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Breast milk mouth care may help preterm infants breathe easier

NCT ID NCT07451964

Disease control Sponsor: Ain Shams 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether giving oral care with maternal breast milk every 3 hours to preterm babies on breathing machines could improve outcomes. 70 infants born before 34 weeks were included. Researchers measured how long babies needed ventilation, hospital stay length, and rates of infections like pneumonia and sepsis.

What this could mean

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

Active substance
maternal breast milk
What this could lead to
If it works, this simple oral care routine could shorten time on breathing machines and lower infection risk for preterm babies.
What could go wrong
This is a small, completed study with 70 infants, so results may not apply broadly. The intervention is not a treatment for the underlying lung condition.

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

70 people

The number who actually took part.

Started

Jun 2025

Finished

Nov 2025

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 hours to 3 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: 1. Gestational age less than 34 weeks 2. Patients with moderate to severe respiratory distress syndrome on invasive mechanical ventilation in the 1st 3 days of life 3. Available maternal breast milk 4. Patients delivered by caesarean section Exclusion Criteria: 1. Patients with no available maternal breast milk 2. Preterms who had a surgical procedure 3. Patients with inborn error of metabolism 4. Patients with major congenital anomalies 5. Patients with hypoxic ischemic enceohalopathy 6. Patients delivered by vaginal delivery

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Conditions

The condition(s) this trial relates to.

respiratory distress syndrome in premature infants

As listed by the trial registrant

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

Role of oral care in mechanically ventilated preterm infants

Contacts and locations

Locations

  • Faculty of medicine Ain shams university

    Cairo, Egypt

More trials for these conditions

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