Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children

NCT ID: NCT03981874

Last Updated: 2019-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-29

Study Completion Date

2019-07-29

Brief Summary

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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

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Conditions

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Lyme Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Telephonic interview

Parents or patients will be contacted by phone in order to precise whether there are persistent sequelae or not

Group Type EXPERIMENTAL

telephonic interview

Intervention Type OTHER

Telephonic interview

Interventions

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telephonic interview

Telephonic interview

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raphael Anxionnat, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Besançon

Locations

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CHU Besancon

Besançon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Candice Feuillebois, Int

Role: CONTACT

+33381218516

Raphael Anxionnat, MD

Role: CONTACT

+33381218516

Other Identifiers

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P/2019/419

Identifier Type: -

Identifier Source: org_study_id

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