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

NCT05921526 | Unknown DMC

• 1 other identifier: ELUS study
• Study Type: interventional
• Target: 616
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Lower Respiratory Infection; LRTI; Pneumonia; Bronchiolitis

Keywords

Point-Of-Care Lung UltraSound; POCLUS; Lung POCUS

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in diagnosis and management plan

  From the date of randomization until Day3-5 of enrollment, assessed up to 1 week.

• Time to symptom/sign resolution

  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.

• Length of stay at hospital

  From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.

• Rate of antibiotic use

  From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.

• In-hospital treatment costs

  From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.

Study Arms (2)

Intervention

EXPERIMENTAL

Point-of-care lung ultrasound

Diagnostic Test: Point-of-care lung ultrasound

Control

ACTIVE COMPARATOR

Chest X-ray

Diagnostic Test: Chest X-ray (digital images)

Interventions

Point-of-care lung ultrasound DIAGNOSTIC_TEST

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

Also known as: POCLUS

Intervention

Chest X-ray (digital images) DIAGNOSTIC_TEST

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.

Also known as: CXR

Control

Eligibility Criteria

• Age: 2 Months - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with a suspected lower respiratory infection (LRI) brought to the outpatient or emergency department,
• Requiring chest image for evaluation at baseline.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nagasaki University: lead
• London School of Hygiene and Tropical Medicine: collaborator
• Siddhi Memorial Foundation: collaborator

Study Sites (1)

Siddhi Memorial Hospital

Bhaktapur, Bagmati, 44800, Nepal

Location

MeSH Terms

Conditions

Pneumonia; Bronchiolitis

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Suraj Bhattarai, MBBS, MSc, DTM&H

  LSHTM/Nagasaki U/Siddhi Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Bhim Dhoubhadel, MBBS MTM PhD DipPaed DTM&H

  Nagasaki University

  PRINCIPAL INVESTIGATOR

• Shunmay Yeung, PhD MBBS FRCPCH MRCP DTM&H

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bhattarai

CONTACT

+977 9849158460; Suraj.Bhattarai@lshtm.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Fellow

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 27, 2023
• Study Start: January 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Study protocol will be published in a journal. Clinical study report may be shared after the study is closed.
• Access Criteria: It will be decided by the team of principle investigators.

Locations

NE (1)