Perinatal ListeriosisMONALISABABYNCT02580812
Neurological Consequences of Perinatal Listeriosis Infection
A study testing Clinical and neuropsychological evaluation procedure in people with Perinatal Listeriosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 5 to 6 years
- Conditions the study is for
- Perinatal Listeriosis
- What is being tested?
- Clinical and neuropsychological evaluation procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteFrance
- Study dates
- 26 Oct 2015to 29 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children whose parents or legal representative would deny their consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric Observational National Analysis of Listeriosis and Listeria : Evaluation of the 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.
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.
- Conditions
- Perinatal Listeriosis
- Being tested
- Clinical and neuropsychological evaluation procedure
- Keywords
- Perinatal listeriosis, Neurological impairment, Sepsis, Prematurity, Neurotropism, Listeria monocytogenes, Intellectual Quotient
- Medical subject headings
- Neurologic Manifestations, Sepsis, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and neuropsychological evaluation procedureOther
WPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination
| Study group | Role | What they receive |
|---|---|---|
| MONALISA 5-years old children | Experimental | Clinical and neuropsychological evaluation procedure 90 children Receives: Other: Clinical and neuropsychological evaluation procedure |
| EPIPAGE 5 -years old children | Active comparator | Cohort of prematurely borne children and their controls Clinical and neuropsychological evaluation procedure 270 children Receives: Other: Clinical and neuropsychological evaluation procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of > 20 points of the Intellectual Quotient
Evaluated by standard tests (WPPSI-IV)
Measured: Day 1
Secondary outcomes (7)
Score obtained at M-ABC evaluation test (Movement-ABC)
to evaluate alteration of executive functions
Measured: Day 1
Score obtained at SDQ evaluation test (Strenghts and Difficulties Questionnaire)
to evaluate alteration of cognitive functions
Measured: Day 1
Score obtained at SCQ evaluation test (Social Communication Questionnaire)
to evaluate alteration of cognitive functions
Measured: Day 1
Score obtained at BRIEF-P evaluation test (Behavior Rating Inventoring Executive Function)
to evaluate alteration of executive functions
Measured: Day 1
Score obtained at HOME evaluation test (Home Observation and Measurement of Environment)
Measured: Day 1
Score obtained at Vineland Scale
Measured: Day 1
Scores obtained at NEPSY-2 evaluation tests
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2015 (estimated)
- Study start26 Oct 2015
- Primary completion29 Oct 2018
- Study completion29 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perinatal ListeriosisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Pasteur, Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- 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 PasteurMarc 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02580812
- Sponsor's protocol ID
- P140940
- Acronym
- MONALISABABY
- Status last verified
- Sep 2025
- First submitted
- 31 Aug 2015
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Observational National Analysis of Listeriosis and Listeria : Evaluation of the Neurological Consequences of Perinatal Listeriosis Infection
- ClinicalTrials.gov ID
- NCT02580812
- Acronym / sponsor ID
- MONALISABABY / P140940
- Conditions
- Perinatal Listeriosis
- Keywords
- Perinatal listeriosis, Neurological impairment, Sepsis, Prematurity, Neurotropism, Listeria monocytogenes, Intellectual Quotient
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut Pasteur, Institut National de la Santé Et de la Recherche Médicale, France, URC-CIC Paris Descartes Necker Cochin
- Study start
- 26 Oct 2015 (actual)
- Primary completion
- 29 Oct 2018 (actual)
- Study completion
- 29 Oct 2018 (actual)
- First posted
- 20 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MONALISA 5-years old children | Experimental | Other: Clinical and neuropsychological evaluation procedureClinical and neuropsychological evaluation procedure 90 children |
| EPIPAGE 5 -years old children | Active comparator | Other: Clinical and neuropsychological evaluation procedureCohort of prematurely borne children and their controls Clinical and neuropsychological evaluation procedure 270 children |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Children whose parents or legal representative would deny their consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and neuropsychological evaluation procedureWPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination | Other | EPIPAGE 5 -years old children, MONALISA 5-years old children |
Primary outcome
Reduction of > 20 points of the Intellectual Quotient
Time frame: Day 1
Evaluated by standard tests (WPPSI-IV)
7 secondary outcomes
Score obtained at M-ABC evaluation test (Movement-ABC)
Time frame: Day 1
Score obtained at SDQ evaluation test (Strenghts and Difficulties Questionnaire)
Time frame: Day 1
Score obtained at SCQ evaluation test (Social Communication Questionnaire)
Time frame: Day 1
Score obtained at BRIEF-P evaluation test (Behavior Rating Inventoring Executive Function)
Time frame: Day 1
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Results publication: PubMed 37871603Charlier 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and neuropsychological evaluation procedure in people with Perinatal Listeriosis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of > 20 points of the Intellectual Quotient (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02580812, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.