Clinical Trial: Neurological Consequences of Perinatal Listeriosis Infection

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Assistance Publique - Hôpitaux de Paris

Current Primary Outcome: Reduction of > 20 points of the Intellectual Quotient [ Time Frame: Day 1 ]

Evaluated by standard tests (WPPSI-IV)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Score obtained at M-ABC evaluation test (Movement-ABC) [ Time Frame: Day 1 ]
    to evaluate alteration of executive functions
  • Score obtained at SDQ evaluation test (Strenghts and Difficulties Questionnaire) [ Time Frame: Day 1 ]
    to evaluate alteration of cognitive functions
  • Score obtained at SCQ evaluation test (Social Communication Questionnaire) [ Time Frame: Day 1 ]
    to evaluate alteration of cognitive functions
  • Score obtained at BRIEF-P evaluation test (Behavior Rating Inventoring Executive Function) [ Time Frame: Day 1 ]
    to evaluate alteration of executive functions
  • Score obtained at HOME evaluation test (Home Observation and Measurement of Environment) [ Time Frame: Day 1 ]
  • Score obtained at Vineland Scale [ Time Frame: Day 1 ]
  • Scores obtained at NEPSY-2 evaluation tests [ Time Frame: Day 1 ]


Original Secondary Outcome: Same as current

Information By: Assistance Publique - Hôpitaux de Paris

Dates:
Date Received: August 31, 2015
Date Started: October 2015
Date Completion: March 2019
Last Updated: July 31, 2016
Last Verified: July 2016