PneumoniaUSINCHILDNCT03556488
Ultrasonographic Air Bronchogram in Pediatric CAP
An observational study of Pneumonia and Pediatric Infectious Disorder, run by Catholic University of the Sacred Heart at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Pneumonia, Pediatric Infectious Disorder
- What is being tested?
- US air bronchogram score
- How many people
- 30 participants
- Where
- 2 sitesItaly
- Study dates
- 21 May 2018to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with a clinical diagnosis of CAP and radiographic evidence of lung consolidation.
Who may be able to join
- Suspected CAP
- Age from 1 to 16 years old
- Admission to Pediatric Unit
- Radiographic evidence of lung consolidation
- Written informed consent from parents
Who cannot join
- Gestational age < 36 weeks
- Previous diagnosis of cystic fibrosis
- Congenital pulmonary disease.
- Refusal to participate.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli
Roma, 00168
Riccardo Inchingolo, M.D., Ph.D., +0630154236, riccardo.inchingolo@policlinicogemelli.it
Rafael Emanuele Gerardi, M.D.
- Recruiting
Azienda Sanitaria Universitaria Integrata di Trieste - Ospedale di Cattinara
Trieste
Roberto Copetti, M.D., robcopet@gmail.com
Roberto Copetti, M.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumonia, Pediatric Infectious Disorder
- Being tested
- US air bronchogram score
- Keywords
- Chest ultrasound, Pediatric community acquired pneumonia, Air bronchogram
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US air bronchogram scoreDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric CAP | Patients with a clinical diagnosis of CAP and radiographic evidence of lung consolidation, hospitalized in the Pediatric Unit. Receives: Diagnostic Test: US air bronchogram score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of uncomplicated CAP
Impact on rate of uncomplicated respiratory infections
Measured: 48 hours
Time to resolution of fever
Relationship to the time of resolution of clinical signs
Measured: Through study completion, an average of 7 days.
Change of antibiotic therapy
Change of antibiotic therapy not guided by microbiological examinations
Measured: 48 hours
Length of hospitalization
Length of hospitalization
Measured: Through study completion, an average of 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start21 May 2018
- Primary completion31 Mar 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riccardo Inchingolo, Catholic University of the Sacred Heart
- Investigators
- Luca Richeldi, Prof,MD,PhD, Study director, Fondazione Policlinico Universitario Agostino Gemelli IRCCSRiccardo Inchingolo, MD, PhD, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03556488
- Sponsor's protocol ID
- 13528/18
- Acronym
- USINCHILD
- Status last verified
- Feb 2024
- First submitted
- 4 Jun 2018
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33409860
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Role of Ultrasonographic Air Bronchogram in the Management of Community Acquired Pneumoniae in Children
- ClinicalTrials.gov ID
- NCT03556488
- Acronym / sponsor ID
- USINCHILD / 13528/18
- Conditions
- Pneumonia, Pediatric Infectious Disorder
- Keywords
- Chest ultrasound, Pediatric community acquired pneumonia, Air bronchogram
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 21 May 2018 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 14 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric CAP | – | Diagnostic Test: US air bronchogram scorePatients with a clinical diagnosis of CAP and radiographic evidence of lung consolidation, hospitalized in the Pediatric Unit. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with a clinical diagnosis of CAP and radiographic evidence of lung consolidation.
Key inclusion criteria (5 listed)
- Suspected CAP
- Age from 1 to 16 years old
- Admission to Pediatric Unit
- Radiographic evidence of lung consolidation
- Written informed consent from parents
Key exclusion criteria (4 listed)
- Gestational age < 36 weeks
- Previous diagnosis of cystic fibrosis
- Congenital pulmonary disease.
- Refusal to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| US air bronchogram scoreOn 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. | Diagnostic test | Pediatric CAP |
Primary outcome
Rate of uncomplicated CAP
Time frame: 48 hours
Impact on rate of uncomplicated respiratory infections
Time to resolution of fever
Time frame: Through study completion, an average of 7 days.
Relationship to the time of resolution of clinical signs
Change of antibiotic therapy
Time frame: 48 hours
Change of antibiotic therapy not guided by microbiological examinations
Length of hospitalization
Time frame: Through study completion, an average of 10 days.
Length of hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Derived from this study: PubMed 33409860Inchingolo 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.
- Individual participant dataSharing planned: Undecided
Related trials for Pneumonia
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
COVID - 19, Long COVID Syndrome
RecruitingPhase 3
A Study to Evaluate Axatilimab and Corticosteroids as Initial Treatment for Chronic Graft-Versus-Host Disease
Chronic Graft-versus-host-disease
RecruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Richeldi, Prof,MD,PhD study director
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Riccardo Inchingolo, MD, PhD principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Pediatric Infectious Disorder, run by Catholic University of the Sacred Heart at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Riccardo Inchingolo, MD, PhD (+390630154236, riccardo.inchingolo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of uncomplicated CAP (time frame: 48 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03556488, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.