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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-18
SponsorTanta University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Critically ill children from 1 month to 18 years.

Both sexes.

Ventilated not due to chest infection.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Probiotics

    Drug

    Critically ill ventilated children will receive standard management plus probiotics.

  • Standard management

    Other intervention

    Critically ill ventilated children will receive standard management only.

Treatment groups

68 Participants
are divided into 2 treatment groups
Group A: Group IExperimental treatment 1 intervention
Group B: Group IIActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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