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Nervous System Infections Among Patients With Febrile Seizure

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ClinicalTrials.gov Identifier: NCT01694524
Recruitment Status : Completed
First Posted : September 27, 2012
Last Update Posted : May 20, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Seizure Febrile Seizure Meningitis Encephalitis

Study Design

Study Type : Observational
Actual Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Nervous System Infections Among Patients With Febrile Seizure : Retrospective Cohort Review of Consecutive Patients Admitted in 7 Pediatric Emergency Departments in Ile-de-France Between 2007 and 2011
Study Start Date : June 2013
Primary Completion Date : March 2014
Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Seizures
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Bacterial meningitis [ Time Frame: 7 days after emergency visit ]
    Results of lumbar puncture or meningitis history in charts

  2. Herpes simplex virus meningitis/encephalitis [ Time Frame: 7 days after emergency visit ]
    Results of lumbar puncture or meningitis history in charts


Secondary Outcome Measures :
  1. emergent intracranial processus [ Time Frame: 7 days after emergency visit ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

Inclusion Criteria:

  • febrile (>38°)
  • Seizure

Exclusion Criteria:

  • previous non febrile seizure
  • known trauma
  • immunodeficiancy status
  • Underlying illness
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01694524


Locations
France
Hopital Jean Verdier
Bondy, France, 93140
Centre hospitalier intercommunal de creteil
Creteil, France, 94010
Centre hospitalier Lagny-Marne la Vallée
Lagny-Sur-Marne, France, 77405
Centre hospitalier de Versailles
Le chesnay, France, 78157
Hôpital Armand Trousseau
Paris, France, 75012
Hopital Robert Debré
Paris, France, 75019
Centre hospitalier intercommunal de Poissy
Poissy, France, 78300
Sponsors and Collaborators
Hôpital Armand Trousseau
Robert Debré Hospital
Hôpital Jean Verdier
Centre Hospitalier Intercommunal Creteil
Centre hospitalier de versailles
Centre hospitalier Lagny Marne la vallée
Centre hospitalier intercommunal de Poissy
Investigators
Principal Investigator: Ricardo Carbajal, MD, PhD Hôpital Armand Trousseau, Paris
More Information

Responsible Party: CARBAJAL, Professor, Hôpital Armand Trousseau
ClinicalTrials.gov Identifier: NCT01694524     History of Changes
Other Study ID Numbers: febrile seizure and infection
First Posted: September 27, 2012    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

Additional relevant MeSH terms:
Seizures
Meningitis
Encephalitis
Fever
Seizures, Febrile
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Body Temperature Changes