NCT01993797

Brief Summary

To evaluate the correlation between clinical and ultrasound findings in children presented with signs suggestive of bronchiolitis and to validate an ultrasound score for bronchiolitis that will correlate with specific clinical outcomes.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2010

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

December 13, 2013

Status Verified

December 1, 2013

Enrollment Period

3.9 years

First QC Date

November 19, 2013

Last Update Submit

December 12, 2013

Conditions

Bronchiolitis

Keywords

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

  • clinical and ultrasound findings

    To evaluate the correlation between clinical and ultrasound findings in children presented with signs suggestive of bronchiolitis

    baseline

Secondary Outcomes (1)

  • ultrasound score for bronchiolitis and clinical outcome

    baseline

Study Arms (1)

Bronchiolitis

children presented with signs suggestive of bronchiolitis

Other: Lung US

Interventions

Lung USOTHER
Bronchiolitis

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children presented with signs suggestive of bronchiolitis

You may qualify if:

  • children presented with signs suggestive of bronchiolitis

You may not qualify if:

  • other major pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S Giacomo Hospital

Monopoli, Bari, Italy

Location

Related Publications (2)

  • 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

  • Basile V, Di Mauro A, Scalini E, Comes P, Lofu I, Mostert M, Tafuri S, Manzionna MM. Lung ultrasound: a useful tool in diagnosis and management of bronchiolitis. BMC Pediatr. 2015 May 21;15:63. doi: 10.1186/s12887-015-0380-1.

    PMID: 25993984DERIVED

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Pediatric Unit

Study Record Dates

First Submitted

November 19, 2013

First Posted

November 25, 2013

Study Start

January 1, 2010

Primary Completion

December 1, 2013

Last Updated

December 13, 2013

Record last verified: 2013-12

Locations

IT(1)