Neurological Consequences of Perinatal Listeriosis Infection (MONALISABABY)

Multicentric Observational National Analysis of Listeriosis and Listeria : Evaluation of the Neurological Consequences of Perinatal Listeriosis Infection

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.

Study Overview

• Status: Completed
• Conditions: Perinatal Listeriosis
• Intervention / Treatment: Other: Clinical and neuropsychological evaluation procedure

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 Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75015
    • Hôpital Necker-Enfants Malades

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MONALISA 5-years old children; Clinical and neuropsychological evaluation procedure 90 children	Other: Clinical and neuropsychological evaluation procedure; WPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination
Active Comparator: EPIPAGE 5 -years old children; Cohort of prematurely borne children and their controls Clinical and neuropsychological evaluation procedure 270 children	Other: Clinical and neuropsychological evaluation procedure; WPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of > 20 points of the Intellectual Quotient	Evaluated by standard tests (WPPSI-IV)	Day 1

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Institut Pasteur
• Investigators: Principal Investigator: 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; Study Chair: 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 record dates

Study Major Dates

• Study Start (Actual): October 26, 2015
• Primary Completion (Actual): October 29, 2018
• Study Completion (Actual): October 29, 2018

Study Registration Dates

• First Submitted: August 31, 2015
• First Submitted That Met QC Criteria: October 18, 2015
• First Posted (Estimate): October 20, 2015

Study Record Updates

• Last Update Posted (Actual): April 5, 2021
• Last Update Submitted That Met QC Criteria: March 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Sepsis; Prematurity; Listeria monocytogenes; Neurotropism; Perinatal listeriosis; Neurological impairment; Intellectual Quotient
• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Listeriosis
• Other Study ID Numbers: P140940