Ultrasonographic Air Bronchogram in Pediatric CAP (USINCHILD)

February 12, 2024 updated by: Riccardo Inchingolo, Catholic University of the Sacred Heart

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli
        • Contact:
        • Sub-Investigator:
          • Rafael Emanuele Gerardi, M.D.
        • Sub-Investigator:
          • Andrea Smargiassi, M.D., Ph.D.
        • Sub-Investigator:
          • Emanuele Conte, M.D.
        • Sub-Investigator:
          • Antonio Gatto, M.D.
        • Sub-Investigator:
          • Piero Valentini, Prof., M.D.
        • Sub-Investigator:
          • Chiara Pierandrei, M.D.
        • Sub-Investigator:
          • Lavinia Capossela, M.D.
        • Sub-Investigator:
          • Giuseppe M Corbo, Prof., M.D.
      • Trieste, Italy
        • Recruiting
        • Azienda Sanitaria Universitaria Integrata di Trieste - Ospedale di Cattinara
        • Contact:
        • Principal Investigator:
          • Roberto Copetti, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with a clinical diagnosis of CAP and radiographic evidence of lung consolidation.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pediatric CAP
Patients with a clinical diagnosis of CAP and radiographic evidence of lung consolidation, hospitalized in the Pediatric Unit.
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catholic University of the Sacred Heart

Investigators

  • Study Director: Luca Richeldi, Prof,MD,PhD, Fondazione Policlinico Universitario A. Gemelli, IRCCS
  • Principal Investigator: Riccardo Inchingolo, MD, PhD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2018

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

June 4, 2018

First Posted (Actual)

June 14, 2018

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13528/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pneumonia

Clinical Trials on US air bronchogram score

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in France

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe