Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans (SEINE)

Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans in Ile de France: a Multidisciplinary Approach

While the initial evolution of meningococcal meningitis (MM) is well described, there are few data on the long-term evolution, beyond 1 year.

The objective of this research is to evaluate the sequelae of MM beyond 1 year in patients with a history of MM followed in Paris area, France. Most children with MM in France have been included in the MM register and are still being followed. Parents will be offered a detailed clinical evaluation of their child including: a clinical and neurological examination, a cognitive performance assessment, an auditory, speech and visual assessment and an evaluation of the child's progress at school.

Study Overview

• Status: Terminated
• Conditions: Meningitis, Meningococcal; Sequela
• Intervention / Treatment: Other: sequela evaluation

• Study Type: Observational
• Enrollment (Actual): 43

Contacts and Locations

Study Locations

• France
  • Annecy, France, 74370
    • CHU Annecy
  • Crosne, France, 91560
    • Centre Intercommunal de Villeneuve Saint Georges
  • Créteil, France, 94000
    • Chi Creteil
  • Longjumeau, France, 91345
    • Groupe Hospitalier Nord Essonne
  • Meaux, France, 77100
    • GHEF Site de Meaux
  • Paris, France, 75015
    • Hopital Necker Enfants Malades
  • Paris, France, 75019
    • Robert Debré Hospital
  • Pontoise, France, 95300
    • CH Pontoise
  • Kremlin Bicêtre
    • Le Kremlin Bicêtre, Kremlin Bicêtre, France, 94720
      • CHU Bicêtre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children from 0 to 17 years old who had meningococcal meningitis between 2010 and 2019

Description

Inclusion Criteria:

• Infants and children from 0 to 17 years old
• Having had meningitis or meningococcal purpura fulminans between 2010 and 2021
• Delay ≥ 1 year between the date of diagnosis of meningitis or purpura meningococcal fulminans and the date of inclusion in the study (signature of the informed consent)
• The holders of parental authority have read and understood the information letter and their express consent has been obtained
• Patient affiliated to a social security system (Social Security or Universal Medical Coverage)

Exclusion Criteria:

• refusal to participate

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of children with at least one neurological, orthopedic or sensory sequelae	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of children with severe neurological sequelae		1 year
Number of children with orthopedic complications		1 year
Number of children with sensory disorders		1 year
Number of children with skin sequelae		1 year
Number of children with learning disabilities		1 year
Number of children with cognitive or psychological difficulties identified on the WPPSI, WISC V or VINELAND depending on their age and capacity	95% of the population has a Total IQ between 70 and 130 (from low intelligence to high intelligence).	1 year
Number of consultations during follow-up		1 year
Post-traumatic stress in parents using the IES-R questionnaire	A score up to 33 is associated with a stress post traumatic	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Collaborators: Association Clinique Thérapeutique Infantile du val de Marne

Publications and helpful links

General Publications

• Baloche A, Jung C, Levy M, Elbez-Rubinstein A, Bechet S, Layouni I, Monguillot G, Taha MK, Cohen R, Levy C. Long-term impact of invasive meningococcal disease in children: SEINE study protocol. PLoS One. 2022 May 26;17(5):e0268536. doi: 10.1371/journal.pone.0268536. eCollection 2022.

Helpful Links

• Long-term impact of invasive meningococcal disease in children: SEINE study protocol

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2021
• Primary Completion (Actual): May 19, 2025
• Study Completion (Actual): May 19, 2025

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Infections; Hemorrhage; Skin Manifestations; Hematologic Diseases; Blood Coagulation Disorders; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Central Nervous System Infections; Neisseriaceae Infections; Meningitis, Bacterial; Central Nervous System Bacterial Infections; Meningococcal Infections; Purpura; Meningitis; Meningitis, Meningococcal; Purpura Fulminans
• Other Study ID Numbers: SEINE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No