Clinical trial NCT05921526: Effectiveness of Point-of-care Lung Ultrasound for the Management of Childhood Lower Respiratory Infections
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Respiratory Infection
LRTI
Pneumonia
Bronchiolitis
Keywords: Point-Of-Care Lung UltraSound
POCLUS
Lung POCUS
Lead sponsor: Nagasaki University
Sponsor class: OTHER
Collaborators: name: London School of Hygiene and Tropical Medicine
name: Siddhi Memorial Foundation
First posted: 2023-06-27
Enrollment: 616
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Correct management plan at the baseline on the basis of clinical assessment and chest image findings
timeFrame: 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:
measure: Change in diagnosis and management plan
timeFrame: From the date of randomization until Day3-5 of enrollment, assessed up to 1 week.
measure: Time to symptom/sign resolution
timeFrame: 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.
measure: Length of stay at hospital
timeFrame: From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.
measure: Rate of antibiotic use
timeFrame: From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.
measure: In-hospital treatment costs
timeFrame: From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.
Other outcomes:
Locations:
city: Bhaktapur
country: Nepal
facility: Siddhi Memorial Hospital
state: Bagmati
Study officials:
affiliation: LSHTM/Nagasaki U/Siddhi Memorial Hospital
name: Suraj Bhattarai, MBBS, MSc, DTM&H
role: PRINCIPAL_INVESTIGATOR
affiliation: Nagasaki University
name: Bhim Dhoubhadel, MBBS MTM PhD DipPaed DTM&H
role: PRINCIPAL_INVESTIGATOR
affiliation: London School of Hygiene and Tropical Medicine
name: Shunmay Yeung, PhD MBBS FRCPCH MRCP DTM&H
role: PRINCIPAL_INVESTIGATOR
References: