Neurological Consequences of Perinatal Listeriosis Infection

Not Applicable

Completed

• Conditions: Perinatal Listeriosis
• Interventions: Other: Clinical and neuropsychological evaluation procedure

• Registration Number: NCT02580812
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-10-18
• Study First Posted: 2015-10-20
• Study Start: 2015-10-26
• Primary Completion: 2018-10-29
• Study Completion: 2018-10-29
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-31
• Last Update Posted: 2021-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MONALISA 5-years old children	Clinical and neuropsychological evaluation procedure	Clinical and neuropsychological evaluation procedure 90 children
EPIPAGE 5 -years old children	Clinical and neuropsychological evaluation procedure	Cohort of prematurely borne children and their controls Clinical and neuropsychological evaluation procedure 270 children

Primary Outcome Measures

Name	Time	Method
Reduction of > 20 points of the Intellectual Quotient	Day 1	Evaluated by standard tests (WPPSI-IV)

Secondary Outcome Measures

Name	Time	Method
Score obtained at BRIEF-P evaluation test (Behavior Rating Inventoring Executive Function)	Day 1	to evaluate alteration of executive functions
Score obtained at HOME evaluation test (Home Observation and Measurement of Environment)	Day 1
Scores obtained at NEPSY-2 evaluation tests	Day 1
Score obtained at M-ABC evaluation test (Movement-ABC)	Day 1	to evaluate alteration of executive functions
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 Vineland Scale	Day 1

Trial Locations

Locations (1)

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France