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| Name | Class |
|---|---|
| Institut Pasteur | INDUSTRY |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MONALISA 5-years old children | Experimental | Clinical and neuropsychological evaluation procedure 90 children |
|
| EPIPAGE 5 -years old children | Active Comparator | Cohort of prematurely borne children and their controls Clinical and neuropsychological evaluation procedure 270 children |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinical and neuropsychological evaluation procedure | Other | WPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of > 20 points of the Intellectual Quotient | Evaluated by standard tests (WPPSI-IV) | Day 1 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline CHARLIER-WOERTHER, MD, PhD | Service des Maladies Infectieuses et Tropicales, Centre d'Infectiologie Necker-Pasteur, IHU Imagine - Hôpital Necker-Enfants Malades, APHP / Centre National de Référence Listeria, Centre collaborateur OMS Listeria, Institut Pasteur | Principal Investigator |
| Marc LECUIT, MD, PhD | Service des Maladies Infectieuses et Tropicales, Centre d'Infectiologie Necker-Pasteur, IHU Imagine - Hôpital Necker-Enfants Malades, APHP /Centre National de Référence Listeria, Centre collaborateur OMS Listeria, institut Pasteur | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Necker-Enfants Malades | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37871603 | Result | Charlier C, Barrault Z, Rousseau J, Kermorvant-Duchemin E, Meyzer C, Semeraro M, Fall M, Coulpier G, Leclercq A, Charles MA, Ancel PY, Lecuit M. Long-term neurological and neurodevelopmental outcome of neonatal listeriosis in France: a prospective, matched, observational cohort study. Lancet Child Adolesc Health. 2023 Dec;7(12):875-885. doi: 10.1016/S2352-4642(23)00195-5. Epub 2023 Oct 20. |
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| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D018805 | Sepsis |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
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| 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 |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |