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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Sever Pneumonia
• Intervention / Treatment: Procedure: Bronchoalveolar lavage

Detailed Description

(1) Methods: This study is a multicenter, prospective, non-randomized concurrent control study. Participants were grouped based on whether the parents of the children consented to bronchoscopy intervention. Subjects were randomly assigned to the early group, the late group, or the standard treatment group in a 1:1:1 ratio. Random numbers were assigned to subjects according to their order of enrollment.

• Early BALF Group (EB): After the children were diagnosed with severe pediatric pneumonia, bronchoscopic bronchoalveolar lavage combined with standardized basic treatment was performed within 24 hours. Relevant indicators were collected on the first day of enrollment and on the seventh day after treatment.
• Late BALF Group (LB): After the children were diagnosed with severe pediatric pneumonia, bronchoscopic lung lavage combined with standardized basic treatment was performed within 72 hours. Relevant indicators were collected on the day of enrollment and on the seventh day after treatment.

• Standard Treatment Group (ST): Received only standardized basic treatment and did not undergo bronchoscopic lung lavage throughout the study. The same indicators were collected on the first day of enrollment and on the seventh day after treatment.

  (2) Subjects: This study aims to include children aged 1 to 14 years who are clinically diagnosed with severe pneumonia between December 2025 and December 2028. Patient sources include children with severe pneumonia admitted to general internal medicine departments or pediatric intensive care units (PICUs) at each research center.

  (3) Process:

  1. Pre-screening Before Enrollment: ①Collection of basic information; ② Verification of inclusion and exclusion criteria; ③Signing the informed consent form.
  2. Baseline Assessment: ①Age, gender, and weight; ②Onset time, pathogen type, hospitalization duration, hospitalization cost, and mortality rate; ③Form of respiratory support (mechanical ventilation, non-invasive ventilation, mask, or nasal cannula); ④Clinical symptoms and signs, including body temperature and pulmonary rales); ⑤Laboratory tests: blood gas analysis; complete blood count; C-reactive protein (CRP); procalcitonin (PCT); interleukins IL-6 and IL-8; tumor necrosis factor-alpha (TNF-α); surfactant protein D (SP-D); and angiopoietin-2; ⑥ Extent of pulmonary involvement on imaging (multilobar or single-lobe involvement); ⑦Complications of bronchial alveolar lavage.
  3. Intervention Measures: All children receive the standardized basic treatment recommended in the "Clinical Diagnosis and Treatment Guidelines for Community-Acquired Pneumonia in Children (2019 Edition). early group and the late group receive bronchial lung alveolar lavage therapy. The specific procedures are as follows:
• Standardized Basic Treatment: ①Anti-infection treatment: Based on pathogen detection results (such as sputum culture or nucleic acid testing) or clinical experience, select appropriate antibacterial drugs (e.g., cephalosporins, macrolides) or antiviral drugs (e.g., oseltamivir, acyclovir). Administer primarily via intravenous infusion, with dosage calculated according to the child's weight (mg/kg) and frequency following the drug's instructions. ②Respiratory support treatment: Provide nasal cannula high-flow oxygen therapy (flow rate 5-8 L/min), non-invasive ventilation (e.g., bilevel positive airway pressure, with pressure set at 8-12 cmH₂O), or invasive mechanical ventilation (tidal volume 6-8 mL/kg, respiratory rate adjusted according to age). ③Symptomatic supportive treatment: Administer ambroxol (intravenous infusion, 7.5-15 mg per dose, 2-3 times daily) for expectoration; gamma globulin (intravenous infusion, 400-800 mg/kg/day for 3-5 days) to regulate immunity; nebulization therapy (budesonide, ipratropium bromide, salbutamol hydrochloride); enteral or parenteral nutrition support (e.g., amino acids, fat emulsion); and maintain water and electrolyte balance (e.g., fluid replacement, correction of acid-base disorders). Continuously monitor heart rate, blood pressure, and SpO₂. If SpO₂ falls below 85% or arrhythmia occurs, immediately suspend the procedure, provide high-concentration oxygen therapy until vital signs stabilize, and then re-evaluate.

