Role of Lactoferrin in Prevention of Ventilator Associated Pneumonia in Neonates.

January 29, 2026 updated by: Dalia Mohamed Salah

The aim of the study is to

  1. Evaluate the preventive value of Lactoferrin on VAP among ventilated neonates.

  2. Evaluate the Primary outcome of Lactoferrin on:

    Sepsis, Feeding intolerance, Vomiting, Constipation or diarrhea

  3. Evaluate the effect of Lactoferrin in critically ventilated neonates on:

Incidence of VAP Duration of mechanical ventilation Duration of hospital stay

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomised controlled trial

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lactoferrin group
Neonates who will receive oral lactoferrin supplementation.
Dietary supplement: Lactoferrin in prevention of VAP
oral dose separate from feeds [at a daily dose of 100mg/day] via orogastric tube from first day of enrollment till time of successful extubation plus standard preventive measures of VAP; these include semi recumbent position, hand washing, suctioning when needed, endotracheal tube with subglottic secretion drainage, using heat and moisture exchanger filter, oral hygiene, changing of tubes only when needed and changing of ventilator circuit every 5 days.
Other: Control
who Will not receive
Other: Control
They will receive standard preventive VAP strategies only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevention of VAP
Time Frame: From enrollment until day 28 of life or NICU discharge, whichever occurs first.
Diagnosis of VAP using the CDC/NHSN clinical and radiological criteria for neonatal ventilator-associated events. Outcome measured as the percentage (%) of enrolled neonates who develop VAP during NICU stay or up to 28 days of life.
From enrollment until day 28 of life or NICU discharge, whichever occurs first.
Prevention of VAP
Time Frame: during NICU stay
Incidence of ventilator-associated pneumonia during mechanical ventilation.
during NICU stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalia Mohamed Salah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Actual)

December 1, 2025

Study Completion (Actual)

December 4, 2025

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264PR702/5/24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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