An interventional study of LUNG ULTRASOUND in Pneumonia Childhood, Pneumonia and Lung Ultrasound, sponsored by Meyer Children's Hospital IRCCS. Recruiting at 18 sites in 3 countries. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-04-03.
Sponsored by Meyer Children's Hospital IRCCS · Not applicable, Interventional, and Diagnostic
Pneumonia is a major cause of illness and death in children, with an annual incidence of about 3.3 per 1,000 in those under five years old, many requiring hospitalization. The diagnosis is challenging due to the absence of a universally accepted gold standard, leading to variability in emergency settings. Current guidelines recommend diagnosis based on history and physical examination, which do not reliably differentiate pneumonia from other respiratory infections or identify whether it is bacterial or viral in nature. This uncertainty can lead to the unnecessary use of antibiotics.
Commonly used chest X-rays have limitations such as low sensitivity, moderate interobserver reliability, and the inability to distinguish bacterial from viral pneumonia. In contrast, lung ultrasound has shown high sensitivity and specificity for diagnosing pneumonia in children. However, lung ultrasound also cannot reliably distinguish between bacterial and viral causes and might lead to increased antibiotic prescriptions by detecting minor lung consolidations not seen on chest X-rays. Despite these issues, lung ultrasound is widely used in pediatric pulmonary assessment.
The primary objective of the study is to determine if using lung ultrasound for diagnosing pneumonia in children can reduce antibiotic prescriptions compared to the standard care approach-which mainly relies on clinical diagnosis (often supplemented by chest X-ray and blood tests in selected cases). The secondary objective is to assess how frequently lung ultrasound impacts management decisions during a single clinical visit, beyond the information provided by history and physical examination. The third objective is to compare the diagnostic accuracy of lung ultrasound-supported diagnosis with existing diagnostic methods.
The study hypothesizes that lung ultrasound results can act as a decision modifier, similar to other clinical tools and examination findings. However, a lack of consensus on specific lung ultrasound parameters and their clinical correlations contributes to variability in managing suspected pneumonia, potentially leading to antibiotic overuse.
Eligible participants are children aged three to ten years who are in good general condition and clinically stable, presenting with signs and symptoms of lower respiratory tract infection indicative of pneumonia. Exclusion criteria include children outside the specified age range, those recently hospitalized, those who have undergone prior chest imaging, those already on antibiotic therapy, those with severe clinical instability, and those with underlying conditions predisposing them to severe or recurrent pneumonia. These criteria help ensure that the study population represents general pediatric community-acquired pneumonia cases, avoiding biases from high-risk patients.
The ultimate goal of this study is to provide evidence on whether lung ultrasound can serve as a reliable tool to guide antibiotic prescriptions, thereby reducing unnecessary antibiotic use in the management of pediatric pneumonia.
This prospective, randomized, multicenter clinical trial aims to determine whether using lung ultrasound (LUS) in children aged 3-10 years with suspected pneumonia can reduce the prescription of antibiotics, compared to the standard of care (clinical diagnosis, with optional chest X-ray and blood tests). A second objective is to assess how often LUS findings alter clinical decision-making beyond history and physical examination alone, while a third objective compares the diagnostic accuracy of an LUS-based approach to current pathways.
Study Design and Intervention
Children presenting with signs and symptoms of lower respiratory tract infection (e.g., cough, tachypnea, fever) who are clinically stable and in good general condition are eligible.
Exclusion criteria include recent hospitalization, prior imaging, ongoing antibiotic therapy, severe respiratory distress, and underlying conditions predisposing to complicated pneumonia.
Participants are randomized to an experimental group, where LUS is performed immediately after clinical assessment, or a control group, which follows standard care.
Clinicians in both groups may request a chest X-ray if warranted, and the reasons for imaging are documented.
All participants receive routine evaluations, and interventions (e.g., blood tests, antibiotic decisions) remain at the discretion of the treating physician.
Outcomes
Primary Outcome: Reduction in antibiotic prescriptions in the LUS group versus the control group.
