Diagnostic Accuracy of Lung Ultrasound for Pneumonia Diagnosis in Children

Nagasaki University320 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

320

Conditions

Pneumonia Childhood Pneumonia

Interventions

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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