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Could simple mouth care prevent lung infections in preemies?

NCT ID NCT05167318

Disease control Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 cleaning the mouth of very premature infants every 3-4 hours can reduce harmful bacteria and lower the risk of pneumonia and other breathing problems. Researchers will follow 40 infants born before 32 weeks and weighing less than 1500 grams, comparing two different schedules of oral care. The goal is to see if more frequent care is feasible and improves health outcomes.

What this could mean

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

Active substance
standardized oral care
What this could lead to
If it works, this could lead to a simple, low-cost way to reduce pneumonia and chronic lung disease in premature infants.
What could go wrong
This is a small, early feasibility study with only 40 infants, so results may not be conclusive or apply to all 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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

150 people

The number who actually took part.

Started

Jan 2022

Expected to finish

Oct 2026

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

12 to 72 hours

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: * Gestational age \< 32 weeks * birth weight \< 1500 grams * mother is English speaking * mother is \> 18 years of age. Exclusion Criteria: * Congenital anomalies of the face, lungs, or gastrointestinal system * not expected to survive

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Conditions

The condition(s) this trial relates to.

infectious disease Pneumonia, Ventilator-Associated

As listed by the trial registrant

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

Microbial colonization Ventilator associated pneumonia

Contacts and locations

Locations

  • University of Florida

    Gainesville, Florida, 32610, United States

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