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Completed

NCT Number: NCT07421440

Flexible Bronchoscopy in Resistant Pneumonia in PICU

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.

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Key information

Age range

3 month–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Abu Elreesh children hospital , faculty of medicine , cairo university

Cairo, Cairo Governorate, Egypt

About this study

Lower respiratory tract infections remain a leading cause of morbidity and mortality among critically ill children admitted to Pediatric Intensive Care Units (PICUs). Despite appropriate empirical antimicrobial therapy, some patients continue to demonstrate persistent clinical and radiological evidence of pneumonia after at least five days of broad-spectrum antibiotic treatment. These patients are considered to have resistant or non-resolving pneumonia and often require additional diagnostic evaluation to identify persistent infection, resistant microorganisms, airway abnormalities, or alternative diagnoses.

Flexible fiberoptic bronchoscopy (FFB) with bronchoalveolar lavage (BAL) permits direct visualization of the tracheobronchial tree and collection of lower respiratory tract specimens for microbiological analysis. In addition to identifying airway abnormalities such as mucus plugging, tracheobronchitis, foreign body aspiration, airway malacia, or extrinsic airway compression, BAL specimens can be analyzed by conventional culture and molecular diagnostic methods to facilitate targeted antimicrobial therapy.

This prospective observational study was conducted in the Pediatric Intensive Care Unit of Abu El-Reesh Children's Hospital, Faculty of Medicine, Cairo University. Children aged 3 months to 14 years with resistant pneumonia who failed to improve clinically or radiologically after at least five days of first-line broad-spectrum antibiotic therapy and underwent clinically indicated flexible fiberoptic bronchoscopy with BAL were enrolled.

Clinical characteristics, laboratory investigations, inflammatory biomarkers, radiological findings, bronchoscopic findings, BAL microbiological results, antimicrobial susceptibility patterns, molecular diagnostic results, treatment modifications, procedure-related complications, and clinical outcomes were recorded and analyzed. The study evaluated the diagnostic yield and clinical utility of FFB with BAL, compared different microbiological diagnostic methods, assessed the impact of bronchoscopy on patient management, and evaluated clinical outcomes including inflammatory marker response, duration of oxygen therapy, length of PICU stay, and survival to PICU discharge.

The findings of this study contribute to understanding the diagnostic performance, safety, and clinical impact of flexible fiberoptic bronchoscopy with bronchoalveolar lavage in the evaluation and management of resistant pneumonia in critically ill pediatric patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • - 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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

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

Secondary outcomes

  1. Clinical improvement after flexible fiberoptic bronchoscopy

    Time frame: 72 hours after bronchoscopy

    Clinical improvement assessed by changes in C-reactive protein (CRP), total leukocyte count (TLC), chest radiographic findings, and oxygen requirement after flexible fiberoptic bronchoscopy.

  2. Microbiological diagnostic performance of bronchoalveolar lavage

    Time frame: Within 7 days after bronchoscopy

    Comparison of bronchoalveolar lavage microbiological findings with sputum culture, blood culture, and molecular testing for pathogen identification.

  3. Clinical outcomes following bronchoscopy

    Time frame: From bronchoscopy until PICU discharge

    Duration of oxygen therapy, length of PICU stay, treatment modification based on bronchoscopy findings, and mortality.

Sponsors and collaborators

Lead sponsor

Mansour Gomaa Mohammed Saleh

Other

Registry information

Official study title

Outcome of Flexible Fiber Optic Bronchoscopy Usage in Children With Resistant Pneumonia in Pediatric Intensive Care Units (PICU )

Acronym: FFP-RP PICU

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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