Childhood Pneumonia, Pneumonia
Conditions
Keywords
Lung ultrasound, Point-of-Care test, Point-of-Care Lung Ultrasound
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.
Interventions
DIAGNOSTIC_TESTLUS 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).
Sponsors
London School of Hygiene and Tropical Medicine
Global Health Research and Medical Interventions Institute (GlohMed), Nepal
Nagasaki University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Care provider performing LUS scans are masked of CXR report and clinical information about he participant, other than the case has WHO defined pneumonia
Intervention model description
Lung ultrasound followed by chest X-ray in all enrolled participants as chest imaging investigation
Eligibility
Sex/Gender
ALL
Age
2 Months to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pneumonia missed by LUS | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of LUS | 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 |
| Diagnostic accuracy of CXR | 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
| Measure | Time frame | Description |
|---|---|---|
| Proportion of 'missed pneumonia' cases with adverse clinical outcomes | From day of enrolment to day-5 follow up | List of adverse clinical outcomes and their measures: 1. 'Clinical worsening' - defined as change from non-severe pneumonia to severe pneumonia status; 2. '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; 3. 'ICU admission' - defined as requiring ICU care for current episode of illness; 4. 'Revisit or readmission' - defined as unscheduled ER visit and/ or readmission within 4 weeks of initial visit for current episode of illness; 5. 'Prolonged hospitalisation' - defined as hospitalisation for more than 5 days; 6. 'Mortality' - if the child died due to current episode of illness |
Countries
Nepal
Outcome results
None listed