Lung Ultrasound in Diagnosing and Monitoring of Pulmonary Complications in Children With Acute Bronchiolitis

Use of Lung Ultrasound in Children With Acute Bronchiolitis



Sponsors


Source

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Oversight Info

Is Fda Regulated Drug

No

Is Fda Regulated Device

No


Brief Summary

Bronchiolitis is the leading cause of hospitalization in infants. The diagnosis is clinical
and chest x-ray (CXR) should be reserved for severe cases in which signs of pulmonary
complications are present. Nevertheless, CXR is performed in more than 50% of hospitalized
patients with bronchiolitis, which exposes infants to ionizing radiation.

Data on the possible role of lung ultrasound (LUS) in children with bronchiolitis and
suspected pulmonary complications have not been published yet.

The purpose of this study is to evaluate the use of LUS compared to CXR in diagnosing and
monitoring pulmonary complications (pneumonia, pleural effusion, pneumothorax) in children
with acute bronchiolitis. The second purpose of the study is to evaluate the correlation
between clinical course and ultrasound findings in children with bronchiolitis.

The inclusion of LUS in the diagnostic work-up of bronchiolitis could possibly reduce the
misuse of CXR in infants and the exposure to ionizing radiations.

Detailed Description

Bronchiolitis is the most common lower respiratory tract infection that affects children
younger than 24 months. The diagnosis is clinical and, according to international guidelines,
chest x-ray (CXR) should be reserved for cases in which signs of pulmonary complications are
present or where respiratory effort is severe to warrant intensive care unit admission.
Despite these recommendations, CXR is still performed in about 50% of bronchiolitis (ranging
from 24 to 77%), which exposes infants to ionizing radiation.

Given its portability, no ionizing radiation, rapid and repeat testing, lung ultrasound (LUS)
has become an emerging diagnostic tool for pneumonia, pleural effusion and pneumothorax in
adults and children. At present, LUS is not included in the diagnostic work-up of
bronchiolitis. Previous papers have reported that LUS may be useful in bronchiolitis because
of a good correlation between clinical course and ultrasound findings. However, data on the
possible role of LUS in children with bronchiolitis and suspected pulmonary complications
have not been published yet.

Enrolled patients will undergo a bedside LUS in the first 12 hours after CXR. LUS will be
performed by one paediatrician with specific LUS expertise and blinded to clinical and
radiological data. The paediatrician must have previously attended a specific course on LUS
and supervised practical training. A Mindray-DC-T6 ultrasound machine equipped with a linear
probe with frequencies ranging from 7.5 to 12 MHz will be use. LUS examination will consist
of both longitudinal and transversal sections from the anterior, lateral and posterior chest
wall according to the methodology described by Copetti et al. A radiologist will then
independently repeat the LUS to test the sonographer inter-observer agreement. The
radiologist will be blinded to the results of the previous studies (LUS and CXR). The LUS
findings will be recorded on the data form together with patient demographics, symptoms, CXR
findings and laboratory data.

Patients with LUS positive for pulmonary complications will receive follow-up ultrasound
every 48 hours until the resolution or the discharge.

Overall Status

Recruiting

Start Date

2016-02-01

Completion Date

2018-09-01

Primary Completion Date

2017-10-01

Phase

N/A

Study Type

Interventional

Primary Outcome

Measure

Time Frame

LUS vs CXR in diagnosing pulmonary complications in bronchiolitis
12 hours

Secondary Outcome

Measure

Time Frame

Sonographer inter-observer agreement
12 hours
LUS and severity of bronchiolitis
12 hours

Enrollment

150

Condition


Intervention

Intervention Type

Device

Intervention Name


Description

A Mindray-DC-T6 ultrasound machine equipped with a linear probe with frequencies ranging from 7.5 to 12 MHz will be use. LUS examination will consist of both longitudinal and transversal sections according to the methodology described by Copetti and colleagues.

Arm Group Label

Lung Ultrasound


Eligibility

Criteria

Inclusion Criteria:

- Children hospitalized with a diagnosis of bronchiolitis

- Age < 24 months

- CXR as part of usual clinical practice because of clinical suspicion of pulmonary
complications

- Informed written consent

Exclusion Criteria:

- chronic respiratory disease (i.e. bronchopulmonary dysplasia)

- congenital heart disease

- severe neuromuscular disease

- congenital or acquired immunodeficiency

Gender

All

Minimum Age

N/A

Maximum Age

24 Months

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Marcello Lanari, Professor
Principal Investigator
Pediatric Emergency Unit, S. Orsola-Malpighi Hospital, University of Bologna

Overall Contact

Last Name

Carlotta Biagi, MD

Email



Location

Facility

Status

Contact

Pediatric Emergency Unit, S. Orsola-Malpighi Hospital
Bologna BO 40138 Italy
Recruiting
Last Name: Carlotta Biagi, MD
Email: [email protected]

Location Countries

Country

Italy


Verification Date

2017-09-01

Lastchanged Date

2017-09-10

Firstreceived Date

2017-09-10

Responsible Party

Responsible Party Type

Principal Investigator

Investigator Affiliation

Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Investigator Full Name

Marcello Lanari

Investigator Title

Director, Professor


Keywords


Has Expanded Access

No

Condition Browse


Number Of Arms

1

Arm Group

Arm Group Label

Lung Ultrasound

Arm Group Type

Experimental

Description

Bedside lung ultrasound will be performed by a paediatrician with specific LUS expertise and blinded to clinical and radiological data.


Firstreceived Results Date

N/A

Reference

Citation

Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742. Erratum in: Pediatrics. 2015 Oct;136(4):782.

PMID

25349312


Citation

Parikh K, Hall M, Mittal V, Montalbano A, Mussman GM, Morse RB, Hain P, Wilson KM, Shah SS. Establishing benchmarks for the hospitalized care of children with asthma, bronchiolitis, and pneumonia. Pediatrics. 2014 Sep;134(3):555-62. doi: 10.1542/peds.2014-1052.

PMID

25136044


Citation

Florin TA, Byczkowski T, Ruddy RM, Zorc JJ, Test M, Shah SS. Variation in the management of infants hospitalized for bronchiolitis persists after the 2006 American Academy of Pediatrics bronchiolitis guidelines. J Pediatr. 2014 Oct;165(4):786-92.e1. doi: 10.1016/j.jpeds.2014.05.057. Epub 2014 Jul 9.

PMID

25015578


Citation

Mazrani W, McHugh K, Marsden PJ. The radiation burden of radiological investigations. Arch Dis Child. 2007 Dec;92(12):1127-31. Review.

PMID

18032642


Citation

Copetti R, Cattarossi L. Ultrasound diagnosis of pneumonia in children. Radiol Med. 2008 Mar;113(2):190-8. doi: 10.1007/s11547-008-0247-8. Epub 2008 Apr 2. English, Italian.

PMID

18386121



Firstreceived Results Disposition Date

N/A

Study Design Info

Intervention Model

Single Group Assignment

Primary Purpose

Diagnostic

Masking

None (Open Label)



ClinicalTrials.gov processed this data on September 12, 2017

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

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