About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Respiratory Symptoms: Cough, Tachypnea, Dyspnea (Increased work of breathing), Abnormal findings on auscultation.
Systemic Symptoms: Fever, Hypoxia, Decreased appetite.
Disqualifiers
Neonates and children up to 3 years of age, and children older than 10 years
Recent hospitalization (within the past 14 days)
Prior CXR or any other chest imaging (e.g. CT scan)
Ongoing antibiotic therapy
Trial design
Parallel
Treatments tested in this trial
LUNG ULTRASOUND
Diagnostic testAll 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
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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.
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.
Other outcomes
Percentage of Participants Whose Pneumonia Was Missed by LUS or CXR
Diagnostic accuracy of the 2 different imaging techniques
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.
Comparison of the Length of Stay in the emergency department
Chart review conducted to assess overall length of stay in the ED.
Sponsors and contacts
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Meyer Children's Hospital IRCCS
Lead sponsor
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator
Gaslini Children's Hospital
Collaborator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborator
University Hospital Padova
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Collaborator
Bambino Gesù Hospital and Research Institute
Collaborator
Santobono-Pausilpon Hospital
Collaborator
Asst Degli Spedali Civili Di Brescia
Collaborator
IRCCS Burlo Garofolo
Collaborator
Clinica Pediatrica Università di Novara
Collaborator
Hospital of Prato
Collaborator
Columbia University
Collaborator
Schneider Children's Medical Center, Israel
Collaborator
Yale University
Collaborator
University of Melbourne
Collaborator