659 Participants NeededMy employer runs this trial

Lung Ultrasound for Childhood Pneumonia

(LUSCAP Trial)

Recruiting at 17 trial locations
NP
MC
Overseen ByMartina Cecchetti, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

NP

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

I have breathing problems like cough, shortness of breath, or abnormal lung sounds.
I have symptoms like fever, low oxygen, or loss of appetite.
No eligibility criterion provided.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomized to either the experimental group with lung ultrasound or the control group with standard care

1 day
1 visit (in-person)

Follow-up

Participants are monitored for clinical progress and antibiotic use post-discharge

1 week
Follow-up call 5-7 days 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

Group I: Experimental Group - Lung Ultrasound (LUS)Experimental Treatment1 Intervention
Group II: Control group - standard of careActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Meyer Children's Hospital IRCCS

Lead Sponsor

Trials
62
Recruited
17,500+

Gaslini Children's Hospital

Collaborator

Trials
7
Recruited
107,000+

Consiglio Nationale delle Richerche (CNR)

Collaborator

Trials
2
Recruited
550+

IRCCS Burlo Garofolo

Collaborator

Trials
95
Recruited
67,300+

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Collaborator

Trials
748
Recruited
1,386,000+

Università degli Studi 'G. d'Annunzio' Chieti e Pescara

Collaborator

Trials
17
Recruited
7,800+

Schneider Children's Medical Center, Israel

Collaborator

Trials
29
Recruited
2,013,000+

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Collaborator

Trials
487
Recruited
608,000+

Yale University

Collaborator

Trials
1,963
Recruited
3,046,000+

University Hospital Padova

Collaborator

Trials
47
Recruited
21,800+

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.

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/ ...