Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT02890797 |
| Other study ID # |
RC31/15/7858 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 12, 2018 |
| Est. completion date |
February 10, 2020 |
Study information
| Verified date |
December 2021 |
| Source |
University Hospital, Toulouse |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
900 to 1000 children are admitted each year for bronchiolitis in the pediatric emergency
department of the Toulouse Children Hospital. The diagnosis is based on clinical examination,
but in some cases furthers examinations such as chest X-ray are necessary in order to look
for a parenchymal condensation. Even if French recommendations do not place chest ultrasound
in the care pathway to date, many recent studies show the usefulness, rapidity and
reliability of ultrasound in parenchymal abnormalities. But regarding the bronchiolitis, few
studies are available and including limited numbers of patients. In addition, the reduction
of irradiation is a main goal, especially in children.
We propose to performed a chest ultrasound in infants (<24 months) admitted for bronchiolitis
with an available chest X-ray, in order to compare the performance of both examinations
(X-ray and ultrasound) for the diagnosis of parenchymal condensation. Besides, to correlate
initial chest ultrasound results and clinical evolution, parents will be contacted by phone 1
month after inclusion.
Primary outcome: The primary outcome is the sensitivity and specificity values of chest
ultrasound for the diagnosis of parenchymal condensations diagnosed by chest X-ray. Positive
and negative predictive values will also be estimated. This outcome is evaluated at the first
visit (T0).
Secondary outcomes:
- To describe chest X-ray and ultrasound abnormalities in bronchiolitis.
- To evaluate the performance of chest ultrasound to distinguish retractile and
non-retractile opacities complicating bronchiolitis.
- To study the correlation between clinical evolution at 1-month (malaise, place and
duration of hospitalization, re-hospitalization, oxygen therapy, antibiotic therapy) and
chest ultrasound results.
Follow-up parameters are recorded during a telephone call 1 month after inclusion.
Study design : It is a longitudinal, monocentric and prospective study with the aim to
evaluate a diagnostic examination.
