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Completed

NCT Number: NCT07001163

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

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

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Key information

Conditions

Ventilator Acquired Pneumonia Cross Infection Disease Attributes Healthcare-Associated Pneumonia Iatrogenic Disease Infections Lung Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Tanta University

Tanta, Q2x2+cp Tanta 2, Egypt,, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary Supplement

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

Primary outcomes

  1. 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

  1. GIT manifestations

    Time frame: 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.

  2. Duration of MV and NICU stay

    Time frame: one year

    Assessment of the impact of probiotic supplementation on critically ventilated neonates in terms of mechanical ventilation duration and NICU length of stay.

Sponsors and collaborators

Lead sponsor

Lamiaa Khaled Zidan

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 3, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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