• Unified Standard for Alveolar Lavage Operation: All centers use commonly available pediatric electronic bronchoscopes (outer diameter 4.0-4.2 mm, operating channel 2.0 mm; or outer diameter 2.8-3.2 mm, operating channel 1.2 mm). The bronchoscope is inserted through the nasal or tracheal intubation route to locate the lesion in the lung segment under direct visualization. The lavage dose follows the "Guidelines for Pediatric flexible Bronchoscopy (2018 Edition)": after the bronchoscope is positioned in the target bronchus, 37°C normal saline (1 mL/kg per instillation, maximum 20 mL per instillation, total ≤ 5-10 mL/kg) is injected through the working channel. The lavage fluid is then aspirated using negative pressure of 100-200 mmHg (1 mmHg = 0.133 kPa). The selected negative pressure should be appropriate to avoid bronchial collapse during aspiration. The collected lavage fluid is sent to the laboratory for standardized testing. Throughout the procedure, continuous monitoring of heart rate, blood pressure, and SpO₂ is performed. If SpO₂ falls below 85% or arrhythmia occurs, the procedure should be immediately suspended, and high-concentration oxygen therapy administered until vital signs stabilize before re-evaluation.

  (4) Follow-Up Assessment:The period from enrollment to the collection of clinical data and laboratory indicators in this study was one week. After enrollment, the subjects were required to complete two visits: one at the end of the first week after discharge and another one month after discharge.

  • Visit 1: One week after discharge

    ① Assessment of clinical symptoms and signs, including body temperature, cough, wheezing, lung auscultation, SpO₂ monitoring, feeding, and mental state.

    • Complete Blood Count and C-Reactive Protein (CRP) Test

  • Visit 2: One month after discharge

    • Assessment of clinical symptoms and signs, including body temperature, cough, wheezing, lung auscultation, SpO₂ monitoring, feeding, and mental state; ② Complete blood count with CRP test and chest X-ray examination.

• Study Type: Interventional
• Enrollment (Estimated): 3168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lei Wu; Phone Number: 86-13588727906; Email: zjuent@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. The time from onset to enrollment was ≤ 72 hours, and the patient had not received bronchoscopic lavage treatment.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early BALF Group, EB; After the child was diagnosed with severe pediatric pneumonia, bronchoscopic alveolar lavage combined with standardized basic treatment was carried out within 24 hours. Relevant indicators were collected on the first day of enrollment and on the 7th day after treatment.	Procedure: Bronchoalveolar lavage; The child received standard pneumonia treatment and in addition, bronchoalveolar lavage was performed.
Experimental: Late BALF Group, LB; After the child was diagnosed with severe pediatric pneumonia, bronchoscopic alveolar lavage combined with standardized basic treatment was performed within 72 hours. Relevant indicators were collected on the day of enrollment and on the seventh day after treatment.	Procedure: Bronchoalveolar lavage; The child received standard pneumonia treatment and in addition, bronchoalveolar lavage was performed.
No Intervention: Standard treatment group, ST; Only received standardized basic treatment, without performing bronchoscopic alveolar lavage throughout the process. Also collected relevant indicators on the first day of enrollment and on the 7th day after treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	7 days after treatment

Collaborators and Investigators

• Sponsor: The Children's Hospital of Zhejiang University School of Medicine
• Collaborators: Shanghai Feihong Medical Technology Co., Ltd.; Zhuhai Huaguang Medical Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Investigative Techniques; Therapeutic Irrigation; Bronchoalveolar Lavage
• Other Study ID Numbers: 2025-IRB-0562-P-01; CHZJU2025IIT012 (Other Grant/Funding Number: Children's Hospital of Zhejiang University School of Medicine IIT Project Fund)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: ll relevant data supporting the findings of this study can be accessed upon reasonable request from the Project Manager at zjuent@zju.edu.cn.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No