CClinicalTrials.gg
CompletedNCT02580812MONALISABABYUpdated Sep 11, 2025

Neurological Consequences of Perinatal Listeriosis Infection

An interventional study of Clinical and neuropsychological evaluation procedure in Perinatal Listeriosis, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 5 Years to 6 Years. Per ClinicalTrials.gov, last updated 2025-09-11.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
53
Allocation
Non-randomized
Ages
5 Years to 6 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Perinatal Listeriosis

Keywords

  • Perinatal listeriosis
  • Neurological impairment
  • Sepsis
  • Prematurity
  • Neurotropism
  • Listeria monocytogenes
  • Intellectual Quotient
03

In context

Neurologic Manifestations

198 studies on the registry are indexed under Neurologic Manifestations; 67 are open to participants now.

This study's enrollment of 53 is above the median of 40 across 107 interventional studies indexed under Neurologic Manifestations.

Browse Neurologic Manifestations studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Children whose parents or legal representative would deny their consent
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    MONALISA 5-years old children

    Clinical and neuropsychological evaluation procedure 90 children

    Other: Clinical and neuropsychological evaluation procedure

  • 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

Interventions

  • OtherClinical and neuropsychological evaluation procedure

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

06

What researchers measure

Primary outcomes

  1. Reduction of > 20 points of the Intellectual Quotient

    Evaluated by standard tests (WPPSI-IV)

    Time frame: Day 1

Secondary outcomes

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

    to evaluate alteration of executive functions

    Time frame: Day 1

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

    to evaluate alteration of cognitive functions

    Time frame: Day 1

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

    to evaluate alteration of cognitive functions

    Time frame: Day 1

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

    to evaluate alteration of executive functions

    Time frame: Day 1

  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

07

Study locations

1 site
  • Hôpital Necker-Enfants Malades
    Paris, 75015, France
08

References and documents

Publications

  • Charlier C, Barrault Z, Rousseau J, Kermorvant-Duchemin E, Meyzer C, Semeraro M, Fall M, Coulpier G, Leclercq A, Charles MA, Ancel PY, Lecuit M. Long-term neurological and neurodevelopmental outcome of neonatal listeriosis in France: a prospective, matched, observational cohort study. Lancet Child Adolesc Health. 2023 Dec;7(12):875-885. doi: 10.1016/S2352-4642(23)00195-5. Epub 2023 Oct 20. PubMed 37871603 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02580812
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut Pasteur, Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Oct 20, 2015
Start date
Oct 26, 2015
Primary completion
Oct 29, 2018
Completion
Oct 29, 2018
Last update
Sep 11, 2025

Study contacts

Caroline CHARLIER-WOERTHER, MD, PhD
principal investigator · 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
Marc LECUIT, MD, PhD
study chair · 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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion