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

NCT07001163 | Completed

• 1 other identifier: Probiotics in neonatal VAP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ventilator Acquired Pneumonia

Keywords

VAP, NICU

Outcome Measures

Primary Outcomes (1)

• VAP incidence rate

  Evaluation of the role of probiotics in the Prevention of neonatal VAP and examining their impact on the incidence of VAP at those neonates.

  one year

Secondary Outcomes (2)

• GIT manifestations

  one year

• Duration of MV and NICU stay

  one year

Study Arms (2)

Probiotic group

ACTIVE COMPARATOR

40 ventilated neonates who received commercially available probiotics

Dietary Supplement: Probiotic

Non-probiotic group

NO INTERVENTION

40 ventilated neonates who only received the standard of care treatment

Interventions

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.

Probiotic group

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All term neonates who required mechanical ventilation with ETT for more than 48 hours.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lamiaa Khaled Zidan: lead

Study Sites (1)

Faculty of Medicine, Tanta University

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

Location

Related Publications (4)

• Bondarev DJ, Ryan RM, Mukherjee D. The spectrum of pneumonia among intubated neonates in the neonatal intensive care unit. J Perinatol. 2024 Sep;44(9):1235-1243. doi: 10.1038/s41372-024-01973-9. Epub 2024 May 2.

  PMID: 38698211 BACKGROUND

• Iqbal F, Siva N, Kolibylu Raghupathy M, Edward S Lewis L, Barche A, Purkayastha J, S Nayak B. Probiotic effect in preterm neonates with sepsis - A systematic review protocol. F1000Res. 2024 Jul 5;11:913. doi: 10.12688/f1000research.122226.3. eCollection 2022.

  PMID: 39114384 BACKGROUND

• Rangelova V, Kevorkyan A, Raycheva R, Krasteva M. Ventilator-Associated Pneumonia in the Neonatal Intensive Care Unit-Incidence and Strategies for Prevention. Diagnostics (Basel). 2024 Jan 23;14(3):240. doi: 10.3390/diagnostics14030240.

  PMID: 38337756 BACKGROUND

• Khodair HA, Elmahdy HS, Zidan LK, Elashry SM, Elmashad AEM. Assessment of the role of probiotics in prevention of ventilator-associated pneumonia in neonates. Eur J Pediatr. 2025 Sep 4;184(9):597. doi: 10.1007/s00431-025-06380-6.

  PMID: 40906025 DERIVED

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: May 23, 2025
• First Posted: June 3, 2025
• Study Start: May 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: June 1, 2024
• Last Updated: June 3, 2025

Record last verified: 2025-05

Locations

EG (1)