Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children

Not Applicable

• Conditions: Lyme Disease
• Interventions: Other: telephonic interview

• Registration Number: NCT03981874
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-29
• Status Verified: 2019-06
• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-10
• Study First Posted: 2019-06-11
• Last Update Submitted: 2019-06-11
• Last Update Posted: 2019-06-12
• Primary Completion: 2019-07-29
• Study Completion: 2019-07-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telephonic interview	telephonic interview	Parents or patients will be contacted by phone in order to precise whether there are persistent sequelae or not

Primary Outcome Measures

Name	Time	Method
Assesment of persistent sequelae	4 years	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

Trial Locations

Locations (1)

CHU Besancon; 🇫🇷 Besançon, France