Back to resultsNeurological Consequences of Perinatal Listeriosis Infection (MONALISABABY)
Primary Purpose
Perinatal Listeriosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Clinical and neuropsychological evaluation procedure
Sponsored by
About this trial
This is an interventional diagnostic trial for Perinatal Listeriosis focused on measuring Perinatal listeriosis, Neurological impairment, Sepsis, Prematurity, Neurotropism, Listeria monocytogenes, Intellectual Quotient
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
Sites / Locations
- Hôpital Necker-Enfants Malades
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MONALISA 5-years old children
EPIPAGE 5 -years old children
Arm Description
Clinical and neuropsychological evaluation procedure 90 children
Cohort of prematurely borne children and their controls Clinical and neuropsychological evaluation procedure 270 children
Outcomes
Primary Outcome Measures
Reduction of > 20 points of the Intellectual Quotient
Evaluated by standard tests (WPPSI-IV)
Secondary Outcome Measures
Score obtained at M-ABC evaluation test (Movement-ABC)
to evaluate alteration of executive functions
Score obtained at SDQ evaluation test (Strenghts and Difficulties Questionnaire)
to evaluate alteration of cognitive functions
Score obtained at SCQ evaluation test (Social Communication Questionnaire)
to evaluate alteration of cognitive functions
Score obtained at BRIEF-P evaluation test (Behavior Rating Inventoring Executive Function)
to evaluate alteration of executive functions
Score obtained at HOME evaluation test (Home Observation and Measurement of Environment)
Score obtained at Vineland Scale
Scores obtained at NEPSY-2 evaluation tests
Full Information
NCT ID
NCT02580812
First Posted
August 31, 2015
Last Updated
March 31, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut Pasteur, Institut National de la Santé Et de la Recherche Médicale, France
1. Study Identification
Unique Protocol Identification Number
NCT02580812
Brief Title
Neurological Consequences of Perinatal Listeriosis Infection
Acronym
MONALISABABY
Official Title
Multicentric Observational National Analysis of Listeriosis and Listeria : Evaluation of the Neurological Consequences of Perinatal Listeriosis Infection
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 26, 2015 (Actual)
Primary Completion Date
October 29, 2018 (Actual)
Study Completion Date
October 29, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut Pasteur, Institut National de la Santé Et de la Recherche Médicale, France
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perinatal Listeriosis
Keywords
Perinatal listeriosis, Neurological impairment, Sepsis, Prematurity, Neurotropism, Listeria monocytogenes, Intellectual Quotient
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MONALISA 5-years old children
Arm Type
Experimental
Arm Description
Clinical and neuropsychological evaluation procedure 90 children
Arm Title
EPIPAGE 5 -years old children
Arm Type
Active Comparator
Arm Description
Cohort of prematurely borne children and their controls Clinical and neuropsychological evaluation procedure 270 children
Intervention Type
Other
Intervention Name(s)
Clinical and neuropsychological evaluation procedure
Intervention Description
WPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination
Primary Outcome Measure Information:
Title
Reduction of > 20 points of the Intellectual Quotient
Description
Evaluated by standard tests (WPPSI-IV)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Score obtained at M-ABC evaluation test (Movement-ABC)
Description
to evaluate alteration of executive functions
Time Frame
Day 1
Title
Score obtained at SDQ evaluation test (Strenghts and Difficulties Questionnaire)
Description
to evaluate alteration of cognitive functions
Time Frame
Day 1
Title
Score obtained at SCQ evaluation test (Social Communication Questionnaire)
Description
to evaluate alteration of cognitive functions
Time Frame
Day 1
Title
Score obtained at BRIEF-P evaluation test (Behavior Rating Inventoring Executive Function)
Description
to evaluate alteration of executive functions
Time Frame
Day 1
Title
Score obtained at HOME evaluation test (Home Observation and Measurement of Environment)
Time Frame
Day 1
Title
Score obtained at Vineland Scale
Time Frame
Day 1
Title
Scores obtained at NEPSY-2 evaluation tests
Time Frame
Day 1
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline CHARLIER-WOERTHER, MD, PhD
Organizational 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
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc LECUIT, MD, PhD
Organizational 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
Official's Role
Study Chair
Facility Information:
Facility Name
Hôpital Necker-Enfants Malades
City
Paris
ZIP/Postal Code
75015
Country
France
12. IPD Sharing Statement
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Neurological Consequences of Perinatal Listeriosis Infection
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