Ultrasonographic Air Bronchogram in Pediatric CAP

Study Overview
=================
Brief Summary
-----------------
This study evaluates the prognostic role of the change of arborescent air bronchogram, a typical ultrasonographic finding of lung consolidation due to pneumonia, in the management of pediatric CAP.

Detailed Description
-----------------
This is a single-center prospective study to evaluate the prognostic role of the change of arborescent air bronchogram, a typical ultrasonographic finding of lung consolidation due to pneumonia, in the management of CAP in terms of: 1) impact on rate of uncomplicated respiratory infections [rate of uncomplicated CAP], 2) relationship to the time of resolution of clinical signs [time to resolution of fever], 3) change of antibiotic therapy not guided by microbiological examinations and, 4) length of hospitalization. At admission, the Pediatric will evaluate clinical signs of respiratory distress, request microbiologic tests (nasopharyngeal swab specimens and pneumococcal urinary antigen) to detect causative pathogens of CAP, and laboratory tests (complete blood cell count, acute-phase reactants C-reactive protein). Finally, all children will undergo chest radiography (CXR). If CXR should be performed before the admission to Pediatric Unit, the radiological exam will be not repeated. Ultrasonographic evaluation will be performed by Pulmonologists. The first examination will be performed within 12 hours from admission. The Pulmonologists will be blind to clinical and radiological data. In order to characterize the lung consolidation, a grading system based on the presence and the features of air bronchogram [static, dynamic, dynamic with areas of lung recruitment] will be adopted. The operator will collect and store images and videos (10seconds), these findings will be reviewed by an expert Clinician in chest US blind to other data. After 48h from the admission, all children will undergo follow-up laboratory tests and lung US. In case of clinical deterioration, children will undergo further ultrasonographic evaluations according pediatric indications. Finally, all children will undergo lung US after 7 ± 2 days from discharge.

Official Title
-----------------
Prognostic Role of Ultrasonographic Air Bronchogram in the Management of Community Acquired Pneumoniae in Children

Conditions
-----------------
Pneumonia, Pediatric Infectious Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: US air bronchogram score


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected CAP Age from 1 to 16 years old Admission to Pediatric Unit Radiographic evidence of lung consolidation Written informed consent from parents Exclusion Criteria: Gestational age < 36 weeks Previous diagnosis of cystic fibrosis Congenital pulmonary disease. Refusal to participate.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric CAP<br>Patients with a clinical diagnosis of CAP and radiographic evidence of lung consolidation, hospitalized in the Pediatric Unit. | Diagnostic Test: US air bronchogram score<br>* On ultrasonographic examination, lung consolidation is defined as a subpleural echo-poor region or one with tissue- like echotexture, depending on the extent of air loss and fluid predominance, which is clearly different from the normal pattern. The air bronchogram is characterized as: absent, static, dynamic, dynamic with areas of lung recruitment.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of uncomplicated CAP | Impact on rate of uncomplicated respiratory infections | 48 hours | 
| Time to resolution of fever | Relationship to the time of resolution of clinical signs | Through study completion, an average of 7 days. | 
| Change of antibiotic therapy | Change of antibiotic therapy not guided by microbiological examinations | 48 hours | 
| Length of hospitalization | Length of hospitalization | Through study completion, an average of 10 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chest ultrasound, Pediatric community acquired pneumonia, Air bronchogram