Lung Ultrasound for Childhood Pneumonia
(LUSCAP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether lung ultrasound can help doctors make better decisions about prescribing antibiotics for children with suspected pneumonia. It aims to determine if lung ultrasound can reduce unnecessary antibiotic use compared to usual methods, which often include chest X-rays and blood tests. The study seeks children aged 3 to 10 who show signs of pneumonia, such as cough or fever, but are otherwise stable and not in severe condition. By identifying a more accurate way to diagnose pneumonia, this trial hopes to improve treatment and reduce antibiotic overuse in children. As an unphased trial, it offers a unique opportunity to contribute to research that could lead to better diagnostic methods for children.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already on antibiotic therapy.
What prior data suggests that lung ultrasound is safe for diagnosing childhood pneumonia?
Research has shown that lung ultrasound provides a safe and effective method for diagnosing pneumonia in children. Studies have found it to be highly accurate and sensitive, effectively detecting pneumonia without causing harm.
Unlike chest X-rays, lung ultrasound does not involve radiation, making it a safer option for children. It is also portable and easy to use. A meta-analysis, which combines results from multiple studies, confirmed that lung ultrasound is both safe and versatile for diagnosing pneumonia in children. No significant side effects have been reported in its use with children.
Overall, lung ultrasound is well-tolerated and serves as a reliable method for checking pneumonia in children.12345Why are researchers excited about this trial?
Researchers are excited about using lung ultrasound (LUS) for childhood pneumonia because it offers a non-invasive, radiation-free alternative to traditional imaging techniques like chest X-rays. Unlike standard methods, LUS can be performed at the bedside, providing immediate insights into a child's lung condition without the need for a trip to the radiology department. This technique could streamline the diagnosis process, making it quicker and safer, especially for young patients who are more sensitive to radiation exposure.
What evidence suggests that lung ultrasound is effective for diagnosing pneumonia in children?
Research has shown that lung ultrasound accurately diagnoses pneumonia in children. Studies have found it correctly identifies pneumonia in most cases, with a sensitivity of up to 96% and a specificity of 93%. This trial will compare lung ultrasound, administered to participants in the experimental group, with the standard of care used in the control group. Lung ultrasound can detect pneumonia without exposing children to radiation. However, it might not always distinguish between bacterial and viral pneumonia, which is crucial for determining the need for antibiotics. Overall, lung ultrasound is a promising method for effectively diagnosing pneumonia in children.24567
Who Is on the Research Team?
Niccolò Parri, MD
Principal Investigator
Meyer Children's Hospital IRCCS, Florence, Italy
Are You a Good Fit for This Trial?
This trial is for children aged 3 to 10 years who are generally healthy and stable, showing signs of pneumonia like cough, fast or difficult breathing, fever, low oxygen levels, or poor appetite. Kids can't join if they're outside this age range, recently hospitalized, already on antibiotics or chest imaging, very sick, or have conditions causing frequent/severe pneumonia.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to either the experimental group with lung ultrasound or the control group with standard care
Follow-up
Participants are monitored for clinical progress and antibiotic use post-discharge
Data Management and Analysis
Data are recorded and stored in REDCap, with pseudonymized patient identifiers
What Are the Treatments Tested in This Trial?
Interventions
- Lung Ultrasound
Trial Overview
The study compares using lung ultrasound versus standard care (clinical exam with possible chest X-ray and blood tests) to guide antibiotic use in kids suspected of having pneumonia. It aims to see if lung ultrasound can help reduce unnecessary antibiotic prescriptions.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Meyer Children's Hospital IRCCS
Lead Sponsor
Gaslini Children's Hospital
Collaborator
Consiglio Nationale delle Richerche (CNR)
Collaborator
IRCCS Burlo Garofolo
Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Collaborator
Università degli Studi 'G. d'Annunzio' Chieti e Pescara
Collaborator
Schneider Children's Medical Center, Israel
Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Collaborator
Yale University
Collaborator
University Hospital Padova
Collaborator
Citations
Lung Ultrasonography Beyond the Diagnosis of Pediatrics ...
However, lung ultrasound showed less sensitivity (78.4%) and specificity (90.4%) for diagnosing viral pneumonia [15]. They finally concluded ...
Lung ultrasound for diagnosing etiology of respiratory ...
Similarly, a meta-analysis found LUS ~ 96% sensitive and 93% specific for pediatric pneumonia, prompting calls for broader LUS use in pediatrics ...
LUS in Pediatric Pneumonia Has Similar Accuracy to Chest ...
Lung ultrasound (LUS) is as effective as chest radiography (CXR) in diagnosing childhood community-acquired pneumonia, according to systematic review and meta- ...
Diagnostic Accuracy of Bedside Lung Ultrasound Versus ...
The findings affirm that LUS is a highly sensitive (86.2%) and specific (94.4%) modality, outperforming CXR in diagnosing pediatric pneumonia.
Diagnostic Accuracy of Lung Ultrasound for Pneumonia ... - PMC
This systematic review and meta-analysis provides strong evidence that LUS is a highly accurate and reliable tool for diagnosing pneumonia in ...
Lung Ultrasound for the Diagnosis of Pneumonia in Children
RESULTS: Five studies (63%) reported using highly skilled sonographers. Overall methodologic quality was high, but heterogeneity was observed across studies.
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healthcare-bulletin.co.uk
healthcare-bulletin.co.uk/article/role-of-lung-ultrasound-in-early-diagnosis-and-severity-assessment-of-paediatric-pneumonia-a-prospective-diagnostic-accuracy-study-4683/Role of Lung Ultrasound in Early Diagnosis and Severity ...
Results: A total of 150 children were enrolled; 90/150 (60.0%) were classified as pneumonia by the composite reference. LUS was positive in 95/ ...
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