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

NCT07437183 | Not Yet Recruiting DMC

• 2 other identifiers: 2025-IRB-0562-P-01CHZJU2025IIT012
• Study Type: interventional
• Target: 3,168
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 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. 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.

Conditions

Pediatric Sever Pneumonia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Early BALF Group, EB

EXPERIMENTAL

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

Late BALF Group, LB

EXPERIMENTAL

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

Standard treatment group, ST

NO INTERVENTION

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.

Interventions

Bronchoalveolar lavage PROCEDURE

The child received standard pneumonia treatment and in addition, bronchoalveolar lavage was performed.

Early BALF Group, EB; Late BALF Group, LB

Eligibility Criteria

• Age: 1 Month - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

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

MeSH Terms

Interventions

Bronchoalveolar Lavage

Intervention Hierarchy (Ancestors)

Therapeutic Irrigation; Investigative Techniques

Central Study Contacts

Lei Wu

CONTACT

86-13588727906; zjuent@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share