Use of Lung Ultrasound in Children With Acute Bronchiolitis

NCT03280732 | Completed

• 1 other identifier: 13/2016/O/Sper
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis Acute

Keywords

Lung Ultrasound; Chest X-Ray; Pneumonia; Pneumothorax; Pleural effusion

Outcome Measures

Primary Outcomes (1)

• LUS vs CXR in diagnosing pulmonary complications in bronchiolitis

  To evaluate the use of LUS compared to CXR to diagnose pulmonary complications (pneumonia, pleural effusion, pneumothorax) in children with acute bronchiolitis

  12 hours

Secondary Outcomes (2)

• Sonographer inter-observer agreement

  12 hours

• LUS and severity of bronchiolitis

  12 hours

Study Arms (1)

Lung Ultrasound

EXPERIMENTAL

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

Device: Lung Ultrasound

Interventions

Lung Ultrasound DEVICE

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.

Lung Ultrasound

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• chronic respiratory disease (i.e. bronchopulmonary dysplasia)
• congenital heart disease
• severe neuromuscular disease
• congenital or acquired immunodeficiency

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Pediatric Emergency Unit, S. Orsola-Malpighi Hospital

Bologna, BO, 40138, Italy

Location

Related Publications (6)

• 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.

  PMID: 25349312 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Mazrani W, McHugh K, Marsden PJ. The radiation burden of radiological investigations. Arch Dis Child. 2007 Dec;92(12):1127-31. doi: 10.1136/adc.2006.101782.

  PMID: 18032642 BACKGROUND

• 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 BACKGROUND

• Biagi C, Pierantoni L, Baldazzi M, Greco L, Dormi A, Dondi A, Faldella G, Lanari M. Lung ultrasound for the diagnosis of pneumonia in children with acute bronchiolitis. BMC Pulm Med. 2018 Dec 7;18(1):191. doi: 10.1186/s12890-018-0750-1.

  PMID: 30526548 DERIVED

MeSH Terms

Conditions

Pneumonia; Pneumothorax; Pleural Effusion

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Pleural Diseases

Study Officials

• Marcello Lanari, Professor

  Pediatric Emergency Unit, S. Orsola-Malpighi Hospital, University of Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Professor

Study Record Dates

• First Submitted: September 10, 2017
• First Posted: September 12, 2017
• Study Start: February 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: December 1, 2018
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)