Neurological Consequences of Perinatal Listeriosis Infection (MONALISABABY)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Perinatal Listeriosis

Treatments: Other: Clinical and neuropsychological evaluation procedure

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02580812

P140940

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 5 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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53 participants in 2 patient groups

MONALISA 5-years old children

Experimental group

Description:

Clinical and neuropsychological evaluation procedure 90 children

Treatment:

Other: Clinical and neuropsychological evaluation procedure

EPIPAGE 5 -years old children

Active Comparator group

Description:

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

Treatment:

Other: Clinical and neuropsychological evaluation procedure