Diagnostic Accuracy of Lung Ultrasound for Pneumonia Diagnosis in Children

NCT07331311 | Completed

• 1 other identifier: 31322
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pneumonia; Childhood Pneumonia

Keywords

Lung ultrasound; Point-of-Care test; Point-of-Care Lung Ultrasound

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Diagnostic accuracy of LUS

  From enrolment to day-5 follow up

• Diagnostic accuracy of CXR

  From enrolment to day-5 follow up

Other Outcomes (1)

• Proportion of 'missed pneumonia' cases with adverse clinical outcomes

  From day of enrolment to day-5 follow up

Study Arms (1)

Chest imaging

EXPERIMENTAL

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

Interventions

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).

Chest imaging

Eligibility Criteria

• Age: 2 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: collaborator
• Nagasaki University: lead
• Global Health Research and Medical Interventions Institute (GlohMed), Nepal: collaborator

Study Sites (1)

Siddhi Memorial Hospital

Bhaktapur, Bagmati, Nepal

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Suraj Bhattarai, MBBS, MSc, DTM&H

  London School of Hygiene and Tropical Medicine/ Nagasaki University School of Tropical Medicine and Global Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Care provider performing LUS scans are masked of CXR report and clinical information about he participant, other than the case has WHO defined pneumonia
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research fellow (WISE programme)

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

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 9, 2026
• Study Start: November 19, 2024
• Primary Completion: May 15, 2025
• Study Completion: June 30, 2025
• Last Updated: January 9, 2026

Record last verified: 2025-12

Locations

NE (1)