Probiotic Role in Prevention of Ventilator Associated Pneumonia in Critically- Ill Children Admitted at Pediatric Intensive Care Unit

NCT07848165 | Recruiting

• 1 other identifier: 36264MS985/6/25
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the work is to evaluate the impact of Probiotics supplementation on prevention of ventilator associated pneumonia in critically ill children admitted at Pediatric Intensive Care Unit at Tanta University Hospitals.

Conditions

Probiotic; Ventilator Associated Pneumonia; Critically- Ill Children

Outcome Measures

Primary Outcomes (1)

• Incidence of ventilator-associated pneumonia

  Incidence of ventilator-associated pneumonia (VAP) diagnosed according to predefined CDC/NHSN pediatric criteria

  During the first 28 days after initiation of mechanical ventilation

Secondary Outcomes (3)

• Duration of mechanical ventilation

  Up to 28 days

• Pediatric intensive care unit length of stay

  Up to 28 days

• Incidence of mortality

  Up to 28 days

Study Arms (2)

Group I

EXPERIMENTAL

Critically ill ventilated children will receive standard management plus probiotics.

Drug: Probiotics

Group II

ACTIVE COMPARATOR

Critically ill ventilated children will receive standard management only.

Other: Standard management

Interventions

Probiotics DRUG

Critically ill ventilated children will receive standard management plus probiotics.

Group I

Standard management OTHER

Critically ill ventilated children will receive standard management only.

Group II

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Critically ill children from 1 month to 18 years.
• Both sexes.
• Ventilated not due to chest infection.

You may not qualify if:

• Children recently received enteral vaccines.
• Children receiving chronic immunosuppressive such as chemotherapy agents. and immunosuppressive medications, and high dose corticosteroids (more than 1 milligram per kilogram).
• Children with contraindications of enteral feeding.
• Children with gastrointestinal bleeding.
• Children with open wounds following major surgery.
• Children with short gut syndrome.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, Al Gharbia, 31739, Egypt

RECRUITING

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Yomna G El-Feky, MD

CONTACT

00201005562005; Youmna.elfeky@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Pediatrics, Faculty of Medicine, Tanta University, Egypt.

Study Record Dates

• First Submitted: September 19, 2026
• First Posted: September 29, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)