CompletedNot Applicable

Flexible Bronchoscopy in Resistant Pneumonia in PICU

Egypt70 participantsStarted 2023-02-05

Plain-language 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.

Who can participate

Age range

3 Months – 14 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Trial details

NCT IDNCT07421440

SponsorMansour Gomaa Mohammed Saleh

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-29

View on ClinicalTrials.gov More Pneumonia trials