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

Lamiaa Khaled Zidan

Status: Completed

Conditions: Ventilator Acquired Pneumonia

Treatments: Dietary Supplement: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT07001163

Probiotics in neonatal VAP

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Probiotic group

Active Comparator group

Description:

40 ventilated neonates who received commercially available probiotics

Treatment:

Dietary Supplement: Probiotic

Non-probiotic group

No Intervention group

Description:

40 ventilated neonates who only received the standard of care treatment