Flexible Bronchoscopy in Resistant Pneumonia in PICU

NCT07421440 | Completed

• 1 other identifier: MD-207-2023
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Pneumonia remains a leading cause of morbidity and mortality among critically ill children admitted to Pediatric Intensive Care Units (PICUs). A proportion of patients fail to demonstrate clinical or radiological improvement despite receiving at least five days of appropriate broad-spectrum antibiotic therapy, a condition commonly referred to as resistant or non-resolving pneumonia. These patients often require further diagnostic evaluation to identify persistent infection, resistant microorganisms, airway abnormalities, or alternative diagnoses. Flexible fiberoptic bronchoscopy (FFB) with bronchoalveolar lavage (BAL) is an important diagnostic procedure that permits direct visualization of the tracheobronchial tree and collection of lower respiratory tract specimens for microbiological analysis. The findings obtained through FFB may identify the underlying etiology of persistent pulmonary disease and guide subsequent therapeutic decisions. This observational study aims to evaluate the diagnostic yield, clinical utility, safety, and impact of flexible fiberoptic bronchoscopy with bronchoalveolar lavage in children with resistant pneumonia admitted to the Pediatric Intensive Care Unit at Abu El-Reesh Children's Hospital, Cairo University. Eligible patients are children who demonstrate persistent clinical and radiological evidence of pneumonia despite receiving at least five days of appropriate first-line broad-spectrum antibiotic therapy. Clinical characteristics, bronchoscopic findings, microbiological results, bronchoalveolar lavage cultures, molecular diagnostic results, treatment modifications, procedure-related complications, and clinical outcomes will be analyzed. The findings of this study are expected to provide evidence regarding the role of flexible bronchoscopy in the diagnostic evaluation and management of resistant pneumonia in critically ill pediatric patients.

Conditions

Pneumonia; Resistant Pneumonia; Resistant Pneumonia in Critically Ill Pedaitric Patients

Keywords

Flexible bronchoscopy; bronchoalveolar lavage; pediatric critical care; resistant pneumonia; diagnostic yield

Outcome Measures

Primary Outcomes (1)

• Diagnostic yield of flexible fiberoptic bronchoscopy (FFB) in resistant pneumonia

  Proportion of patients in whom flexible fiberoptic bronchoscopy with bronchoalveolar lavage identifies a specific etiological pathogen (bacterial, viral, or fungal) responsible for resistant pneumonia

  During bronchoscopy and within 72 hours after bronchoscopy where FFB findings were obtained during the procedure and inflammatory markers/chest imaging were reassessed within 72 hours after FFB, with patients followed clinically until PICU discharge

Secondary Outcomes (3)

• Clinical improvement after flexible fiberoptic bronchoscopy

  72 hours after bronchoscopy

• Microbiological diagnostic performance of bronchoalveolar lavage

  Within 7 days after bronchoscopy

• Clinical outcomes following bronchoscopy

  From bronchoscopy until PICU discharge

Study Arms (1)

Children with resistant pneumonia undergoing flexible fiberoptic bronchoscopy

Children admitted to the Pediatric Intensive Care Unit (PICU) with resistant pneumonia who showed no clinical or radiological improvement after at least 5 days of broad-spectrum antibiotic therapy and underwent flexible fiberoptic bronchoscopy with bronchoalveolar lavage as part of their diagnostic evaluation.

Procedure: Flexible fiberoptic bronchoscopy with bronchoalveolar lavage (BAL)

Interventions

Flexible fiberoptic bronchoscopy with bronchoalveolar lavage (BAL) PROCEDURE

Flexible fiberoptic bronchoscopy with bronchoalveolar lavage was performed in all enrolled children with resistant pneumonia as part of the diagnostic evaluation. Bronchoscopy was used for direct airway visualization and bronchoalveolar lavage sample collection for microbiological analysis to guide subsequent clinical management.

Children with resistant pneumonia undergoing flexible fiberoptic bronchoscopy

Eligibility Criteria

• Age: 3 Months - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 3 months to 18 years admitted to the Pediatric Intensive Care Unit at Abu El-Reesh Children's Hospital, Cairo University, with resistant pneumonia who underwent flexible fiberoptic bronchoscopy with bronchoalveolar lavage as part of their diagnostic evaluation

You may qualify if:

• \- Children aged more than 3 months and less than 14 years.
• Admitted to Pediatric Intensive Care Unit (PICU).
• Severe pneumonia defined as cough or difficulty breathing with at least one of the following:
• Oxygen saturation \< 90% on pulse oximetry
• Severe respiratory distress
• General danger signs (inability to drink, lethargy, convulsions)
• No clinical or radiological improvement after at least five days of first-line broad-spectrum antibiotic therapy.
• Informed consent obtained from parent or legal guardian.

You may not qualify if:

• Age less than 3 months or more than 14 years.
• Absolute contraindication to flexible bronchoscopy (severe refractory hypoxemia, hemodynamic instability, uncorrected bleeding disorder).
• refusal of informed consent by parents or legal guardian

Sponsors & Collaborators

• Mansour Gomaa Mohammed Saleh: lead

Study Sites (1)

Abu Elreesh children hospital , faculty of medicine , cairo university

Cairo, Cairo Governorate, Egypt

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Bronchoalveolar Lavage

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assistant lecturer of pediatrics

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 19, 2026
• Study Start: February 5, 2023
• Primary Completion: June 29, 2025
• Study Completion: August 3, 2025
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)