An interventional study of LUS as a chest imaging tool in Pneumonia and Childhood Pneumonia, sponsored by Nagasaki University. Completed at 1 site in Nepal. Open to participants aged 2 Months to 5 Years. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by Nagasaki University · Not applicable, Interventional, and Diagnostic
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.
1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.
This study's enrollment of 320 is above the median of 129 across 975 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Nagasaki University is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Single arm study that evaluates the role of LUS in diagnosing pneumonia in children. All participants receive LUS scans followed by CXR as chest imaging intervention.
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).
Pneumonia missed by LUS
Proportion of children with any pneumonia (severe or non-severe) that would be missed by LUS at initial presentation
Time frame: From enrolment until day-5 follow up
Pneumonia missed by CXR
Proportion of children with any pneumonia (severe or non-severe) that would be missed by CXR at initial presentation
Time frame: From enrolment until day-5 follow up
Diagnostic accuracy of LUS
Sensitivity and specificity of LUS for pneumonia diagnosis in children, compared against 'Gold standard' diagnosis adjudicated by expert paediatrician panel after reviewing all available clinical information about the child during study time frame
Time frame: From enrolment to day-5 follow up
Diagnostic accuracy of CXR
Sensitivity and specificity of CXR for pneumonia diagnosis in children, compared against 'Gold standard' diagnosis adjudicated by expert paediatrician panel after reviewing all available clinical information about the child during study time frame
Time frame: From enrolment to day-5 follow up
Proportion of 'missed pneumonia' cases with adverse clinical outcomes
List of adverse clinical outcomes and their measures: 1. 'Clinical worsening' - defined as change from non-severe pneumonia to severe pneumonia status; 2. 'Development of pulmonary complications' - defined as development of pleural effusion, empyema, pneumatocele, TB or respiratory failure/ARDS requiring ventilator support for the current episode of illness; 3. 'ICU admission' - defined as requiring ICU care for current episode of illness; 4. 'Revisit or readmission' - defined as unscheduled ER visit and/ or readmission within 4 weeks of initial visit for current episode of illness; 5. 'Prolonged hospitalisation' - defined as hospitalisation for more than 5 days; 6. 'Mortality' - if the child died due to current episode of illness
Time frame: From day of enrolment to day-5 follow up
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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