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.
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.
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.
Parallel
Bronchoalveolar lavage
Procedure/SurgeryThe child received standard pneumonia treatment and in addition, bronchoalveolar lavage was performed.
Success rate of respiratory support de-escalation
The proportion of patients who received respiratory support (such as mechanical ventilation, high-flow oxygen therapy, etc.) and implemented a strategy of gradually reducing the level of support, successfully transitioning to lower-level support or completely discontinuing respiratory support, and not requiring re-introduction of higher-level support within the specified time. (1) Intubated patients from enrollment to successful extubation (after extubation, stable spontaneous breathing, SpO2 ≥ 92% for more than 24 hours without the need for re-intubation); (2) Oxygen-supplied/ non-invasive respiratory support children from enrollment to no longer requiring oxygen supply (SpO2 ≥ 92% for more than 24 hours) or the respiratory support level being reduced to nasal cannula low flow (≤ 2L/min).
Click on the lead sponsor to view all of their trials.
The Children's Hospital of Zhejiang University School of Medicine
Lead sponsor
Shanghai Feihong Medical Technology Co., Ltd.
Collaborator
Zhuhai Huaguang Medical Technology Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
