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Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children (LYMEPED)

C

Centre Hospitalier Universitaire de Besancon

Status

Unknown

Conditions

Lyme Disease

Treatments

Other: telephonic interview

Study type

Interventional

Funder types

Other

Identifiers

NCT03981874
P/2019/419

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Telephonic interview
Experimental group
Description:
Parents or patients will be contacted by phone in order to precise whether there are persistent sequelae or not
Treatment:
Other: telephonic interview

Trial contacts and locations

1

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Central trial contact

Candice Feuillebois, Int; Raphael Anxionnat, MD

Data sourced from clinicaltrials.gov

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