Clinical trial NCT04685850: Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans
Official title: Long-term Sequelae of Childhood Meningitis and Meningococcal Purpura Fulminans in Ile de France: a Multidisciplinary Approach
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Meningitis, Meningococcal
Sequela
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
Collaborators: name: Association Clinique Thérapeutique Infantile du val de Marne
First posted: 2020-12-28
Enrollment: 43
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children from 0 to 17 years old who had meningococcal meningitis between 2010 and 2019

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of children with at least one neurological, orthopedic or sensory sequelae
timeFrame: 1 year
Secondary outcomes:
measure: Number of children with severe neurological sequelae
timeFrame: 1 year
measure: Number of children with orthopedic complications
timeFrame: 1 year
measure: Number of children with sensory disorders
timeFrame: 1 year
measure: Number of children with skin sequelae
timeFrame: 1 year
measure: Number of children with learning disabilities
timeFrame: 1 year
measure: Number of children with cognitive or psychological difficulties identified on the WPPSI, WISC V or VINELAND depending on their age and capacity
timeFrame: 1 year
measure: Number of consultations during follow-up
timeFrame: 1 year
measure: Post-traumatic stress in parents using the IES-R questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
facility: CHU Bicêtre
state: Kremlin Bicêtre
city: Annecy
country: France
facility: CHU Annecy
city: Crosne
country: France
facility: Centre Intercommunal de Villeneuve Saint Georges
city: Créteil
country: France
facility: CHI créteil
city: Longjumeau
country: France
facility: Groupe Hospitalier Nord Essonne
city: Meaux
country: France
facility: GHEF site de Meaux
city: Paris
country: France
facility: Hôpital Necker Enfants Malades
city: Paris
country: France
facility: Robert debré hospital
city: Pontoise
country: France
facility: Ch Pontoise
Study officials:
References:
citation: 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.