NCT01452945

Brief Summary

Young children presenting to the Emergency Department (ED) with wheezing often have prolonged stays in the ED or even get admitted to the hospital. This is a prospective observational study in which the investigators will use bedside 2D ultrasound to evaluate the lung ultrasound findings in children less than 24 months presenting to the ED with wheezing. The investigators hypothesize that children less than 24 months presenting to the Emergency Department with wheezing will have a range of lung ultrasound findings that will include normal findings, B lines, subpleural consolidations, and pleural effusions. The investigators also hypothesize that the findings will be reproducible between two equally trained providers. The investigators also hypothesize that lung ultrasound findings patients 0-24 months presenting to the ED with wheezing will correlate with specific clinical outcomes. An exploratory analysis will be performed to look for correlations between lung US findings and acute severity, final diagnosis, presenting symptoms, prematurity, risk factors for atopy, response to treatment and radiologic or viral studies if performed.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2011

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

May 21, 2015

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

October 13, 2011

Last Update Submit

May 19, 2015

Conditions

Eligibility Criteria

AgeUp to 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children 0-24 months presenting to a pediatric Emergency Department with wheezing

You may qualify if:

  • Age less than or equal to 24 months
  • Presenting to the pediatric ED with wheezing

You may not qualify if:

  • On home oxygen at baseline
  • Cyanotic congenital cardiac disease (including: ToF, TAPVR, HLHS, d-TGA, TA, pulm atresia, critical pulm stenosis, but not including VSD, ASD, Coarctation of the Aorta)
  • Endotracheal tube or tracheostomy in place and/or receiving mechanical ventilation
  • Transferred from an outside hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Medical Center Division of Emergency Medicine

Washington D.C., District of Columbia, 10010, United States

Location

Related Publications (4)

  • Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.

    PMID: 16984837BACKGROUND
  • Lichtenstein D, Meziere G, Biderman P, Gepner A, Barre O. The comet-tail artifact. An ultrasound sign of alveolar-interstitial syndrome. Am J Respir Crit Care Med. 1997 Nov;156(5):1640-6. doi: 10.1164/ajrccm.156.5.96-07096.

    PMID: 9372688BACKGROUND
  • Copetti R, Cattarossi L, Macagno F, Violino M, Furlan R. Lung ultrasound in respiratory distress syndrome: a useful tool for early diagnosis. Neonatology. 2008;94(1):52-9. doi: 10.1159/000113059. Epub 2008 Jan 15.

    PMID: 18196931BACKGROUND
  • Caiulo VA, Gargani L, Caiulo S, Fisicaro A, Moramarco F, Latini G, Picano E. Lung ultrasound in bronchiolitis: comparison with chest X-ray. Eur J Pediatr. 2011 Nov;170(11):1427-33. doi: 10.1007/s00431-011-1461-2. Epub 2011 Apr 6.

    PMID: 21468639BACKGROUND

MeSH Terms

Conditions

Respiratory SoundsBronchiolitis

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Joanna S Cohen, MD

    Children's National Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics and Emergency Medicine

Study Record Dates

First Submitted

October 13, 2011

First Posted

October 17, 2011

Study Start

October 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

May 21, 2015

Record last verified: 2015-05

Locations