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Milk protein shows promise in preventing deadly infections in preemies

NCT ID NCT07480434

Prevention Sponsor: Zartash Sial Paeds Med 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving a protein called lactoferrin (found in milk) to premature babies could help prevent sepsis, a severe infection. The trial included 180 preterm infants with low birth weight, who received lactoferrin or a placebo within 72 hours of birth. The goal was to see if this simple supplement could reduce the risk of sepsis in this vulnerable group.

What this could mean

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

Active substance
bovine lactoferrin (a protein from cow's milk)
What this could lead to
If it works, this could point toward a simple, safe way to reduce life-threatening infections in premature babies.
What could go wrong
This was a small, early-phase study (Phase 1) with only 180 participants. Results may not be conclusive, and larger trials are needed to confirm any benefit.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

180 people

The number who actually took part.

Started

Oct 2024

Finished

Mar 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

Up to 37 weeks

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 (Neonates who are born before the completion of 37 weeks of pregnancy) * Low birth weight infants less than 2500 grams at birth * Recruited within the first 72 hours after birth * Admitted to the Neonatology department Exclusion Criteria: * Neonates born with congenital anomalies * Newborns with infections identified at the time of birth, signs of infection on admission (fever, respiratory problems, etc.), or infection detected by the physician.

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Conditions

The condition(s) this trial relates to.

Sepsis infectious disease with sepsis prevention target

As listed by the trial registrant

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

Sepsis

Contacts and locations

Locations

  • King Edward Medical University Lahore

    Lahore, Punjab Province, 54000, Pakistan

More trials for these conditions

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