Neurological Consequences of Perinatal Listeriosis Infection

Study Overview
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Brief Summary
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The purpose of the study is to determine whether perinatal listeriosis is associated with long-term neurological consequences, and to evaluate the respective contribution of perinatal sepsis, of prematurity and of the known neurological tropism of the involved pathogen, Listeria monocytogenes.

Detailed Description
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Perinatal listeriosis is defined by the occurrence of maternal listeriosis at birth and/or of early-onset listeriosis in the neonate (defined by the positive culture of any sample of maternal or neonatal origin). Neurological involvement is defined by the presence of inflammation of the cerebrospinal fluid of positive culture or the cerebro-spinal fluid. Evaluation is performed at the age of 5 years, and includes WPPSI evaluation of the Intelligence Quotient (IQ), NEPSY evaluation of the executive functions and clinical evaluation checking for any motor, sensorial or other focal deficiency among 90 cases and 270 controls matched for gestational age.

Official Title
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Multicentric Observational National Analysis of Listeriosis and Listeria : Evaluation of the Neurological Consequences of Perinatal Listeriosis Infection

Conditions
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Perinatal Listeriosis

Intervention / Treatment
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* Other: Clinical and neuropsychological evaluation procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children from the MONALISA cohort (culture proven-maternal listeriosis) Or Children from the EPIPAGE cohort (control group) Written consent from the parent(s) or legal representative Exclusion Criteria: Children whose parents or legal representative would deny their consent

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MONALISA 5-years old children<br>Clinical and neuropsychological evaluation procedure 90 children | Other: Clinical and neuropsychological evaluation procedure<br>* WPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination<br>|
| Active Comparator: EPIPAGE 5 -years old children<br>Cohort of prematurely borne children and their controls Clinical and neuropsychological evaluation procedure 270 children | Other: Clinical and neuropsychological evaluation procedure<br>* WPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of > 20 points of the Intellectual Quotient | Evaluated by standard tests (WPPSI-IV) | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score obtained at M-ABC evaluation test (Movement-ABC) | to evaluate alteration of executive functions | Day 1 | 
| Score obtained at SDQ evaluation test (Strenghts and Difficulties Questionnaire) | to evaluate alteration of cognitive functions | Day 1 | 
| Score obtained at SCQ evaluation test (Social Communication Questionnaire) | to evaluate alteration of cognitive functions | Day 1 | 
| Score obtained at BRIEF-P evaluation test (Behavior Rating Inventoring Executive Function) | to evaluate alteration of executive functions | Day 1 | 
| Score obtained at HOME evaluation test (Home Observation and Measurement of Environment) |  | Day 1 | 
| Score obtained at Vineland Scale |  | Day 1 | 
| Scores obtained at NEPSY-2 evaluation tests |  | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perinatal listeriosis, Neurological impairment, Sepsis, Prematurity, Neurotropism, Listeria monocytogenes, Intellectual Quotient