Nervous System Infections Among Patients With Febrile Seizure

NCT01694524 | Completed

• 1 other identifier: febrile seizure and infection
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 7

Brief Summary

Few studies dealing with the risk of infectious of nervous system and the utility of lumbar puncture and of emergent neuroimaging among patients with simple febrile seizure between 3 and 11 months age and with complex seizure has been reported. None of these studies was multicentric. Recommendations about management of these children are heterogeneous. The investigators aim to study by an observational retrospective multicentric study the rate of infectious of central nervous system among patients with a complex febrile seizure and among patients between 3 and 11 months age with simple febrile seizure.

Conditions

Seizure; Febrile Seizure; Meningitis; Encephalitis

Outcome Measures

Primary Outcomes (2)

• Bacterial meningitis

  Results of lumbar puncture or meningitis history in charts

  7 days after emergency visit

• Herpes simplex virus meningitis/encephalitis

  Results of lumbar puncture or meningitis history in charts

  7 days after emergency visit

Secondary Outcomes (1)

• emergent intracranial processus

  7 days after emergency visit

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective cohort review of consecutive patients admitted in 7 pediatric emergency departments in Ile-de-France between 2007 and 2011. All clinically well-apparent children 3 to 11 months of age with a first simple febrile seizure were included in the study. All children between 3 months and 5 years with a complex febrile seizure were included

You may qualify if:

• febrile (\>38°)
• Seizure

You may not qualify if:

• previous non febrile seizure
• known trauma
• immunodeficiancy status
• Underlying illness

Sponsors & Collaborators

• Hôpital Armand Trousseau: lead
• Hopital Universitaire Robert-Debre: collaborator
• Hôpital Jean Verdier: collaborator
• Centre Hospitalier Intercommunal Creteil: collaborator
• Versailles Hospital: collaborator
• Centre hospitalier Lagny Marne la vallée: collaborator
• Centre hospitalier intercommunal de Poissy: collaborator

Study Sites (7)

Hopital Jean Verdier

Bondy, 93140, France

Location

Centre hospitalier intercommunal de creteil

Créteil, 94010, France

Location

Centre hospitalier Lagny-Marne la Vallée

Lagny-sur-Marne, 77405, France

Location

Centre hospitalier de Versailles

Le Chesnay, 78157, France

Location

Hôpital Armand Trousseau

Paris, 75012, France

Location

Hopital Robert Debré

Paris, 75019, France

Location

Centre hospitalier intercommunal de Poissy

Poissy, 78300, France

Location

MeSH Terms

Conditions

Seizures; Seizures, Febrile; Meningitis; Encephalitis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neuroinflammatory Diseases; Brain Diseases; Central Nervous System Diseases

Study Officials

• Ricardo Carbajal, MD, PhD

  Hôpital Armand Trousseau, Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 24, 2012
• First Posted: September 27, 2012
• Study Start: June 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

FR (7)