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RecruitingNCT07255742Updated Oct 6, 2026

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

An interventional study of Lactoferrin in prevention of VAP and Control in Ventilator Associated Pneumonia, sponsored by Dalia Mohamed Salah. Recruiting at 1 site in Egypt. Open to participants aged 0 Days to 90 Days. Per ClinicalTrials.gov, last updated 2026-10-06.

Sponsored by Dalia Mohamed Salah · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Aug 2025, registered Nov 2025).
  • Started Aug 2025; still recruiting 1 year 2 months later.
Updated Oct 6, 2026Now RecruitingSite recruiting status changed+4 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
0 Days to 90 Days
Sex
All
01

Study summary

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

Read the detailed description

Randomised controlled trial

02

Conditions studied

  • Ventilator Associated Pneumonia

Keywords

  • Lactoferrin,VAP
03

In context

Pneumonia, Ventilator-Associated

392 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 81 are open to participants now.

This study's planned enrollment of 120 is close to the median of 122 across 254 interventional studies indexed under Pneumonia, Ventilator-Associated.

Browse Pneumonia, Ventilator-Associated studies →

Lead sponsor

This is the only study on the registry with Dalia Mohamed Salah as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Days to 90 Days
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

neonates requiring mechanical ventilation.

Gestational age:

Expected need for mechanical ventilation for ≥ (48hours)

Exclusion criteria

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.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Lactoferrin group

    Neonates who will receive oral lactoferrin supplementation.

    Dietary Supplement: Lactoferrin in prevention of VAP

  • Other
    Control

    who Will not receive

    Other: Control

Interventions

  • Dietary supplementLactoferrin 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.

  • OtherControl

    They will receive standard preventive VAP strategies only.

06

What researchers measure

Primary outcomes

  1. Prevention of VAP

    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.

    Time frame: From enrollment until day 28 of life or NICU discharge, whichever occurs first.

  2. Prevention of VAP

    Incidence of ventilator-associated pneumonia during mechanical ventilation.

    Time frame: during NICU stay

07

Study locations

1 of 1 sites recruiting
  • Neonatal Intensive Care Unit, Tanta University Children's Hospital
    Tanta, Egypt
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Status
Completed→Recruiting
changed Oct 6, 2026
Sites
Neonatal Intensive Care Unit, Tanta University Children's Hospital is now Recruiting
Oct 6, 2026
Primary completion
Dec 1, 2025→Nov 1, 2026
Oct 6, 2026
Study completion
Dec 4, 2025→Nov 1, 2026
Oct 6, 2026
Enrollment
50 (actual)→120 (estimated)
Oct 6, 2026
Also revised
eligibility
Show all 1 update
  1. Oct 6, 2026
    Completed→Recruiting
    Neonatal Intensive Care Unit, Tanta University Children's Hospital is now Recruiting
    Primary completion Dec 1, 2025→Nov 1, 2026
    Study completion Dec 4, 2025→Nov 1, 2026
    Enrollment 50 (actual)→120 (estimated)
    Eligibility Criteria revised
    + 1 other change: contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07255742
Lead sponsor
Dalia Mohamed Salah
Responsible party
Dalia Mohamed Salah (Lecturer, Tanta University) — Sponsor-investigator
First posted
Dec 1, 2025
Start date
Aug 1, 2025
Primary completion
Nov 1, 2026 (estimated)
Completion
Nov 1, 2026 (estimated)
Last update
Oct 6, 2026

Study contacts

Dalia Ayoub
Contact
dalia.ayoub@med.tanta.edu.eg
+201066343989

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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