Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children (LYMEPED)
Primary Purpose
Lyme Disease
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
telephonic interview
Sponsored by
About this trial
This is an interventional diagnostic trial for Lyme Disease focused on measuring neuroborreliosis, facial palsy, children
Eligibility Criteria
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
Sites / Locations
- CHU BesanconRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Telephonic interview
Arm Description
Parents or patients will be contacted by phone in order to precise whether there are persistent sequelae or not
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03981874
First Posted
June 7, 2019
Last Updated
June 11, 2019
Sponsor
Centre Hospitalier Universitaire de Besancon
1. Study Identification
Unique Protocol Identification Number
NCT03981874
Brief Title
Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children
Acronym
LYMEPED
Official Title
Comparative Study of Peripheral Facial Paralysis Sequelae Based on the Initial Medical Care of Lyme Disease Among Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 29, 2019 (Actual)
Primary Completion Date
July 29, 2019 (Anticipated)
Study Completion Date
July 29, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lyme Disease
Keywords
neuroborreliosis, facial palsy, children
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Telephonic interview
Arm Type
Experimental
Arm Description
Parents or patients will be contacted by phone in order to precise whether there are persistent sequelae or not
Intervention Type
Other
Intervention Name(s)
telephonic interview
Intervention Description
Telephonic interview
Primary Outcome Measure Information:
Title
Assesment of persistent sequelae
Description
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
Time Frame
4 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Candice Feuillebois, Int
Phone
+33381218516
Email
sydnak@hotmail.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Raphael Anxionnat, MD
Phone
+33381218516
Email
ranxionnat@chu-besancon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raphael Anxionnat, MD
Organizational Affiliation
CHU Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besancon
City
Besançon
Country
France
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children
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