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Could preterm babies safely get fewer antibiotics?

NCT ID NCT07610486

Knowledge-focused Sponsor: Duke University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 06, 2026 · Updated 6 times

Summary

This study looks at whether preterm infants in the NICU can safely stop taking the antibiotic ampicillin after 24 to 36 hours instead of the usual 48 hours. Researchers will measure drug levels in the blood and monitor the babies for any problems. The goal is to see if a shorter course still provides enough protection against infection while reducing unnecessary medication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ampicillin
What this could lead to
If successful, this could show that a shorter course of antibiotics is safe and effective for preterm infants, potentially reducing unnecessary antibiotic exposure.
What could go wrong
This is an early-phase trial with only 60 infants, so results may not apply to all preterm babies. There is a risk that shorter treatment might not prevent infection.

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.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 60 people

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

Started

Jul 2026

Expected to finish

Dec 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.

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: * Documented informed consent from parent/guardian * Infants admitted to the Duke Neonatal Intensive Care Unit (NICU) * less than or equal to 34 completed weeks gestational age (GA) at birth and \< 7 days of life at time of screening * Prescribed ampicillin by provider per standard of care for evaluation of early onset sepsis Exclusion Criteria: * Infant on extracorporeal support (e.g., ECMO) * Positive blood culture or other confirmed infection * At time of consent, infants with GA \<28 completed weeks who have received more than 24 hours of empiric ampicillin OR infants with GA 28 to 34 completed weeks who have received \> 32 to 36 hours of ampicillin, depending on dosing regimen * Has major congenital abnormalities where survival to 30 days of life is not expected * Receives a course of ampicillin that is longer (i.e., more doses) than the short-course defined regimen for their GA * Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

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Conditions

The condition(s) this trial relates to.

neonatal sepsis

As listed by the trial registrant

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

Ampicillin Early onset sepsis NICU Preterm neonates Safety and pharmacokinetics

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

  • Duke Health Neonatal Intensive Care Unit

    RECRUITING

    Durham, North Carolina, 27705, United States

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