Ultrasonographic Air Bronchogram in Pediatric CAP

Pneumonia Clinical Trial

— USINCHILD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03556488
• Other study ID #: 13528/18
• Status: Recruiting
• Start date: May 21, 2018
• Est. completion date: April 30, 2024

Study information

• Verified date: February 2024
• Source: Catholic University of the Sacred Heart
• Contact: Riccardo Inchingolo, MD, PhD
• Phone: +390630154236
• Email: riccardo.inchingolo[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Pediatric Infectious Disorder
• Pneumonia

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli	Roma
Italy	Azienda Sanitaria Universitaria Integrata di Trieste - Ospedale di Cattinara	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

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