Pneumonia Clinical Trial
— ELUSOfficial title:
Effectiveness of Point-of-care Lung Ultrasound vs Chest X-ray for the Management of Childhood Lower Respiratory Infections in Low-resource Setting: Single Center, Pragmatic, Open-label, Randomized, Controlled, Non-inferiority Clinical Trial
The goal of this clinical trial is to evaluate the effectiveness of point-of-care lung ultrasound versus chest X-ray for the management of childhood lower respiratory infections in a low-resource setting. The main question it aims to answer is: Is point-of-care lung ultrasound as effective as chest X-ray for the management of childhood LRIs in a low-resource setting? Participants will be assigned to either a point-of-care lung ultrasound group (intervention) or a chest X-ray group (control), to compare the effect on overall case management and various clinical outcomes (time to symptom resolution, rate of antibiotic use, length of stay, treatment costs).
Status | Not yet recruiting |
Enrollment | 616 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Months to 16 Years |
Eligibility | Inclusion Criteria: - Children with a suspected lower respiratory infection (LRI) brought to the outpatient or emergency department, - Requiring chest image for evaluation at baseline. Exclusion Criteria: - Children already hospitalized, received antibiotics, or had chest imaging at the hospital; - Follow-up (treated within the past 4 weeks) or referred cases; - Critical patients requiring emergency life-saving support including oxygen; - Children with one or more danger signs (lethargy or loss of consciousness, convulsion, unable to eat or vomiting everything, cyanosis, excess irritability) |
Country | Name | City | State |
---|---|---|---|
Nepal | Siddhi Memorial Hospital | Bhaktapur | Bagmati |
Lead Sponsor | Collaborator |
---|---|
Nagasaki University | London School of Hygiene and Tropical Medicine, Siddhi Memorial Foundation |
Nepal,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correct management plan at the baseline on the basis of clinical assessment and chest image findings | Proportion of participants who are prescribed a correct management plan at the baseline on the basis of clinical assessment and chest image findings, either point-of-care lung ultrasound or chest X-ray | From the date of randomization until the final disposition of patient (i.e. discharge, refer), assessed up to 3 weeks. In case of non-hospitalized participants, outcomes evaluated during 2nd follow up (day 7-10 of enrollment), assessed up to 2 weeks. | |
Secondary | Change in diagnosis and management plan | Diagnosis and Management Plan 1: Enrolling physician will fill a case report form with initial diagnosis and management plan (plan 1) based on the clinical assessment and LUS/CXR findings at baseline.
Decision regarding actual diagnosis and management plan (1a) is on treating physician's discretion. Diagnosis and Management Plan 2: Enrolling physician will fill a second case report form (exactly same to the first one) on Day3-5 of enrollment with the diagnosis and management plan based on clinical assessment, chest image(s), and lab investigations. This outcome is measured in hospitalized cases only. |
From the date of randomization until Day3-5 of enrollment, assessed up to 1 week. | |
Secondary | Time to symptom/sign resolution | In hospitalized cases only | From the date of randomization until disposition (i.e. discharge, referral) or symptom resolution criteria is met, whichever is earlier, assessed up to 3 weeks. | |
Secondary | Length of stay at hospital | In hospitalized cases only | From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks. | |
Secondary | Rate of antibiotic use | In hospitalized cases only | From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks. | |
Secondary | In-hospital treatment costs | In hospitalized cases only | From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks. |
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