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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Dalia Mohamed Salah • ClinicalTrials.gov ID: NCT07255742

Registry updated: 2026-10-06
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Description

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

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.
  • Control (Other)
    They will receive standard preventive VAP strategies only.

Eligibility criteria

Inclusion Criteria: neonates requiring mechanical ventilation. Gestational age: 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.

Conditions

Ventilator Associated Pneumonia

Locations

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

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record