Perinatal Listeriosis
Conditions
Keywords
Perinatal listeriosis, Neurological impairment, Sepsis, Prematurity, Neurotropism, Listeria monocytogenes, Intellectual Quotient
Brief summary
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
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.
Interventions
OTHERClinical and neuropsychological evaluation procedure
WPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination
Sponsors
Institut Pasteur
Institut National de la Santé Et de la Recherche Médicale, France
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of > 20 points of the Intellectual Quotient | Day 1 | Evaluated by standard tests (WPPSI-IV) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score obtained at SDQ evaluation test (Strenghts and Difficulties Questionnaire) | Day 1 | to evaluate alteration of cognitive functions |
| Score obtained at SCQ evaluation test (Social Communication Questionnaire) | Day 1 | to evaluate alteration of cognitive functions |
| Score obtained at BRIEF-P evaluation test (Behavior Rating Inventoring Executive Function) | Day 1 | to evaluate alteration of executive functions |
| Score obtained at M-ABC evaluation test (Movement-ABC) | Day 1 | to evaluate alteration of executive functions |
| Score obtained at Vineland Scale | Day 1 | — |
| Scores obtained at NEPSY-2 evaluation tests | Day 1 | — |
| Score obtained at HOME evaluation test (Home Observation and Measurement of Environment) | Day 1 | — |
Countries
France
Outcome results
None listed