Flexible Bronchoscopy in Resistant Pneumonia in PICU (FFP-RP PICU)

July 16, 2026 updated by: Mansour Gomaa Mohammed Saleh

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt
        • Abu Elreesh children hospital , faculty of medicine , cairo university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
72 hours after bronchoscopy
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.
Within 7 days after bronchoscopy
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.
From bronchoscopy until PICU discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansour Gomaa Mohammed Saleh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 3, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MD-207-2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly shared because the study contains patient-level clinical data and no formal data-sharing plan has been established.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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