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

NCT ID: NCT07255742

Last Updated: 2026-02-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-12-04

Brief Summary

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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

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Randomised controlled trial

Conditions

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Ventilator Associated Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lactoferrin group

Neonates who will receive oral lactoferrin supplementation.

Group Type EXPERIMENTAL

Lactoferrin in prevention of VAP

Intervention Type 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

who Will not receive

Group Type OTHER

Control

Intervention Type OTHER

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.

Intervention Type DIETARY_SUPPLEMENT

Control

They will receive standard preventive VAP strategies only.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

0 Days

Maximum Eligible Age

90 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dalia Mohamed Salah

OTHER

Sponsor Role lead

Responsible Party

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Dalia Mohamed Salah

Lecturer

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Neonatal Intensive Care Unit, Tanta University Children's Hospital

Tanta, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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36264PR702/5/24

Identifier Type: -

Identifier Source: org_study_id

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