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

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

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 Overview

• Status: Completed
• Conditions: Pneumonia; Childhood Pneumonia
• Intervention / Treatment: Diagnostic test: LUS as a chest imaging tool

• Study Type: Interventional
• Enrollment (Actual): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Bagmati
    • Bhaktapur, Bagmati, Nepal
      • Siddhi Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pneumonia missed by LUS	Proportion of children with any pneumonia (severe or non-severe) that would be missed by LUS at initial presentation	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	From enrolment until day-5 follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	From enrolment to day-5 follow up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of 'missed pneumonia' cases with adverse clinical outcomes	List of adverse clinical outcomes and their measures: 'Clinical worsening' - defined as change from non-severe pneumonia to severe pneumonia status;; '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;; 'ICU admission' - defined as requiring ICU care for current episode of illness;; 'Revisit or readmission' - defined as unscheduled ER visit and/ or readmission within 4 weeks of initial visit for current episode of illness;; 'Prolonged hospitalisation' - defined as hospitalisation for more than 5 days;; 'Mortality' - if the child died due to current episode of illness	From day of enrolment to day-5 follow up

Collaborators and Investigators

• Sponsor: Nagasaki University
• Collaborators: London School of Hygiene and Tropical Medicine; Global Health Research and Medical Interventions Institute (GlohMed), Nepal
• Investigators: Principal Investigator: Suraj Bhattarai, MBBS, MSc, DTM&H, London School of Hygiene and Tropical Medicine/ Nagasaki University School of Tropical Medicine and Global Health

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2024
• Primary Completion (Actual): May 15, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): January 9, 2026

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Lung ultrasound; Point-of-Care test; Point-of-Care Lung Ultrasound
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia
• Other Study ID Numbers: 31322 (BBRF)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No