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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07001163

Enrollment

Registered

2025-06-03

Start date

2023-05-01

Completion date

2024-06-01

Last updated

2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Acquired Pneumonia

Keywords

VAP, NICU

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.

Interventions

DIETARY_SUPPLEMENTProbiotic

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Days to 28 Days

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026