Ignite Creation Date:
2024-05-06 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03556488
Status:
RECRUITING
Last Update Posted:
2024-02-13
First Post:
2018-06-04
Brief Title:
Ultrasonographic Air Bronchogram in Pediatric CAP
Sponsor:
Catholic University of the Sacred Heart
Organization:
Catholic University of the Sacred Heart
Study Overview
Official Title:
Prognostic Role of Ultrasonographic Air Bronchogram in the Management of Community Acquired Pneumoniae in Children
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
USINCHILD
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None