Role of Lactoferrin in Prevention of Ventilator Associated Pneumonia in Neonates.
NCT ID: NCT07255742
Last Updated: 2026-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2025-08-01
2025-12-04
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Lactoferrin group
Neonates who will receive oral lactoferrin supplementation.
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.
Control
who Will not receive
Control
They will receive standard preventive VAP strategies only.
Interventions
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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.
Control
They will receive standard preventive VAP strategies only.
Eligibility Criteria
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Inclusion Criteria
Gestational age: (GA 28-36 weeks).
Expected need for mechanical ventilation for ≥ (48hours)
Exclusion Criteria
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.
0 Days
90 Days
ALL
No
Sponsors
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Dalia Mohamed Salah
OTHER
Responsible Party
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Dalia Mohamed Salah
Lecturer
Locations
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Neonatal Intensive Care Unit, Tanta University Children's Hospital
Tanta, , Egypt
Countries
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Other Identifiers
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36264PR702/5/24
Identifier Type: -
Identifier Source: org_study_id
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