Early Onset SepsisNCT07460349
Extended Interval Dosing of Gentamicin in Neonates
An observational study of Early Onset Sepsis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 7 days
- Conditions the study is for
- Early Onset Sepsis
- How many people
- 42 participants
- Where
- 1 siteCanada
- Study dates
- 17 Jun 2026to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 7 days
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Children's Hospital: London Health Sciences Centre
London, Ontario, N6A 5W9
Venita Harris, BScPharm, PharmD, 519-685-8500 ext. 52642, venita.harris@lhsc.on.ca
About this study
Official title: Extended Interval Dosing of Gentamicin in Neonates to Achieve Target Drug Concentrations
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.
Read the detailed description
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.
- Conditions
- Early Onset Sepsis
- Being tested
- 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
- Keywords
- gentamicin, extended interval dosing, neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care administration of gentamicin dosed at 3 mg/kg every 24 hoursOther
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.
Standard of care administration of gentamicin dosed at 3.5 mg/kg every 24 hoursOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Neonates less than 35 weeks gestational age | Not described Receives: Other: Standard of care administration of gentamicin dosed at 3 mg/kg every 24 hours | |
| Neonates at least 35 weeks gestational age | Not described Receives: Other: Standard of care administration of gentamicin dosed at 3.5 mg/kg every 24 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 3 of treatment: prior to the third gentamicin dose
Secondary outcomes (3)
Peak gentamicin levels
Maintain peak gentamicin levels within target range (6-10 mg/L)
Measured: Day 3 of treatment: following the third gentamicin dose
Incidence of suspected nephrotoxicity
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)
Measured: Seven days after discontinuation of gentamicin
Incidence of suspected ototoxicity
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
Measured: Up to 7 days following gentamicin discontinuation while infant is still admitted in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start17 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Early Onset SepsisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Venita Harris, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Venita Harris, PharmD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460349
- Sponsor's protocol ID
- 128253
- Status last verified
- Jun 2026
- First submitted
- 26 Feb 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 26836810Konig 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.
PubMed 25388408The 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.
PubMed 26986995Fullas 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.
PubMed 21164066Rao 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.
PubMed 27921299LexiDrug (Pediatric & Neonatal Lexi-Drugs) [Internet]. c2025 [cited 2025 November 24]. Gentamicin (Systemic).
LexiDrug [Internet]. c2025 [cited 2025 November 24]. Gentamicin (Systemic).
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.
PubMed 13679531Hodiamont 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.
PubMed 35754071Yun A. Extended Interval Dosing of Gentamicin in Neonates. Pharmacy Residency Manuscript 2005-2006.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extended Interval Dosing of Gentamicin in Neonates to Achieve Target Drug Concentrations
- ClinicalTrials.gov ID
- NCT07460349
- Acronym / sponsor ID
- 128253
- Conditions
- Early Onset Sepsis
- Keywords
- gentamicin, extended interval dosing, neonates
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 0 to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of care administration of gentamicin dosed at 3 mg/kg every 24 hoursNo 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. | Other | Neonates less than 35 weeks gestational age |
| Standard of care administration of gentamicin dosed at 3.5 mg/kg every 24 hoursNo 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. | Other | Neonates at least 35 weeks gestational age |
Primary outcome
Trough gentamicin levels
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.
3 secondary outcomes
Peak gentamicin levels
Time frame: Day 3 of treatment: following the third gentamicin dose
Incidence of suspected nephrotoxicity
Time frame: Seven days after discontinuation of gentamicin
Incidence of suspected ototoxicity
Time frame: Up to 7 days following gentamicin discontinuation while infant is still admitted in hospital
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- BackgroundCore Lab [Phone correspondence]. London; 2025 October 10. Analytical range of gentamicin concentrations.
- Background: PubMed 26836810van 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.
- Background: PubMed 25388408Konig 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.
- BackgroundThe Hospital for Sick Children Electronic Formulary [Internet]. c2025 [cited 2025 November 24]. Gentamicin.
- Background: PubMed 26986995El-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.
- Background: PubMed 21164066Fullas 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.
- Background: PubMed 27921299Rao 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.
- BackgroundLexiDrug (Pediatric & Neonatal Lexi-Drugs) [Internet]. c2025 [cited 2025 November 24]. Gentamicin (Systemic).
- BackgroundLexiDrug [Internet]. c2025 [cited 2025 November 24]. Gentamicin (Systemic).
- Background: PubMed 13679531Kearns 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.
- Background: PubMed 35754071Hodiamont 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.
- Results publicationYun A. Extended Interval Dosing of Gentamicin in Neonates. Pharmacy Residency Manuscript 2005-2006.
- Stanford Health Care Aminoglycoside Dosing GuidelineLink provided by the sponsor.
- CHEO Outreach - GentamicinLink provided by the sponsor.
- Children's Hospital London Health Sciences Centre - Neonatal Intensive Care Unit - GentamicinLink provided by the sponsor.
- London Health Sciences Centre Pathology and Laboratory Medicine - GentamicinLink provided by the sponsor.
- PROTOCOL FOR UNIVERSAL NEWBORN HEARING SCREENING IN ONTARIOLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Venita Harris, PharmD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Onset Sepsis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah H.P. Vo, PharmD (519-685-8500 ext. 52162, sarah.vo@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trough gentamicin levels (time frame: Day 3 of treatment: prior to the third gentamicin dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07460349, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.