Neurological Consequences of Perinatal Listeriosis Infection

Perinatal Listeriosis Clinical Trial

— MONALISABABY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02580812
• Other study ID #: P140940
• Status: Completed
• Phase: N/A
• Start date: October 26, 2015
• Est. completion date: October 29, 2018

Study information

• Verified date: March 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 29, 2018
• Est. primary completion date: October 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Listeriosis
• Perinatal Listeriosis

Intervention

Other:
• Clinical and neuropsychological evaluation procedure
WPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination

Locations

Country	Name	City	State
France	Hôpital Necker-Enfants Malades	Paris

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France, Institut Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of > 20 points of the Intellectual Quotient	Evaluated by standard tests (WPPSI-IV)	Day 1
Secondary	Score obtained at M-ABC evaluation test (Movement-ABC)	to evaluate alteration of executive functions	Day 1
Secondary	Score obtained at SDQ evaluation test (Strenghts and Difficulties Questionnaire)	to evaluate alteration of cognitive functions	Day 1
Secondary	Score obtained at SCQ evaluation test (Social Communication Questionnaire)	to evaluate alteration of cognitive functions	Day 1
Secondary	Score obtained at BRIEF-P evaluation test (Behavior Rating Inventoring Executive Function)	to evaluate alteration of executive functions	Day 1
Secondary	Score obtained at HOME evaluation test (Home Observation and Measurement of Environment)		Day 1
Secondary	Score obtained at Vineland Scale		Day 1
Secondary	Scores obtained at NEPSY-2 evaluation tests		Day 1