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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-06-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Ventilator Acquired Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Probiotic group

40 ventilated neonates who received commercially available probiotics

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DIETARY_SUPPLEMENT

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

Non-probiotic group

40 ventilated neonates who only received the standard of care treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Probiotic

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

1 Day

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No