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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07255742

Enrollment

Registered

2025-12-01

Start date

2025-08-01

Completion date

2025-12-04

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia

Keywords

Lactoferrin,VAP

Brief summary

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

Detailed description

Randomised controlled trial

Interventions

DIETARY_SUPPLEMENTLactoferrin 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.

OTHERControl

They will receive standard preventive VAP strategies only.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Days to 90 Days

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.

Design outcomes

Primary

Measure	Time frame	Description
Prevention of VAP	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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026