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Completed

NCT Number: NCT02580812

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.

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Key information

Conditions

Perinatal Listeriosis Female Urogenital Diseases and Pregnancy Complications Infections Inflammation Nervous System Diseases Neurologic Manifestations Obstetric Labor Complications Obstetric Labor, Premature Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Sepsis Signs and Symptoms Systemic Inflammatory Response Syndrome Urogenital Diseases

Age range

5 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Necker-Enfants Malades

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Clinical and neuropsychological evaluation procedure

Other

WPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination

Primary outcomes

  1. Reduction of > 20 points of the Intellectual Quotient

    Time frame: Day 1

    Evaluated by standard tests (WPPSI-IV)

Secondary outcomes

  1. Score obtained at M-ABC evaluation test (Movement-ABC)

    Time frame: Day 1

    to evaluate alteration of executive functions

  2. Score obtained at SDQ evaluation test (Strenghts and Difficulties Questionnaire)

    Time frame: Day 1

    to evaluate alteration of cognitive functions

  3. Score obtained at SCQ evaluation test (Social Communication Questionnaire)

    Time frame: Day 1

    to evaluate alteration of cognitive functions

  4. Score obtained at BRIEF-P evaluation test (Behavior Rating Inventoring Executive Function)

    Time frame: Day 1

    to evaluate alteration of executive functions

  5. Score obtained at HOME evaluation test (Home Observation and Measurement of Environment)

    Time frame: Day 1

  6. Score obtained at Vineland Scale

    Time frame: Day 1

  7. Scores obtained at NEPSY-2 evaluation tests

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • Institut Pasteur
  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: MONALISABABY

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Oct 20, 2015
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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