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Completed

NCT Number: NCT07331311

Diagnostic Accuracy of Lung Ultrasound for Pneumonia Diagnosis in Children

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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Key information

Conditions

Pneumonia Childhood Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

2 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Siddhi Memorial Hospital

Bhaktapur, Bagmati, Nepal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LUS as a chest imaging tool

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).

Primary outcomes

  1. Pneumonia missed by LUS

    Time frame: From enrolment until day-5 follow up

    Proportion of children with any pneumonia (severe or non-severe) that would be missed by LUS at initial presentation

  2. Pneumonia missed by CXR

    Time frame: From enrolment until day-5 follow up

    Proportion of children with any pneumonia (severe or non-severe) that would be missed by CXR at initial presentation

Secondary outcomes

  1. Diagnostic accuracy of LUS

    Time frame: From enrolment to day-5 follow up

    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

  2. Diagnostic accuracy of CXR

    Time frame: From enrolment to day-5 follow up

    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

Other outcomes

  1. Proportion of 'missed pneumonia' cases with adverse clinical outcomes

    Time frame: From day of enrolment to day-5 follow up

    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

Sponsors and collaborators

Lead sponsor

Nagasaki University

Other

Collaborators

  • Global Health Research and Medical Interventions Institute (GlohMed), Nepal
  • London School of Hygiene and Tropical Medicine

Registry information

Official study title

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

Acronym: LUS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 9, 2026
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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