Neurological Consequences of Perinatal Listeriosis Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-26

Study Completion Date

2018-10-29

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.

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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.

Conditions

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Perinatal Listeriosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MONALISA 5-years old children

Clinical and neuropsychological evaluation procedure 90 children

Group Type EXPERIMENTAL

Clinical and neuropsychological evaluation procedure

Intervention Type OTHER

WPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination

EPIPAGE 5 -years old children

Cohort of prematurely borne children and their controls Clinical and neuropsychological evaluation procedure 270 children

Group Type ACTIVE_COMPARATOR

Clinical and neuropsychological evaluation procedure

Intervention Type OTHER

WPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination

Interventions

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Clinical and neuropsychological evaluation procedure

WPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination

Intervention Type OTHER

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

Minimum Eligible Age

5 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline CHARLIER-WOERTHER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Marc LECUIT, MD, PhD

Role: STUDY_CHAIR

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