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OpenTrials
Completed

NCT Number: NCT07255742

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

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

Completed

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Key information

Conditions

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

Age range

0 day–90 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Neonatal Intensive Care Unit, Tanta University Children's Hospital

Tanta, Egypt

About this study

Randomised controlled trial

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Control

Other

They will receive standard preventive VAP strategies only.

Primary outcomes

  1. 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.

  2. Prevention of VAP

    Time frame: during NICU stay

    Incidence of ventilator-associated pneumonia during mechanical ventilation.

Sponsors and collaborators

Lead sponsor

Dalia Mohamed Salah

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 1, 2025
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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