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

ConditionVentilator Associated Pneumonia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age0-90

SponsorDalia Mohamed Salah

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

Lactoferrin in prevention of VAP
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
Other intervention
They will receive standard preventive VAP strategies only.

Treatment groups

120 Participants

are divided into 2 treatment groups

Group A: Lactoferrin groupExperimental treatment 1 intervention

Group B: ControlOther 1 intervention

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dalia Mohamed Salah

Lead sponsor

Tanta University

Sponsor institution

Source ClinicalTrials.gov

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