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Can breast milk or mouthwash stop pneumonia in preterm infants?

NCT ID NCT07482007

Prevention Sponsor: Tanta University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested four different mouth care methods—colostrum (early breast milk), chlorhexidine (an antiseptic), sodium bicarbonate (baking soda), and normal saline (salt water)—in 80 premature babies on breathing machines. The goal was to see which best prevents ventilator-associated pneumonia, a common and dangerous infection. Researchers tracked how many babies got pneumonia, how long they needed the ventilator, and how long they stayed in the hospital.

What this could mean

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

Active substance
colostrum, chlorhexidine, sodium bicarbonate, or normal saline (oral care solutions)
What this could lead to
If one of these oral care methods works best, it could help prevent a serious lung infection in premature babies on breathing machines, potentially saving lives and reducing hospital stays.
What could go wrong
This is a small, single-center study with only 80 babies, so results may not apply to all NICUs. The study is completed but not yet published, so we don't know if any method was clearly better or if there were side effects.

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

80 people

The number who actually took part.

Started

Apr 2024

Finished

Mar 2026

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Preterm neonates with gestational age less than 37 weeks. Neonates admitted to the Neonatal Intensive Care Unit (NICU). Neonates requiring invasive mechanical ventilation for more than 48 hours. Age ≤ 72 hours at time of enrollment. Written informed consent obtained from parents or legal guardians. Exclusion Criteria: * Neonates with major congenital anomalies. Neonates with congenital airway malformations. Presence of congenital pneumonia at birth. Neonates with severe gastrointestinal malformations preventing enteral feeding. Neonates who develop early-onset sepsis at admission. Neonates with contraindications to oral care procedures.

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Conditions

The condition(s) this trial relates to.

Pneumonia, Ventilator-Associated

As listed by the trial registrant

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

Ventilator associated pneumonia

Contacts and locations

Locations

  • Neonatal Intensive Care Unit, Tanta University Children's Hospital

    Tanta, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.