Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2018-05-21
2024-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pediatric CAP
Patients with a clinical diagnosis of CAP and radiographic evidence of lung consolidation, hospitalized in the Pediatric Unit.
US air bronchogram score
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.
Interventions
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US air bronchogram score
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.
Eligibility Criteria
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Inclusion Criteria
* Age from 1 to 16 years old
* Admission to Pediatric Unit
* Radiographic evidence of lung consolidation
* Written informed consent from parents
Exclusion Criteria
* Previous diagnosis of cystic fibrosis
* Congenital pulmonary disease.
* Refusal to participate.
1 Year
18 Years
ALL
No
Sponsors
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Catholic University of the Sacred Heart
OTHER
Responsible Party
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Riccardo Inchingolo
Physician and clinical researcher
Principal Investigators
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Luca Richeldi, Prof,MD,PhD
Role: STUDY_DIRECTOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Riccardo Inchingolo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Locations
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Fondazione Policlinico Universitario A. Gemelli
Roma, , Italy
Azienda Sanitaria Universitaria Integrata di Trieste - Ospedale di Cattinara
Trieste, , Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Inchingolo R, Copetti R, Smargiassi A, Gerardi RE, Conte EG, Corbo GM, Gatto A, Pierandrei C, Capossela L, Lazzareschi I, Valentini P, Demi L. Air bronchogram integrated lung ultrasound score to monitor community-acquired pneumonia in a pilot pediatric population. J Ultrasound. 2021 Jun;24(2):191-200. doi: 10.1007/s40477-020-00547-7. Epub 2021 Jan 6.
Other Identifiers
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13528/18
Identifier Type: -
Identifier Source: org_study_id
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