Assessment of the Role of Probiotics in Prevention of Ventilator-Associated Pneumonia in Neonates

Lamiaa Khaled Zidan80 enrolled

Overview

Evaluate the preventive value of probiotics on VAP among ventilated neonates.

MV is a critical component of neonatal intensive care, providing essential respiratory support for neonates with severe respiratory distress. However, its use is associated with an increased risk of VAP, a serious nosocomial lung infection. VAP is defined as a pneumonia diagnosed in patients undergoing MV for at least 48 hours and is recognized as the second most common nosocomial infection in neonatal and pediatric intensive care units. Its incidence ranges from 1 to 63 episodes per 1,000 ventilation days, with variability influenced by the socioeconomic and healthcare development of different regions.Given the complex pathophysiology of VAP, numerous prevention strategies have been proposed for NICUs.Among these strategies, probiotics have emerged.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Ventilator Acquired Pneumonia

Interventions

ProbioticDIETARY_SUPPLEMENT

Probiotic sachets contained 1× 109 colony-forming unit of Bifidobacterium Animalis subsp.lactis BB-12), were given via orogastric tube twice daily.

Eligibility

Sex: ALLMin age: 1 DayMax age: 28 Days

Medical Language ↔ Plain English

Inclusion Criteria: * All term neonates who required mechanical ventilation with ETT for more than 48 hours. Exclusion Criteria: 1. Early-onset neonatal sepsis 2. Pre-existing pneumonia 3. A patient who was unfit for enteral intake. 4. Prematurity \<37 gestational weeks. 5. Surgical causes of mechanical ventilation 6. Multiple congenital anomalies and suspected chromosomal anomalies.

Locations (1)

Faculty of Medicine, Tanta University

Tanta, Q2x2+cp Tanta 2, Egypt,, Egypt

Outcomes

Primary Outcomes

VAP incidence rate

Evaluation of the role of probiotics in the Prevention of neonatal VAP and examining their impact on the incidence of VAP at those neonates.

Time frame: one year

Secondary Outcomes

GIT manifestations

Evaluation of the effect of probiotics in critically ventilated neonates on the incidence of GIT manifestations as Feeding intolerance, Vomiting, Constipation, or diarrhea.

Time frame: one year

Duration of MV and NICU stay

Assessment of the impact of probiotic supplementation on critically ventilated neonates in terms of mechanical ventilation duration and NICU length of stay.

Time frame: one year

Data from ClinicalTrials.gov

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