Diagnostic Accuracy of Lung Ultrasound for Pneumonia Diagnosis in Children (LUS)

Nagasaki University

Status: Completed

Conditions: Childhood Pneumonia; Pneumonia

Treatments: Diagnostic Test: LUS as a chest imaging tool

Study type: Interventional

Funder types: Other

Identifiers

NCT07331311

31322 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: All

Ages: 2 months to 5 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical suspicion of pneumonia. Pneumonia is suspected in a child meeting the WHO case definition of pneumonia, i.e. cough or difficulty breathing associated with fast breathing and/ or lower chest wall indrawing.

Exclusion criteria

• Non-consenting parents.
• Children who are hospitalized for more than 24 hours.
• Children treated for pneumonia at the study site within past 4 weeks.
• Critical patients requiring emergency lifesaving support and parents unable to cooperate to provide consent.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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320 participants in 1 patient group

Chest imaging

Experimental group

Description:

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.

Treatment:

Diagnostic Test: LUS as a chest imaging tool