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

NCT07255742 | Completed DMC

• 1 other identifier: 36264PR702/5/24
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to

1. 1.Evaluate the preventive value of Lactoferrin on VAP among ventilated neonates.
2. 2.Evaluate the Primary outcome of Lactoferrin on:
3. 3.Evaluate the effect of Lactoferrin in critically ventilated neonates on:

Conditions

Ventilator Associated Pneumonia

Keywords

Lactoferrin,VAP

Outcome Measures

Primary Outcomes (2)

• 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.

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

• Prevention of VAP

  Incidence of ventilator-associated pneumonia during mechanical ventilation.

  during NICU stay

Study Arms (2)

Lactoferrin group

EXPERIMENTAL

Neonates who will receive oral lactoferrin supplementation.

Dietary Supplement: Lactoferrin in prevention of VAP

Control

OTHER

who Will not receive

Other: Control

Interventions

Lactoferrin in prevention of VAP DIETARY_SUPPLEMENT

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.

Lactoferrin group

Control OTHER

They will receive standard preventive VAP strategies only.

Control

Eligibility Criteria

• Age: 0 Days - 90 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonates requiring mechanical ventilation.
• Gestational age: (GA 28-36 weeks).
• Expected need for mechanical ventilation for ≥ (48hours)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dalia Mohamed Salah: lead

Study Sites (1)

Neonatal Intensive Care Unit, Tanta University Children's Hospital

Tanta, Egypt

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Lactoferrin

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Glycoproteins; Glycoconjugates; Carbohydrates; Transferrins; Iron-Binding Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Lactoglobulins; Whey Proteins; Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Globulins; Metalloproteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 1, 2025
• Study Start: August 1, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 4, 2025
• Last Updated: February 2, 2026

Record last verified: 2025-11

Locations

EG (1)