Clinical trial NCT02580812: Neurological Consequences of Perinatal Listeriosis Infection
Official title: Multicentric Observational National Analysis of Listeriosis and Listeria : Evaluation of the Neurological Consequences of Perinatal Listeriosis Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Listeriosis
Keywords: Perinatal listeriosis
Neurological impairment
Sepsis
Prematurity
Neurotropism
Listeria monocytogenes
Intellectual Quotient
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut Pasteur
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2015-10-20
Enrollment: 53
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of > 20 points of the Intellectual Quotient
timeFrame: Day 1
Secondary outcomes:
measure: Score obtained at M-ABC evaluation test (Movement-ABC)
timeFrame: Day 1
measure: Score obtained at SDQ evaluation test (Strenghts and Difficulties Questionnaire)
timeFrame: Day 1
measure: Score obtained at SCQ evaluation test (Social Communication Questionnaire)
timeFrame: Day 1
measure: Score obtained at BRIEF-P evaluation test (Behavior Rating Inventoring Executive Function)
timeFrame: Day 1
measure: Score obtained at HOME evaluation test (Home Observation and Measurement of Environment)
timeFrame: Day 1
measure: Score obtained at Vineland Scale
timeFrame: Day 1
measure: Scores obtained at NEPSY-2 evaluation tests
timeFrame: Day 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: 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
name: Caroline CHARLIER-WOERTHER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 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
name: Marc LECUIT, MD, PhD
role: STUDY_CHAIR
References: