Residency Manuscript 2005-2006.

  RESULT

Related Links

• Stanford Health Care Aminoglycoside Dosing Guideline
• CHEO Outreach - Gentamicin
• Children's Hospital London Health Sciences Centre - Neonatal Intensive Care Unit - Gentamicin
• London Health Sciences Centre Pathology and Laboratory Medicine - Gentamicin
• PROTOCOL FOR UNIVERSAL NEWBORN HEARING SCREENING IN ONTARIO

Study Officials

• Venita Harris, PharmD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah H.P. Vo, PharmD

CONTACT

519-685-8500; sarah.vo@lhsc.on.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pharmacy Residency Specialist

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 10, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)