Lung Ultrasound for Guiding Antibiotic Use in Pediatric Pneumonia

This prospective, randomized, multicenter clinical trial aims to determine whether using lung ultrasound (LUS) in children aged 3-10 years with suspected pneumonia can reduce the prescription of antibiotics, compared to the standard of care (clinical diagnosis, with optional chest X-ray and blood tests). A second objective is to assess how often LUS findings alter clinical decision-making beyond history and physical examination alone, while a third objective compares the diagnostic accuracy of an LUS-based approach to current pathways.

Study Design and Intervention

Children presenting with signs and symptoms of lower respiratory tract infection (e.g., cough, tachypnea, fever) who are clinically stable and in good general condition are eligible.

Exclusion criteria

include recent hospitalization, prior imaging, ongoing antibiotic therapy, severe respiratory distress, and underlying conditions predisposing to complicated pneumonia.

Participants are randomized to an experimental group, where LUS is performed immediately after clinical assessment, or a control group, which follows standard care.

Clinicians in both groups may request a chest X-ray if warranted, and the reasons for imaging are documented.

All participants receive routine evaluations, and interventions (e.g., blood tests, antibiotic decisions) remain at the discretion of the treating physician.

Outcomes

Primary Outcome: Reduction in antibiotic prescriptions in the LUS group versus the control group.

Secondary Outcomes:

The rate at which LUS modifies diagnoses and clinical management compared to assessments using only history and physical examination.

Differences in emergency department (ED) length of stay, hospital admission rates, and unscheduled healthcare visits within one week.

Overall diagnostic accuracy of LUS-supported diagnosis compared to standard methods.

Additional Measures:

An expert panel (pediatric radiologist, pulmonologist, and emergency physician) will determine a consensus final diagnosis after reviewing clinical data.

Data Management and Follow-Up

Each patient's care pathway is documented using a 1-5 Likert scale capturing the likelihood of pneumonia and willingness to prescribe antibiotics at various decision points (clinical exam, optional LUS, and optional chest X-ray).

A follow-up call occurs 5-7 days post-discharge to track clinical progress and any subsequent antibiotic use.

Data are recorded and stored in REDCap, with pseudonymized patient identifiers.

No significant risks are anticipated. The benefits include potentially improving diagnostic accuracy and reducing unnecessary antibiotic prescriptions.

Ultimately, this study seeks to clarify whether incorporating LUS into standard pediatric pneumonia assessment can enhance decision-making, leading to more judicious antibiotic use without compromising patient care.

Inclusion criteria

• Well-appearing, clinically stable patients aged 3 to 10 years, presenting to the pediatric ED with suspected pneumonia based on a combination of signs and symptoms suggestive of lower respiratory tract infection (LRTI), including:

• Respiratory Symptoms: Cough, Tachypnea, Dyspnea (Increased work of breathing), Abnormal findings on auscultation.
• Systemic Symptoms: Fever, Hypoxia, Decreased appetite.

Exclusion criteria

• Neonates and children up to 3 years of age, and children older than 10 years
• Children aged 3 to 10 years with any of the following factors:

• Recent hospitalization (within the past 14 days)
• Prior CXR or any other chest imaging (e.g. CT scan)
• Ongoing antibiotic therapy
• Hemodynamic instability
• Respiratory failure or severe respiratory distress and/or hypoxemia, requiring urgent assessment for conditions such as pneumothorax, hemothorax, or other emergency respiratory conditions
• History of aspiration or ab ingestis pneumonia
• Underlying medical conditions predisposing to severe or recurrent pneumonia, including immunodeficiency, chronic corticosteroid use, chronic lung disease, malignancy, sickle cell disease, congenital heart disease, tracheostomy, and neuromuscular disorders affecting respiration