A Multicenter Clinical Study on the Optimization of Timing and Efficacy Evaluation of Bronchoscopic Intervention in Pediatric Severe Pneumonia

Starting soon · Not applicable

Conditions studied: Pediatric Sever Pneumonia

In brief

1. Main objectives: ① To determine the optimal timing for bronchoscopic lung lavage in treating severe pneumonia in children, providing evidence-based guidance for the standardized clinical implementation of this technique. ② To establish a multidimensional efficacy evaluation system encompassing clinical symptoms, blood gas analysis, and inflammatory markers. 2. Secondary objectives: ① To assess the impact of different intervention timings on clinical outcomes, including the time to temperature normalization, resolution of lung rales, length of hospital stay, hospitalization costs, and mortality rate. ② To evaluate the therapeutic effects at the pathophysiological level by measuring inflammatory factors (e.g., IL-6, IL-8), epithelial/endothelial injury biomarkers (e.g., SP-D, angiopoietin-2), and indicators of pathogen clearance, thereby clarifying the treatment's effects on inflammation control, lung injury repair, and pathogen elimination. ③ To enhance the accumulation of safety data by calculating the incidence of adverse events related to bronchoscopic procedures (such as airway bleeding and hypoxemia) and further defining the safety profile of this technique in the pediatric population.

Key facts

Study ID

NCT07437183

Run by

The Children's Hospital of Zhejiang University School of Medicine

People needed

3168

Starts

2026-03-01

Expected to finish

2028-12-31

Last updated by the study team

2026-02-27

Who can join

Age: 0 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• According to the on Clinical Warning and Early Decision-making for Severe Pneumonia in Children, severe pneumonia is diagnosed when any of the following symptoms are present: poor general condition; refusal to eat or dehydration; altered consciousness; significantly increased respiratory rate (RR) (RR > 70 breaths per minute for infants or RR > 50 breaths per minute for older children); central cyanosis; respiratory distress (including groaning, nasal flaring, and use of accessory muscles indicated by three concave signs), involvement of multiple lung lobes or ≥ 2/3 of one lung; pleural effusion; pulse oxygen saturation ≤ 0.92 at sea level; or any extrapulmonary complications. The presence of any of these conditions qualifies as severe pneumonia.
• The time from onset to enrollment was ≤ 72 hours, and the patient had not received bronchoscopic lavage treatment.

You may not qualify if…

• Having severe underlying diseases: congenital heart disease, bronchopulmonary dysplasia, malignant tumors, severe immunodeficiency diseases, etc.
• There are contraindications for performing a bronchoscopy examination.
• Respiratory tract foreign bodies, airway developmental malformations, etc.

Full record on ClinicalTrials.gov

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