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

Not Applicable

Completed

• Conditions: Ventilator Acquired Pneumonia

• Registration Number: NCT07001163
• Lead Sponsor: Lamiaa Khaled Zidan

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 Timeline

• Study Start: 2023-05-01
• Primary Completion: 2024-05-01
• Study Completion: 2024-06-01
• Status Verified: 2025-05
• Study First Submitted: 2025-05-23
• Study First Submitted QC: 2025-05-23
• Last Update Submitted: 2025-05-23
• Study First Posted: 2025-06-03
• Last Update Posted: 2025-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
VAP incidence rate	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 Outcome Measures

Name	Time	Method
GIT manifestations	one year	Evaluation of the effect of probiotics in critically ventilated neonates on the incidence of GIT manifestations as Feeding intolerance, Vomiting, Constipation, or diarrhea.
Duration of MV and NICU stay	one year	Assessment of the impact of probiotic supplementation on critically ventilated neonates in terms of mechanical ventilation duration and NICU length of stay.

Trial Locations

Locations (1)

Faculty of Medicine, Tanta University; 🇪🇬 Tanta, Q2x2+cp Tanta 2, Egypt,, Egypt