Secondary Outcomes:
The rate at which LUS modifies diagnoses and clinical management compared to assessments using only history and physical examination.
Differences in emergency department (ED) length of stay, hospital admission rates, and unscheduled healthcare visits within one week.
Overall diagnostic accuracy of LUS-supported diagnosis compared to standard methods.
Additional Measures:
An expert panel (pediatric radiologist, pulmonologist, and emergency physician) will determine a consensus final diagnosis after reviewing clinical data.
Data Management and Follow-Up
Each patient's care pathway is documented using a 1-5 Likert scale capturing the likelihood of pneumonia and willingness to prescribe antibiotics at various decision points (clinical exam, optional LUS, and optional chest X-ray).
A follow-up call occurs 5-7 days post-discharge to track clinical progress and any subsequent antibiotic use.
Data are recorded and stored in REDCap, with pseudonymized patient identifiers.
No significant risks are anticipated. The benefits include potentially improving diagnostic accuracy and reducing unnecessary antibiotic prescriptions.
Ultimately, this study seeks to clarify whether incorporating LUS into standard pediatric pneumonia assessment can enhance decision-making, leading to more judicious antibiotic use without compromising patient care.
1,564 studies on the registry are indexed under Pneumonia; 265 are open to participants now.
This study's planned enrollment of 659 is above the median of 129 across 975 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Meyer Children's Hospital IRCCS is the lead sponsor of 78 studies on the registry; 55 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Well-appearing, clinically stable patients aged 3 to 10 years, presenting to the pediatric ED with suspected pneumonia based on a combination of signs and symptoms suggestive of lower respiratory tract infection (LRTI), including:
Exclusion Criteria:
Children aged 3 to 10 years with any of the following factors:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects randomly assigned to the control arm will undergo a complete patient history and clinical assessment (the reference standard). If there is clinical uncertainty, the enrolling physician has the option to perform other test such as CXR or blood test.
All subjects randomly assigned to the investigational arm will undergo lung ultrasound (LUS) . The LUS will be performed immediately following a thorough patient history and complete clinical assessment. Ultrasound still images and ultrasound clips will be acquired according to the study protocol. Detailed methodology of the ultrasound examination and parameters is provided as appendix to the study protocol
Diagnostic Test: LUNG ULTRASOUND
All subjects randomly assigned to the investigational arm will undergo lung ultrasound (LUS) . Ultrasound still images and ultrasound clips will be acquired according to the study protocol. Detailed methodology of the ultrasound examination and parameters is provided as appendix to the study protocol
Percentage of participants with antibiotic use
A chart review and follow up phone call made at 1 week (range 5-7 days) to assess whether or not the subject was started on antibiotics during the index ED visit or at a later healthcare visit. The primary objective of this study is to determine if it is possible for LUS to reduce antibiotic prescription when evaluating patients with possible pneumonia. Specifically, an overall reduction of antibiotic when LUS is used as adjunct tool in the
Time frame: 7 days
Percentage of participants who had hospital admission
Chart review and follow up phone call made at 1 week (range 5-7 days) to assess whether or not the subject was admitted during the index ED visit or at a later healthcare visit.
Time frame: 7 days
Percentage of participants with antibiotic use
A chart review and follow up phone call made at 1 week (range 5-7 days) to assess whether or not the subject was started on antibiotics during the index ED visit or at a later healthcare visit. The primary objective of this study is to determine if it is possible for LUS to reduce antibiotic prescription when evaluating patients with possible pneumonia. Specifically, an overall reduction of antibiotic when LUS is used as adjunct tool in the assessment.
Time frame: 7 days
Percentage of Participants Whose Pneumonia Was Missed by LUS or CXR
Diagnostic accuracy of the 2 different imaging techniques
Time frame: 30 days
Comparison of Unscheduled Healthcare Visits
Percentage of participants who had unscheduled healthcare visits after the index ED visit between those subjects who undergo CXR first and those who undergo LUS first.
Time frame: 7 days
Comparison of the Length of Stay in the emergency department
Chart review conducted to assess overall length of stay in the ED.
Time frame: day 1
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Plan to share: No
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