NCT02890797

Brief Summary

The diagnosis of bronchiolitis, the most frequent lung infectious disease in infancy, is based on clinical examination. Chest X-ray is proposed when a lung parenchymal condensation is suspected. Chest ultrasound is supposed to be a useful tool in the diagnosis of these complication but is poorly evaluated. We aim to compare chest X-ray and chest ultrasound for the diagnosis of parenchymal condensation in infant with bronchiolitis.

Trial Health

57
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Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
1.8 years until next milestone

Study Start

First participant enrolled

July 12, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2020

Completed
Last Updated

December 29, 2021

Status Verified

December 1, 2021

Enrollment Period

1.6 years

First QC Date

July 12, 2016

Last Update Submit

December 7, 2021

Conditions

Keywords

bronchiolitisparenchymal condensationchest X-raychest ultrasound

Outcome Measures

Primary Outcomes (1)

  • Presence of parenchymatous opacity

    Presence of parenchymatous opacity during thoracic radiological exam

    Inclusion

Secondary Outcomes (2)

  • Radiological anomaly

    Inclusion

  • Parenchymatous retractable (or non retractable) opacity

    Inclusion

Study Arms (1)

Bronchiolitis children

OTHER

Under two years old patient with bronchiolitis will have thoracic radiology

Radiation: radiology

Interventions

radiologyRADIATION

The investigators propose to performed a chest ultrasound in infants (\<24 months) admitted for bronchiolitis with an available chest X-ray

Bronchiolitis children

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Two years old patient at emergency Hospital (CHU-Toulouse) for bronchiolitis and performing of thoracic radiology
  • Informed consent formed to sign by family before the exam and the evidence of social security regime affiliation.

You may not qualify if:

  • Patient with cardiopulmonary disease or underlying immunosuppression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital des Enfants, Unité de pneumo-allergologie pédiatrique

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Bronchiolitis

Interventions

X-Rays

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic RadiationElectromagnetic PhenomenaMagnetic PhenomenaPhysical PhenomenaRadiationRadiation, Ionizing

Study Officials

  • Marine MICHELET, MD

    University Hospital, Toulouse

    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
SPONSOR

Study Record Dates

First Submitted

July 12, 2016

First Posted

September 7, 2016

Study Start

July 12, 2018

Primary Completion

February 10, 2020

Study Completion

February 10, 2020

Last Updated

December 29, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations