Diagnostic Accuracy of Lung Ultrasound for Pneumonia Diagnosis in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-19

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Pneumonia Childhood Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Lung ultrasound followed by chest X-ray in all enrolled participants as chest imaging investigation

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Care provider performing LUS scans are masked of CXR report and clinical information about he participant, other than the case has WHO defined pneumonia

Study Groups

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Chest imaging

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.

Group Type EXPERIMENTAL

LUS as a chest imaging tool

Intervention Type DIAGNOSTIC_TEST

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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

2 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No