Effectiveness of Point-of-care Lung Ultrasound for the Management of Childhood Lower Respiratory Infections

Pneumonia Clinical Trial

— ELUS  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05921526
• Other study ID #: ELUS study
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: September 2024

Study information

• Verified date: May 2023
• Source: Nagasaki University
• Contact: Bhattarai
• Phone: +977 9849158460
• Email: Suraj.Bhattarai[@]lshtm.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

Background: Lower respiratory infections (LRIs) are the leading causes of mortality in children of low-middle income countries (LMICs) including Nepal; pneumonia being the major killer in under-5 population. Often, the cause of mortality is the delay in diagnosis and treatment, particularly when clinical assessments do not hint toward a diagnosis. In resource-limited settings, routine availability of chest X-ray (CXR) service is a challenge, it can be hazardous to children due to exposure to ionizing radiation. The Point-Of-Care Lung UltraSound (POCLUS) could be an alternative solution for the diagnosis and management of LRIs. Studies have already shown that lung ultrasound has a higher sensitivity and specificity than CXR in diagnosing childhood LRIs, however, none of the studies have yet evaluated its role in overall case management. Methods: Prospective, single-center, pragmatic, open-label, randomized, controlled, non-inferiority clinical trial, which will be conducted in the outpatient and emergency departments of a pediatric hospital in Nepal. A total of 616 children with clinical suspicion of LRI and requiring chest imaging will be randomized at 1:1 allocation to the intervention (POCLUS) and control (CXR) arms. Pediatricians will be trained to perform lung ultrasonography in children. Outcomes: Primary outcome is the proportion of 'correctly (effectively) managed' cases. Secondary outcomes include the proportion of cases with 'change in diagnosis and management plan due to intervention', time to symptom resolution, rate of antibiotic use, length of stay, and in-hospital costs, compared between intervention and control groups.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Bronchiolitis
• Communicable Diseases
• Infections
• Lower Respiratory Infection
• LRTI
• Pneumonia
• Respiratory Tract Infections

Intervention

Diagnostic Test:
• Point-of-care lung ultrasound
Participants assigned to the intervention group will receive POCLUS which will be performed by one of the trained pediatricians. The procedure involves 12 views: two anterior views, two lateral views and two posterior views on both chest walls
• Chest X-ray (digital images)
Participants assigned to the chest X--ray group will be sent to the Radiology department to get a CXR (digital) which will be performed by radio technicians like in routine care. Anteroposterior and/or posteroanterior chest images will be obtained. Reading/ reporting of the digital images will be done by both the radiologist and the enrolling pediatrician. The image/ clinical expert review panels (IERP/ CERP) will also have access to the images for review.

Locations

Country	Name	City	State
Nepal	Siddhi Memorial Hospital	Bhaktapur	Bagmati

Sponsors (3)

Lead Sponsor	Collaborator
Nagasaki University	London School of Hygiene and Tropical Medicine, Siddhi Memorial Foundation

Country where clinical trial is conducted

Nepal, 

Outcome

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.