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

Dalia Mohamed Salah50 enrolled

Overview

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

Randomised controlled trial

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Ventilator Associated Pneumonia

Interventions

Lactoferrin in prevention of VAPDIETARY_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.

ControlOTHER

They will receive standard preventive VAP strategies only.

Eligibility

Sex: ALLMin age: 0 DaysMax age: 90 Days

Medical Language ↔ Plain English

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.

Locations (1)

Neonatal Intensive Care Unit, Tanta University Children's Hospital

Tanta, Egypt

Outcomes

Primary Outcomes

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.

Prevention of VAP

Incidence of ventilator-associated pneumonia during mechanical ventilation.

Time frame: during NICU stay

Data from ClinicalTrials.gov

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