NCT07331311

Diagnostic Accuracy of Lung Ultrasound for Pneumonia Diagnosis in Children

Evaluation of Diagnostic Benefit and Feasibility of Using Lung Ultrasound to Diagnose Childhood Pneumonia in Low-resource Settings

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Nagasaki University · Academic / Other
• Sex: All
• Age: 2 Months – 5 Years
• Healthy volunteers: Not accepted

Summary

Chest X-ray is historically being used as an imaging standard to aid to the diagnosis of childhood pneumonia, however, the evidence does not support it as a perfect imaging tool. As an alternative to CXR, lung ultrasound (LUS) could be used as the imaging of choice in children and studies have demonstrated its good accuracy to diagnose childhood pneumonia. However, most diagnostic studies have used CXR as a reference standard. In absence of a 'gold standard' approach, there is a risk that large proportion of children with pneumonia and severe pneumonia could be 'missed' if clinicians relied on LUS only. This research aims to evaluate the diagnostic benefit of LUS in children compared against 'gold standard' diagnosis which is derived based on the clinical information, imaging and laboratory investigations.

Conditions

• Pneumonia
• Childhood Pneumonia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	LUS as a chest imaging tool	Each study participant receives LUS scan followed by CXR as chest imaging modality. LUS is the diagnostic test under investigation, compared against clinical gold standard (described later).

Timeline

• Start date: 2024-11-19
• Primary completion: 2025-05-15
• Completion: 2025-06-30
• First posted: 2026-01-09
• Last updated: 2026-01-09

Locations

1 site across 1 country: Nepal