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The Relevance of Performing Lumbar Puncture in Infants Aged 3 to 12 Months With First Episode of Febrile Convulsion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01443611
First Posted: September 30, 2011
Last Update Posted: September 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr Koren Ariel, HaEmek Medical Center, Israel
  Purpose
The actual recommendations for infants aged 3 to 12 months presented with first episode of Febrile Convulsions highly recommend performing lumbar puncture in order to rule out Bacterial Meningitis. On the other hand, recent studies in the era of anti Pneumococcal vaccination arise the question if in the presence of a normal physical examination those recommendations are still relevant. The purpose of this study is to summarized retrospectively the clinical records of all the infants admitted to the pediatric wards in the ten years period since 2000 to 2010 in order to record the incidence of Bacterial Meningitis among infants admitted with the First episode of Febrile Convulsions.

Condition
Febrile Convulsions

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Dr Koren Ariel, HaEmek Medical Center, Israel:

Primary Outcome Measures:
  • Number of patients with abnormal lumbar puncture [ Time Frame: One year ]
    The number of patients aged six months to one year that underwent lumbar puncture when they were admitted with simple febrile convulsions


Enrollment: 122
Study Start Date: June 2011
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Infants with first episode of Febrile Convlusions

Detailed Description:
Demographic data, including ethnic origin, age an gender will be recorded. The type of Convulsions (Simple or Complex), duration, and time since the fever was noticed will be also recorded. Another data that will be summarized included: previous antibiotic treatment, physical examination with special emphasis on neurological examination and meningeal signs, routine laboratory analysis including blood count and cerebrospinal fluid (CSF) results and the final diagnosis including the cause of fever.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Infants aged 3 to 12 months who presents with First Episode of Febrile Convulsions
Criteria

Inclusion Criteria:

  • Infants aged 3 to 12 months who presents with First Episode of Febrile Convulsions during the period 1/1/2000 until 31/12/2010

Exclusion Criteria:

  • infants with previous neurological diseases, or
  • recent neurological disease that are not included in the characteristics of Febrile Convulsion
  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): NCT01443611


Locations
Israel
Pediatric Dpt B - Ha'Emek Medical Center
Afula, Israel, 18101
Sponsors and Collaborators
HaEmek Medical Center, Israel
  More Information

Responsible Party: Dr Koren Ariel, Head of Pediatric Dpt B and Pediatric Hematology Unit, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT01443611     History of Changes
Other Study ID Numbers: 0138-10-EMC
First Submitted: September 27, 2011
First Posted: September 30, 2011
Last Update Posted: September 1, 2015
Last Verified: August 2015

Keywords provided by Dr Koren Ariel, HaEmek Medical Center, Israel:
Infants

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