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Milk protein may shield preemie lungs from ventilator infection

NCT ID NCT07255742

Prevention Sponsor: Dalia Mohamed Salah 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether giving lactoferrin, a protein found in milk, to preterm babies on breathing machines could prevent ventilator-associated pneumonia (VAP). Fifty premature newborns received either lactoferrin plus standard care or standard care alone. The goal was to see if the supplement reduced infections, shortened time on the ventilator, and cut hospital stays.

What this could mean

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

Active substance
lactoferrin (a dietary supplement)
What this could lead to
If it works, this could point toward a simple, low-cost way to prevent a serious lung infection in premature babies on ventilators.
What could go wrong
This is a small, completed trial with only 50 babies, so results may not apply to all newborns. Lactoferrin might not reduce pneumonia risk and could cause digestive issues like vomiting or diarrhea.

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

50 people

The number who actually took part.

Started

Aug 2025

Finished

Dec 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 to 90 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: Preterm neonates requiring mechanical ventilation. Gestational age: (GA 28-36 weeks). Expected need for mechanical ventilation for ≥ (48hours) Exclusion Criteria: Congenital anomalies of the lung or airway. Major congenital heart disease. Proven early-onset sepsis at enrollment. Severe perinatal asphyxia (e.g., Apgar \< 3 at 5 minutes or seizures). Known contraindication or allergy to lactoferrin. Severe gastrointestinal pathology (e.g., NEC stage II or higher). Any condition deemed by the clinical team to interfere with study participation.

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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.