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

Dalia Mohamed Salah

Status: Completed

Conditions: Ventilator Associated Pneumonia

Treatments: Dietary Supplement: Lactoferrin in prevention of VAP; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT07255742

36264PR702/5/24

Details and patient eligibility

About

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

Full description

Randomised controlled trial

Enrollment: 50 patients

Sex: All

Ages: Under 90 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Lactoferrin group

Experimental group

Description:

Neonates who will receive oral lactoferrin supplementation.

Treatment:

Dietary Supplement: Lactoferrin in prevention of VAP

Control

Other group

Description:

who Will not receive

Treatment:

Other: Control