PneumoniaLUSNCT07331311
Diagnostic Accuracy of Lung Ultrasound for Pneumonia Diagnosis in Children
A study testing LUS as a chest imaging tool in people with Pneumonia and Childhood Pneumonia, run by Nagasaki University at 1 site in Nepal.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 months to 5 years
- Conditions the study is for
- Pneumonia, Childhood Pneumonia
- What is being tested?
- LUS as a chest imaging tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteNepal
- Study dates
- 19 Nov 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pneumonia, Childhood Pneumonia
- Being tested
- LUS as a chest imaging tool
- Keywords
- Lung ultrasound, Point-of-Care test, Point-of-Care Lung Ultrasound
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUS as a chest imaging toolDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: LUS as a chest imaging tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pneumonia missed by LUS
Proportion of children with any pneumonia (severe or non-severe) that would be missed by LUS at initial presentation
Measured: 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
Measured: From enrolment until day-5 follow up
Secondary outcomes (2)
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
Measured: 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
Measured: From enrolment to day-5 follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start19 Nov 2024
- Primary completion15 May 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Lung ultrasound followed by chest X-ray in all enrolled participants as chest imaging investigation
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nagasaki University
- Sponsor type
- University, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Global Health Research and Medical Interventions Institute (GlohMed), Nepal
- Responsible party
- Principal investigator, Suraj BHATTARAI, Nagasaki University
- Investigators
- Suraj Bhattarai, MBBS, MSc, DTM&H, Principal investigator, London School of Hygiene and Tropical Medicine/ Nagasaki University School of Tropical Medicine and Global Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331311
- Sponsor's protocol ID
- 31322
- Acronym
- LUS
- Status last verified
- Dec 2025
- First submitted
- 16 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Diagnostic Benefit and Feasibility of Using Lung Ultrasound to Diagnose Childhood Pneumonia in Low-resource Settings
- ClinicalTrials.gov ID
- NCT07331311
- Acronym / sponsor ID
- LUS / 31322
- Conditions
- Pneumonia, Childhood Pneumonia
- Keywords
- Lung ultrasound, Point-of-Care test, Point-of-Care Lung Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Nagasaki UniversityUniversity, hospital or other
- Collaborators
- London School of Hygiene and Tropical Medicine, Global Health Research and Medical Interventions Institute (GlohMed), Nepal
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Lung ultrasound followed by chest X-ray in all enrolled participants as chest imaging investigation
| Arm | Type | Receives |
|---|---|---|
| Chest imaging | Experimental | Diagnostic Test: LUS as a chest imaging toolSingle 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. |
Who may qualify
- Ages
- 2 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUS as a chest imaging toolEach 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). | Diagnostic test | Chest imaging |
Primary outcome
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
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
2 secondary outcomes
Diagnostic accuracy of LUS
Time frame: From enrolment to day-5 follow up
Diagnostic accuracy of CXR
Time frame: From enrolment to day-5 follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suraj Bhattarai, MBBS, MSc, DTM&H principal investigator
London School of Hygiene and Tropical Medicine/ Nagasaki University School of Tropical Medicine and Global Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LUS as a chest imaging tool in people with Pneumonia and Childhood Pneumonia, run by Nagasaki University at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pneumonia missed by LUS (time frame: From enrolment until day-5 follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.