Clinical trial NCT03556488: Ultrasonographic Air Bronchogram in Pediatric CAP
Official title: Prognostic Role of Ultrasonographic Air Bronchogram in the Management of Community Acquired Pneumoniae in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumonia
Pediatric Infectious Disorder
Keywords: Chest ultrasound
Pediatric community acquired pneumonia
Air bronchogram
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2018-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a clinical diagnosis of CAP and radiographic evidence of lung consolidation.

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.

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.

Primary outcomes:
measure: Rate of uncomplicated CAP
timeFrame: 48 hours
measure: Time to resolution of fever
timeFrame: Through study completion, an average of 7 days.
measure: Change of antibiotic therapy
timeFrame: 48 hours
measure: Length of hospitalization
timeFrame: Through study completion, an average of 10 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli
city: Trieste
country: Italy
facility: Azienda Sanitaria Universitaria Integrata di Trieste - Ospedale di Cattinara
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Luca Richeldi, Prof,MD,PhD
role: STUDY_DIRECTOR
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Riccardo Inchingolo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.