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New study aims to perfect antibiotic dosing for newborns

NCT ID NCT07460349

Disease control Sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether the current dosing of the antibiotic gentamicin is safe and effective for newborns up to 7 days old who have early-onset sepsis. Researchers will measure drug levels in the blood and check for kidney or hearing problems. The goal is to confirm that giving the dose less often works best and to create a standard guideline for hospitals.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

0 to 7 days

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early onset sepsis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Children's Hospital: London Health Sciences Centre

    RECRUITING

    London, Ontario, N6A 5W9, Canada

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