Assessment of the Role of Probiotics in Prevention of Ventilator-Associated Pneumonia in Neonates
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- VAP incidence rate
Study Overview
Brief Summary
Evaluate the preventive value of probiotics on VAP among ventilated neonates.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 1 Day to 28 Days (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All term neonates who required mechanical ventilation with ETT for more than 48 hours.
Exclusion Criteria
- •Early-onset neonatal sepsis
- •Pre-existing pneumonia
- •A patient who was unfit for enteral intake.
- •Prematurity <37 gestational weeks.
- •Surgical causes of mechanical ventilation
- •Multiple congenital anomalies and suspected chromosomal anomalies.
Arms & Interventions
Non-probiotic group
40 ventilated neonates who only received the standard of care treatment
Probiotic group
40 ventilated neonates who received commercially available probiotics
Intervention: Probiotic (Dietary Supplement)
Outcomes
Primary Outcomes
VAP incidence rate
Time Frame: one year
Evaluation of the role of probiotics in the Prevention of neonatal VAP and examining their impact on the incidence of VAP at those neonates.
Secondary Outcomes
- GIT manifestations(one year)
- Duration of MV and NICU stay(one year)
Investigators
Lamiaa Khaled Zidan
Lecturer
Tanta University