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Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children (LYMEPED)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lyme Disease | Other: telephonic interview | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 50 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Diagnostic |
| Official Title: | Comparative Study of Peripheral Facial Paralysis Sequelae Based on the Initial Medical Care of Lyme Disease Among Children |
| Actual Study Start Date : | May 29, 2019 |
| Estimated Primary Completion Date : | July 29, 2019 |
| Estimated Study Completion Date : | July 29, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Telephonic interview
Parents or patients will be contacted by phone in order to precise whether there are persistent sequelae or not
|
Other: telephonic interview
Telephonic interview
|
- Assesment of persistent sequelae [ Time Frame: 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
| Ages Eligible for Study: | up to 18 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
| Contact: Candice Feuillebois, Int | +33381218516 | sydnak@hotmail.fr | |
| Contact: Raphael Anxionnat, MD | +33381218516 | ranxionnat@chu-besancon.fr |
| France | |
| CHU Besancon | Recruiting |
| Besançon, France | |
| Principal Investigator: | Raphael Anxionnat, MD | CHU Besançon |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 7, 2019 | ||||
| First Posted Date ICMJE | June 11, 2019 | ||||
| Last Update Posted Date | June 12, 2019 | ||||
| Actual Study Start Date ICMJE | May 29, 2019 | ||||
| Estimated Primary Completion Date | July 29, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Assesment of persistent sequelae [ Time Frame: 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
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Peripheral Facial Paralysis Sequelae in Lyme Disease Among Children | ||||
| Official Title ICMJE | Comparative Study of Peripheral Facial Paralysis Sequelae Based on the Initial Medical Care of Lyme Disease Among Children | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Diagnostic |
||||
| Condition ICMJE | Lyme Disease | ||||
| Intervention ICMJE | Other: telephonic interview
Telephonic interview
|
||||
| Study Arms ICMJE | Experimental: Telephonic interview
Parents or patients will be contacted by phone in order to precise whether there are persistent sequelae or not
Intervention: Other: telephonic interview
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Unknown status | ||||
| Estimated Enrollment ICMJE |
50 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | July 29, 2019 | ||||
| Estimated Primary Completion Date | July 29, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | up to 18 Years (Child, Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03981874 | ||||
| Other Study ID Numbers ICMJE | P/2019/419 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE |
|
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| Responsible Party | Centre Hospitalier Universitaire de Besancon | ||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Besancon | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
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| PRS Account | Centre Hospitalier Universitaire de Besancon | ||||
| Verification Date | June 2019 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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