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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03981874
Other study ID # P/2019/419
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 29, 2019
Est. completion date July 29, 2019

Study information

Verified date June 2019
Source Centre Hospitalier Universitaire de Besancon
Contact Candice Feuillebois, Int
Phone +33381218516
Email sydnak@hotmail.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Neuroborreliosis (NB) is the second most frequent manifestation of Lyme disease. Painful meningoradiculitis is the most common neurologic manifestation in adults while facial nerve palsy (FP) and lymphocytic meningitis is predominant in children. FP is a common reason for pediatric consultation and FP due to Lyme borreliosis (LB) represents about 50% of the child's FP in an endemic area.

The action to be taken is not formally defined for a child consulting for FP in a Lyme disease endemic area.

The new recommendations of the High Authority of Health of June 2018 recommend to carry out a blood serology in first intention, in search of a NB in a child consulting for a peripheral facial paralysis. If this is positive, a lumbar puncture will be performed in search of meningitis. In the case of negative serology, a close clinical surveillance and sometimes serological control is necessary, in order to reassess the diagnosis. In adult recommendations, a lumbar puncture is performed first in any patient consulting for facial paralysis in LB endemic area.

The main objective of this study was to describe the clinical and biological characteristics of pediatric NB with FP. Others objectives were to describe the diagnostic and therapeutic behavior of a child consulting at university hospital for a facial nerve palsy, to compare the initial gravity of facial nerve palsy, the duration of the paralysis and sequels depending on the diagnosis and treatment initiated.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 29, 2019
Est. primary completion date July 29, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- Children consulting for peripheral facial palsy

Exclusion Criteria:

- Children consulting for central facial palsy

- Children with congenital peripheral facial palsy

- Children with surgery and trauma in the area of the facial nerve,

- Children with peripheral facial palsy with previous diagnosis

- Children whose parents refuse the study participation

Study Design


Related Conditions & MeSH terms


Intervention

Other:
telephonic interview
Telephonic interview

Locations

Country Name City State
France CHU Besancon Besançon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assesment of persistent sequelae Facial paralysis duration assesment and persistence of physical sequelae at time of the telephonic call using House & Brackmann classification for facial function.
This grading system has 6 levels, used for middle- to long-term monitoring:
I. Normal II. Mild dysfunction III. Moderate dysfunction IV. Moderately severe dysfunction
4 years
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