Validation of a lung ultrasound approach for diagnosing respiratory issues in children
Validation of the Kinshasa Lung Ultrasound Approach for the Narrowing of Differential Diagnosis in Children Admitted With Acute Respiratory Symptoms in Low-resource Settings
This study is testing a new lung ultrasound method to see if it can help doctors better diagnose breathing problems in children aged 3 months to 14 years in places with limited resources.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 178 (estimated) |
| Ages | 3 Months to 14 Years |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 3 sites (Chittagong and 2 other locations) |
| Trial ID | NCT06839963 on ClinicalTrials.gov |
What this trial studies
This observational study aims to validate the Kinshasa lung ultrasound (K-LUS) approach for diagnosing acute respiratory symptoms in children aged 3 months to 14 years in low-resource settings like the Democratic Republic of Congo and Bangladesh. The K-LUS integrates clinical history, physical examination features, and lung ultrasound findings to improve diagnostic accuracy compared to traditional methods. By comparing the K-LUS derived diagnosis with the initial clinical diagnosis made by treating physicians, the study seeks to enhance the management of respiratory diseases in hospitalized children. The study will also quantify pulmonary aeration and document the frequency of suspected diagnoses.
Who should consider this trial
Good fit: Ideal candidates are children aged 3 months to 14 years who are admitted to the hospital with cough or difficulty breathing.
Not a fit: Patients who are expected to have a short stay in the emergency department or require transfer to other facilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate and timely diagnoses of respiratory diseases in children, improving patient outcomes.
How similar studies have performed: While the use of lung ultrasound in pediatric populations is gaining traction, this specific K-LUS approach is novel and has not been extensively tested in similar settings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Children aged between 3 months and 14 years; * Admitted to the emergency department or ward with cough or difficulty in breathing; Exclusion Criteria: * Expected short stay in the emergency department (\< 6h) * Emergency transfer to other facilities * Refusal of informed consent by attending parent or caregiver, as appropriate * Lung ultrasound not feasible (e.g. non-availability of a trained physician)
Where this trial is running
Chittagong and 2 other locations
- Chittagong Medical College Hospital — Chittagong, Bangladesh (Recruiting)
- Kinshasa School of Public Health, University of Kinshasa — Kinshasa, Congo, The Democratic Republic of the (Not_yet_recruiting)
- Pujehun Govt Hospital Medical — Pujehun, Sierra Leone (Not_yet_recruiting)
Study contacts
- Principal investigator: Luigi Pisani — Mahidol Oxford Tropical Medicine Research Unit Faculty of Tropical Medicine, Mahidol University Thailand
- Study coordinator: Luigi Pisani
- Email: luigipisani@gmail.com
- Phone: 393291525693
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.