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RecruitingNCT07848165Updated Sep 29, 2026

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

An interventional study of Probiotics and Standard management in Probiotic, Ventilator Associated Pneumonia and Critically- Ill Children, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
1 Month to 18 Years
Sex
All
01

Study 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.

Read the detailed description

Critically ill children are the children whom requiring, or potentially requiring, high reliance or serious consideration whether in medical, surgical or trauma-related fields.

Based on the time of onset of Ventilator Associated Pneumonia (VAP), it can be divided into two types. Early-onset VAP occurs during the first four days of mechanical ventilation and is usually caused by antibiotic sensitive bacteria. Late-onset VAP develops five or more days after initiation of MV and is caused by multidrug-resistant (MDR) pathogens .VAP is associated with a high rate of all-cause mortality and a prolonged duration of mechanical ventilation and intensive care unit stay.

02

Conditions studied

  • Probiotic
  • Ventilator Associated Pneumonia
  • Critically- Ill Children
03

Who can participate

Ages eligible
1 Month to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    Group I

    Critically ill ventilated children will receive standard management plus probiotics.

    Drug: Probiotics

  • Active comparator
    Group II

    Critically ill ventilated children will receive standard management only.

    Other: Standard management

Interventions

  • DrugProbiotics

    Critically ill ventilated children will receive standard management plus probiotics.

  • OtherStandard management

    Critically ill ventilated children will receive standard management only.

05

What researchers measure

Primary outcomes

  1. Incidence of ventilator-associated pneumonia

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

    Time frame: During the first 28 days after initiation of mechanical ventilation

Secondary outcomes

  1. Duration of mechanical ventilation

    Duration of invasive mechanical ventilation will be measured in days from initiation of mechanical ventilation until successful extubation.

    Time frame: Up to 28 days

  2. Pediatric intensive care unit length of stay

    Pediatric intensive care unit (PICU) length of stay will be measured in days from PICU admission until PICU discharge.

    Time frame: Up to 28 days

  3. Incidence of mortality

    Incidence of mortality will be recorded.

    Time frame: Up to 28 days

06

Study locations

1 of 1 sites recruiting
07

References and documents

Individual participant data

Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07848165
Lead sponsor
Tanta University
Responsible party
Yomna Gaber El-Feky (Lecturer of Pediatrics, Faculty of Medicine, Tanta University, Egypt., Tanta University) — Principal investigator
First posted
Sep 29, 2026
Start date
Jul 1, 2026
Primary completion
Feb 1, 2027 (estimated)
Completion
Feb 1, 2027 (estimated)
Last update
Sep 29, 2026

Study contacts

Yomna G El-Feky, MD
Contact
Youmna.elfeky@med.tanta.edu.eg
00201005562005

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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