An interventional study of Point-of-care lung ultrasound and Chest X-ray (digital images) in Lower Respiratory Infection, LRTI and Pneumonia, sponsored by Nagasaki University. Not yet recruiting at 1 site in Nepal. Open to participants aged 2 Months to 16 Years. Per ClinicalTrials.gov, last updated 2023-11-09.
Sponsored by Nagasaki University · Not applicable, Interventional, and Treatment
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).
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.
1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.
This study's planned enrollment of 616 is above the median of 129 across 975 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Nagasaki University is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Point-of-care lung ultrasound
Diagnostic Test: Point-of-care lung ultrasound
Chest X-ray
Diagnostic Test: Chest X-ray (digital images)
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
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
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
Time frame: 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.
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.
Time frame: From the date of randomization until Day3-5 of enrollment, assessed up to 1 week.
Time to symptom/sign resolution
In hospitalized cases only
Time frame: 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
In hospitalized cases only
Time frame: From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.
Rate of antibiotic use
In hospitalized cases only
Time frame: From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.
In-hospital treatment costs
In hospitalized cases only
Time frame: From the date of randomization until disposition (i.e. discharge, referral), assessed up to 3 weeks.
Plan to share: Yes — Study protocol, deidentified participant data, and study tools may be shared with other researchers upon reasonable request, and decided by the investigators.
Supporting information: Study protocol, Clinical study report
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.
No publications or documents are linked to this record.
Start is estimated for Jan 2024; primary completion for Sep 2024, 8 months later.
Of 258 non-industry interventional studies with no phase under Pneumonia, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's planned 8 months is below that.
Counting every sponsor, half of 265 studies reached it within 21 months; a quarter within 10 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Nagasaki University